Another study documenting that emergency department Screening, Brief Intervention and Referral to Treatment (SBIRT) doesn't work. Unfortunately, advocates for SBIRT have moved out quite a ways ahead of the evidence. This is not likely to be harmful for patients, obviously, but it may hurt the cause in the long run. It's also a waste of money and time. By the way, the same holds true for hospitalized patients. SBIRT doesn't work because most of the patients identified are dependent drinkers.
MW
Oxford Journals
Medicine
Alcohol and Alcoholism
Volume45, Issue6
Pp. 514-519.
The Impact of Screening, Brief Intervention and Referral for Treatment in Emergency Department Patients’ Alcohol Use: A 3-, 6- and 12-month Follow-up
Academic ED SBIRT Research Collaborative
Corresponding author: Robert H. Aseltine, Jr., Division of Behavioral Sciences and Community Health, MC 3910, University of Connecticut Health Center, 263 Farmington Avenue, Farmington, CT 06030-3910, USA. Tel: +1 860 679 3282; Fax: +1 860 679 1342; E-mail: aseltine@uchc.edu
Received October 26, 2009.
Revision received July 30, 2010.
Accepted August 23, 2010.
Abstract
Aims: This study aims to determine the impact of Screening, Brief Intervention and Referral for Treatment (SBIRT) in reducing alcohol consumption in emergency department (ED) patients at 3, 6, and 12 months following exposure to the intervention. Methods: Patients drinking above the low-risk limits (at-risk to dependence), as defined by National Institute of Alcohol Abuse and Alcoholism (NIAAA), were recruited from 14 sites nationwide from April to August 2004. A quasi-experimental comparison group design included sequential recruitment of intervention and control patients at each site. Control patients received a written handout. The Intervention group received the handout and participated in a brief negotiated interview with direct referral for treatment if indicated. Follow-up surveys were conducted at 3, 6, and 12 months by telephone using an Interactive Voice Response (IVR) system. Results: Of the 1132 eligible patients consented and enrolled (581 control, 551 intervention), 699 (63%), 575 (52%) and 433 (38%) completed follow-up surveys via IVR at 3, 6, and 12 months, respectively. Regression analysis adjusting for the clustered sampling design and using multiple imputation procedures to account for subject attrition revealed that those receiving SBIRT reported roughly three drinks less per week than controls (B = −3.00, SE = 1.06, P < 0.05) and the level of maximum drinks per occasion was approximately three-fourths of a drink less than controls (B = -0.76, SE = 0.29, P < 0.05) at 3 months. At 6 and 12 months post-intervention, these effects had weakened considerably and were no longer statistically or substantively significant. Conclusion: SBIRT delivered by ED providers appears to have short-term effectiveness in reducing at-risk drinking, but multi-contact interventions or booster programs may be necessary to maintain long-term reductions in risky drinking.
Monday, February 28, 2011
Sunday, February 27, 2011
Charlie Sheen on the Myths of Rehab - Time Gets It Right!
Here's a brief snippet from Maia Szalavitz, a health reporter at Time. She really hits the facts right on.
MW
Can You Use Crack 'Socially?' Addiction Myth Watch: Charlie Sheen Edition
By Maia Szalavitz Tuesday, February 15, 2011
The subject of addiction swirls with myths and misinformation. It doesn't help that so many people seem to believe that their own struggle with addiction — or a few drop-ins to Alcoholics Anonymous meetings — make them unquestionable experts on the topic. As the latest news about Charlie Sheen's escapades show, sometimes the seemingly crazy statements of an apparently active addict can be more accurate than those of people who have spent years in recovery and even some "addiction experts" — if you go by the science, that is. (More on Time.com: New Hope For An Anti-Cocaine Vaccine)
Myth One: Everyone Who Takes Crack Is An Addict
On Monday, during a radio interview with the sports-talk "Dan Patrick Show," Sheen mentioned that some crack users can "manage it socially." (He said his own attempts to be a social crack user "kind of blew up in my face. Like an exploding crack pipe, Dan.")
Although crack cocaine is indeed one of the most addictive drugs, Sheen's statement about social use is true of most people who have tried the drug, if by "social" you mean use that does not qualify you for a diagnosis of substance dependence. Far from being universally addictive, crack is actually unattractive to the majority of people who've tried it: only about 15%-20% of initial users become hooked. (More on Time.com: Bonus: 4 Tips for Staying on the Wagon)
Indeed, according to data from the National Survey on Drug Use and Health, about 75.6% of those who tried crack between 2004 and 2006 were not using it at all two years later. Another 15% were still hitting the pipe occasionally, but not at levels that would qualify them as addicts. About 9.2% were addicted.
So, although Sheen's terminology may be inexact, he's correct about the existence of non-addicted crack users. He's also correct to note that drinking chocolate milk is much, much safer.
Myth Two: Residential Treatment Works Better than Outpatient Treatment, and Must Be Done in Groups
People magazine recently reported that Sheen would go into treatment for substance abuse for the third time, this time at home: "Surrounded by a team of professionals, the Two and Half Men star will attend no meetings with other patients, check into no center. He could do it all at home or in some other private setting." (More on Time.com: Does Suffering From Withdrawal Really Mean You're Addicted?)
Commenting on Sheen's rehab plan, Dr. Drew told the magazine that "treatment of addiction is a group process when done properly — not an individual thing at all." Yet actual addiction research shows this is not the case. For example, the largest study ever done on alcoholism treatment, Project Match, was conducted mainly through individual therapy sessions (though one arm did focus on improving 12-step group participation): its aim was not to compare individual to group treatment, but overall, it found individual treatment just as successful.
Further, studies that have directly compared inpatient treatment to outpatient therapy have found that there is little difference in outcomes for most addicts, except for very severe cases, particularly amongst the homeless and jobless — these people lack social and family support, or other important goals to work toward, things that have been found to aid recovery. For employed professionals — like Sheen — outpatient and inpatient treatment tend to be equally effective. (More on Time.com: 'i-Dosing': Can You Download a Drug High?)
Myth Three: 12-Step Programs are Required for Recovery
Although celebrities, including Sheen's own father, swear by them, 12-step programs like Alcoholics Anonymous are not the only way to recover from addiction. Project Match, in fact, found that on most measures, cognitive behavioral therapy and motivational enhancement therapy were as effective as 12-step facilitation (TSF), a program that worked to enhance 12-step attendance. When patients received these therapies as after-care following inpatient treatment, all three groups did equally well. However, in outpatient-treated addicts, those in the TSF group had slightly better rates of complete abstinence in the year following treatment. (More on Time.com: Study: Do Energy Drinks Lead to Alcohol Abuse?)
So, although Sheen may not exactly be a model citizen — or rehab patient — his distaste for 12-step programs does not mean that he's untreatable. Maybe he just needs to find a rehab or addiction "professional" who is familiar with the scientific literature.
Find this article at:
http://healthland.time.com/2011/02/15/can-you-use-crack-socially-addiction-myth-watch-charlie-sheen-edition/
MW
Can You Use Crack 'Socially?' Addiction Myth Watch: Charlie Sheen Edition
By Maia Szalavitz Tuesday, February 15, 2011
The subject of addiction swirls with myths and misinformation. It doesn't help that so many people seem to believe that their own struggle with addiction — or a few drop-ins to Alcoholics Anonymous meetings — make them unquestionable experts on the topic. As the latest news about Charlie Sheen's escapades show, sometimes the seemingly crazy statements of an apparently active addict can be more accurate than those of people who have spent years in recovery and even some "addiction experts" — if you go by the science, that is. (More on Time.com: New Hope For An Anti-Cocaine Vaccine)
Myth One: Everyone Who Takes Crack Is An Addict
On Monday, during a radio interview with the sports-talk "Dan Patrick Show," Sheen mentioned that some crack users can "manage it socially." (He said his own attempts to be a social crack user "kind of blew up in my face. Like an exploding crack pipe, Dan.")
Although crack cocaine is indeed one of the most addictive drugs, Sheen's statement about social use is true of most people who have tried the drug, if by "social" you mean use that does not qualify you for a diagnosis of substance dependence. Far from being universally addictive, crack is actually unattractive to the majority of people who've tried it: only about 15%-20% of initial users become hooked. (More on Time.com: Bonus: 4 Tips for Staying on the Wagon)
Indeed, according to data from the National Survey on Drug Use and Health, about 75.6% of those who tried crack between 2004 and 2006 were not using it at all two years later. Another 15% were still hitting the pipe occasionally, but not at levels that would qualify them as addicts. About 9.2% were addicted.
So, although Sheen's terminology may be inexact, he's correct about the existence of non-addicted crack users. He's also correct to note that drinking chocolate milk is much, much safer.
Myth Two: Residential Treatment Works Better than Outpatient Treatment, and Must Be Done in Groups
People magazine recently reported that Sheen would go into treatment for substance abuse for the third time, this time at home: "Surrounded by a team of professionals, the Two and Half Men star will attend no meetings with other patients, check into no center. He could do it all at home or in some other private setting." (More on Time.com: Does Suffering From Withdrawal Really Mean You're Addicted?)
Commenting on Sheen's rehab plan, Dr. Drew told the magazine that "treatment of addiction is a group process when done properly — not an individual thing at all." Yet actual addiction research shows this is not the case. For example, the largest study ever done on alcoholism treatment, Project Match, was conducted mainly through individual therapy sessions (though one arm did focus on improving 12-step group participation): its aim was not to compare individual to group treatment, but overall, it found individual treatment just as successful.
Further, studies that have directly compared inpatient treatment to outpatient therapy have found that there is little difference in outcomes for most addicts, except for very severe cases, particularly amongst the homeless and jobless — these people lack social and family support, or other important goals to work toward, things that have been found to aid recovery. For employed professionals — like Sheen — outpatient and inpatient treatment tend to be equally effective. (More on Time.com: 'i-Dosing': Can You Download a Drug High?)
Myth Three: 12-Step Programs are Required for Recovery
Although celebrities, including Sheen's own father, swear by them, 12-step programs like Alcoholics Anonymous are not the only way to recover from addiction. Project Match, in fact, found that on most measures, cognitive behavioral therapy and motivational enhancement therapy were as effective as 12-step facilitation (TSF), a program that worked to enhance 12-step attendance. When patients received these therapies as after-care following inpatient treatment, all three groups did equally well. However, in outpatient-treated addicts, those in the TSF group had slightly better rates of complete abstinence in the year following treatment. (More on Time.com: Study: Do Energy Drinks Lead to Alcohol Abuse?)
So, although Sheen may not exactly be a model citizen — or rehab patient — his distaste for 12-step programs does not mean that he's untreatable. Maybe he just needs to find a rehab or addiction "professional" who is familiar with the scientific literature.
Find this article at:
http://healthland.time.com/2011/02/15/can-you-use-crack-socially-addiction-myth-watch-charlie-sheen-edition/
Monday, February 7, 2011
Addiction Treatment Parity Doesn't Add Costs
Contrary to the hysterical warnings issued by the insurance industry and the Chamber of Commerce, it turns out that parity for addiction treatment does not add significantly to costs. One key reason is underutilization. Replacing the expensive and minimally effective rehab approach with a fully professional, scientifically based approach will not only make treatment even more cost effective, it will increase access to and utilization of treatment.
MLW
From Medscape Medical News > Psychiatry
No Increase in Substance Abuse Treatment Due to Mental Health Parity Law
Findings Should Squelch Fears That Controversial Legislation Will Cause Health Costs to Skyrocket
Deborah Brauser
February 4, 2011 — Parity in insurance coverage of substance abuse treatment has not led to increased use of this service or an increase in costs. It has done what it was designed to do — lower out-of-pocket expenses for covered individuals, new research suggests.
Employers who provide health insurance plans for mental and substance use disorders are now required by the Federal Mental Health Parity Act of 2008 to provide benefits that are equal to those given for general medical care.
There is always a fear that for substance abuse and for mental health, every time a plan is more generous, utilization will skyrocket...But this is not true.
"There is always a fear that for substance abuse and for mental health, every time a plan is more generous, the utilization will skyrocket, the costs will be so high, and all the insurance companies will start complaining that they won't be able to afford these services. But this is not true," lead study author Vanessa Azzone, PhD, researcher and biostatistician in the Department of Health Care Policy at Harvard Medical School in Boston, Massachusetts, told Medscape Medical News.
"I think these findings, along with those found in other studies, clear the air for all the people who have been criticizing parity law for mental health treatment," said Dr. Azzone.
The investigators note that the extensive use of managed care organizations (MCOs) within employer-based health insurance may be the reason for costs not rising.
"These MCOs administer behavioral health benefits and contain costs by managing the delivery of care — for example, through negotiated reduction in fees with a network of preferred providers and review of appropriateness of services to eliminate unnecessary use," they explain.
"Still, it's always a balance between getting more for the patient but also, from the plan side, controlling that services are only provided as needed," added Dr. Azzone.
The study is published in the February issue of Psychiatric Services.
Paucity of Research
Although previous research on the impact of mental health parity mandates "has undoubtedly helped to pave the way for passage of comprehensive federal legislation," there have been few studies on the effects of parity mandates for substance abuse treatment benefits, write the study authors.
"This is a group that is not studied as much. They're pretty sick and their services are very expensive. So there's been fear that the parity law could have a real impact," said Dr. Azzone.
Insurance plans for federal workers have been required to provide parity coverage since 2001. Because of this, the investigators decided to evaluate claims data on substance abuse treatment in 6 Federal Employees Health Benefit (FEHB) preferred provider organization plans between 1999 and 2001 (before parity was implemented) and between 2001 and 2002 (after implementation).
The use and costs of these plans were then compared with those found in a matched set of health plans without parity coverage.
Results showed no statistically significant differences in the use of substance abuse treatment services between the 2 plan types and no significant differences in probability rates of initiation and engagement.
Those enrolled in the FEHB plans had a significantly larger reduction in average out-of-pocket spending for these services (mean difference per user, −$101.09; P < .05) compared with those in the non-FEHB plans.
Although the FEHB group also had smaller increases in total substance abuse spending compared with the non-FEHB group, these differences were not significant.
Finally, more of the patients with parity were identified by their care providers as having a substance use disorder (difference-in-difference risk, 0.10; 95% confidence interval, 0.02 to 0.19; P < .05).
"Findings suggest that for continuously enrolled populations, providing parity of substance abuse treatment coverage improved insurance protection but had little impact on utilization, costs for plans, or quality of care," write the researchers.
Clinicians' 'Biggest Stress'
According to Dr. Azzone clinicians' biggest stress is trying to get paid for services because insurance companies erect so many barriers to reimbursement.
"Still, there is this law, and I think clinicians should push more for their patients, even if it is hard for them to promote services when they have so many obstacles. This is already a population that finds it very hard to engage in and continue to get services," she said.
She added that her team is conducting other studies looking at the possibility of parity coverage differences for other groups.
"This includes patients with bipolar disorder or major depression that usually are more expensive and require more services. These patient populations could have a differential effect. We're also concentrating on children to see if the effect we found in adults overall is the same or not," she explained.
"I think this study is significant and an important step in the analysis of overall healthcare costs," Anita S. Everett, MD, director of Community Psychiatry Services at Johns Hopkins Bayview Medical Center in Baltimore, Maryland, told Medscape Medical News.
Dr. Anita Everett
"Providing parity for substance abuse services didn't increase the overall costs. And that is the big fear that everyone has — open the floodgates and all these people will want these very expensive services," said Dr. Everett, who was not involved with this study.
"Also, the number of individuals who actually sought the services didn't go up that much. I think that that is important, although not shocking, and consistent with what we already know: a lot of people with a substance abuse disorder don't recognize their need for treatment or are unwilling to seek treatment. Offering parity is not all of a sudden going to break down their resistance."
Dr. Everett pointed out that a big part of "substance abuse disease" is to be in denial about the magnitude of the problem.
Parity Law Won't 'Break the Bank'
"The clinical significance of parity is that it enables a clinician to be able to help patients and to 'strike while the iron is hot,' so to speak. If they're at a point where they're ready, then hopefully we'll be able to immediately meet that readiness," she said.
Dr. Everett, who is also chair of the American Psychiatric Association's Council on Healthcare Systems and Finance, said that some primary care physicians might not be aware that the parity law has passed.
"I know that the American Psychiatric Association, along with a number of other organizations, is actively working to promote awareness for healthcare providers, patients, and their families that parity for substance abuse and for mental health services does exist," she said.
"I also think that resources such as referral services should be collected and offered in primary care offices."
I think this is critical information that helps us understand that enabling access to some of these services is not going to break the bank.
She noted that, although these findings are important, the study population might not be representative of all groups in the United States.
"These were people who were fairly motivated and are probably comparable to other private pay insurance groups — but maybe not to the Medicare or Medicaid populations. We know it can give us some ideas about applicability to the general public, but it may or may not be predictive of the other 300 million Americans who are not federal employees," explained Dr. Everett.
"However, I think this is critical information that helps us understand that enabling access to some of these services is not going to break the bank."
The study was funded by a grant from the National Institute on Drug Abuse through the Brandeis-Harvard Center for Managed Care and Drug Abuse Treatment. Its data were originally collected in a study funded by the Department of Health and Human Services. The study authors and Dr. Everett have disclosed no relevant financial relationships.
Psychiatr Serv. 2011;62:129-134.
Medscape Medical News © 2011 WebMD, LLC
Send comments and news tips to news@medscape.net.
MLW
From Medscape Medical News > Psychiatry
No Increase in Substance Abuse Treatment Due to Mental Health Parity Law
Findings Should Squelch Fears That Controversial Legislation Will Cause Health Costs to Skyrocket
Deborah Brauser
February 4, 2011 — Parity in insurance coverage of substance abuse treatment has not led to increased use of this service or an increase in costs. It has done what it was designed to do — lower out-of-pocket expenses for covered individuals, new research suggests.
Employers who provide health insurance plans for mental and substance use disorders are now required by the Federal Mental Health Parity Act of 2008 to provide benefits that are equal to those given for general medical care.
There is always a fear that for substance abuse and for mental health, every time a plan is more generous, utilization will skyrocket...But this is not true.
"There is always a fear that for substance abuse and for mental health, every time a plan is more generous, the utilization will skyrocket, the costs will be so high, and all the insurance companies will start complaining that they won't be able to afford these services. But this is not true," lead study author Vanessa Azzone, PhD, researcher and biostatistician in the Department of Health Care Policy at Harvard Medical School in Boston, Massachusetts, told Medscape Medical News.
"I think these findings, along with those found in other studies, clear the air for all the people who have been criticizing parity law for mental health treatment," said Dr. Azzone.
The investigators note that the extensive use of managed care organizations (MCOs) within employer-based health insurance may be the reason for costs not rising.
"These MCOs administer behavioral health benefits and contain costs by managing the delivery of care — for example, through negotiated reduction in fees with a network of preferred providers and review of appropriateness of services to eliminate unnecessary use," they explain.
"Still, it's always a balance between getting more for the patient but also, from the plan side, controlling that services are only provided as needed," added Dr. Azzone.
The study is published in the February issue of Psychiatric Services.
Paucity of Research
Although previous research on the impact of mental health parity mandates "has undoubtedly helped to pave the way for passage of comprehensive federal legislation," there have been few studies on the effects of parity mandates for substance abuse treatment benefits, write the study authors.
"This is a group that is not studied as much. They're pretty sick and their services are very expensive. So there's been fear that the parity law could have a real impact," said Dr. Azzone.
Insurance plans for federal workers have been required to provide parity coverage since 2001. Because of this, the investigators decided to evaluate claims data on substance abuse treatment in 6 Federal Employees Health Benefit (FEHB) preferred provider organization plans between 1999 and 2001 (before parity was implemented) and between 2001 and 2002 (after implementation).
The use and costs of these plans were then compared with those found in a matched set of health plans without parity coverage.
Results showed no statistically significant differences in the use of substance abuse treatment services between the 2 plan types and no significant differences in probability rates of initiation and engagement.
Those enrolled in the FEHB plans had a significantly larger reduction in average out-of-pocket spending for these services (mean difference per user, −$101.09; P < .05) compared with those in the non-FEHB plans.
Although the FEHB group also had smaller increases in total substance abuse spending compared with the non-FEHB group, these differences were not significant.
Finally, more of the patients with parity were identified by their care providers as having a substance use disorder (difference-in-difference risk, 0.10; 95% confidence interval, 0.02 to 0.19; P < .05).
"Findings suggest that for continuously enrolled populations, providing parity of substance abuse treatment coverage improved insurance protection but had little impact on utilization, costs for plans, or quality of care," write the researchers.
Clinicians' 'Biggest Stress'
According to Dr. Azzone clinicians' biggest stress is trying to get paid for services because insurance companies erect so many barriers to reimbursement.
"Still, there is this law, and I think clinicians should push more for their patients, even if it is hard for them to promote services when they have so many obstacles. This is already a population that finds it very hard to engage in and continue to get services," she said.
She added that her team is conducting other studies looking at the possibility of parity coverage differences for other groups.
"This includes patients with bipolar disorder or major depression that usually are more expensive and require more services. These patient populations could have a differential effect. We're also concentrating on children to see if the effect we found in adults overall is the same or not," she explained.
"I think this study is significant and an important step in the analysis of overall healthcare costs," Anita S. Everett, MD, director of Community Psychiatry Services at Johns Hopkins Bayview Medical Center in Baltimore, Maryland, told Medscape Medical News.
Dr. Anita Everett
"Providing parity for substance abuse services didn't increase the overall costs. And that is the big fear that everyone has — open the floodgates and all these people will want these very expensive services," said Dr. Everett, who was not involved with this study.
"Also, the number of individuals who actually sought the services didn't go up that much. I think that that is important, although not shocking, and consistent with what we already know: a lot of people with a substance abuse disorder don't recognize their need for treatment or are unwilling to seek treatment. Offering parity is not all of a sudden going to break down their resistance."
Dr. Everett pointed out that a big part of "substance abuse disease" is to be in denial about the magnitude of the problem.
Parity Law Won't 'Break the Bank'
"The clinical significance of parity is that it enables a clinician to be able to help patients and to 'strike while the iron is hot,' so to speak. If they're at a point where they're ready, then hopefully we'll be able to immediately meet that readiness," she said.
Dr. Everett, who is also chair of the American Psychiatric Association's Council on Healthcare Systems and Finance, said that some primary care physicians might not be aware that the parity law has passed.
"I know that the American Psychiatric Association, along with a number of other organizations, is actively working to promote awareness for healthcare providers, patients, and their families that parity for substance abuse and for mental health services does exist," she said.
"I also think that resources such as referral services should be collected and offered in primary care offices."
I think this is critical information that helps us understand that enabling access to some of these services is not going to break the bank.
She noted that, although these findings are important, the study population might not be representative of all groups in the United States.
"These were people who were fairly motivated and are probably comparable to other private pay insurance groups — but maybe not to the Medicare or Medicaid populations. We know it can give us some ideas about applicability to the general public, but it may or may not be predictive of the other 300 million Americans who are not federal employees," explained Dr. Everett.
"However, I think this is critical information that helps us understand that enabling access to some of these services is not going to break the bank."
The study was funded by a grant from the National Institute on Drug Abuse through the Brandeis-Harvard Center for Managed Care and Drug Abuse Treatment. Its data were originally collected in a study funded by the Department of Health and Human Services. The study authors and Dr. Everett have disclosed no relevant financial relationships.
Psychiatr Serv. 2011;62:129-134.
Medscape Medical News © 2011 WebMD, LLC
Send comments and news tips to news@medscape.net.
Tuesday, February 1, 2011
ALLTYR™ Is Born!
Over the past year, I have blogged and spoken about the need for transformational change in the addiction treatment system. This week, we took a major step towards stimulating that change, by forming a corporate structure for clinical, educational, advocacy and research efforts. ALLTYR™, the name of the organization, has now been incorporated in Minnesota!
There are two major areas of activity. The first is to develop a model for 21st Century specialty addition treatment. Built on a foundation of science, compassion and common sense, the ALLTYR™ Clinic will provide medically based, multidisciplinary evaluation and treatment for the entire spectrum of substance use disorders. The Clinic will use the ASSET™ Model of care. ASSET™ stands for Alcohol and Substance Use Screening, Evaluation and Treatment. We will provide comprehensive evaluations with recommendations for any indicated treatment. The ASSET Clinic will have several areas of specific expertise, including impaired professionals and executives, managing patients with brain injuries, complex chronic pain management, patients with serious medical problems such as cirrhosis and pancreatitis, patients with treatment-resistant alcohol or drug addiction and patients with complex mixes of psychiatric, medical and addictive disorders. The planned opening for the ASSET Clinic is Fall 2011, although we may be able to start accepting patients sooner.
The second focus for ALLTYR will be to help existing healthcare organizations address substance use throughout their system of care. Most people who drink too much or use other psychoactive drugs are not addicted, but are “at-risk” users. That is, they are using at a level that places them at elevated risk for developing problems later. They are currently not symptomatic. For example, someone drinking 4 or 5 drinks several days a week, or using marijuana several times a week, but who does not endorse any criteria for substance dependence. For this group, who do not have a diagnosable disorder, the goal is to counsel them about their use, so as to reduce the risk. They are similar to people with high cholesterol before a heart attack, or high blood pressure before a stroke. Treatment is not appropriate for them. This group is quite responsive to brief counseling, either by health care clinicians or on the internet, by workplace health initiatives, and so forth. When I was at NIH, we developed a product specifically for at-risk drinkers called Rethinking Drinking.
The second group are people who have some symptoms of alcohol addiction (or dependence, these are interchangeable terms) but who are functional. This group primarily endorses symptoms such as repeatedly going over limits, a persistent desire to quit or cut down, and use despite physical or psychological problems caused or exacerbated by their use, such as hangover, nausea, or insomnia. They do not have the kind of problems we usually associate with addiction such as major life disruptions involving employment, parenting, school performance, or serious interpersonal or legal problems. This group, called functional alcohol dependents, are not appropriate for specialty addiction treatment, but respond well to medications and brief support, much like mild to moderate depression is treated in primary care. Both of these groups are best dealt with in non-addiction specialty settings such as primary care or mental health care (general psychiatry).
For these groups, ALLTYR will provide consultation and training for existing health care systems. The goal is to help them address substance use throughout their healthcare system. For too long it has been considered forbidden for anyone but an addiction counselor to address substance use, which is why so few people now receive any risk reduction or treatment. Attending to substance use needs to be brought back into the mainstream of health care, including mental health care.
I am very excited about this next step in my new venture: making scientifically based addiction treatment available to the public in ways that are attractive, accessible, affordable and effective.
There are two major areas of activity. The first is to develop a model for 21st Century specialty addition treatment. Built on a foundation of science, compassion and common sense, the ALLTYR™ Clinic will provide medically based, multidisciplinary evaluation and treatment for the entire spectrum of substance use disorders. The Clinic will use the ASSET™ Model of care. ASSET™ stands for Alcohol and Substance Use Screening, Evaluation and Treatment. We will provide comprehensive evaluations with recommendations for any indicated treatment. The ASSET Clinic will have several areas of specific expertise, including impaired professionals and executives, managing patients with brain injuries, complex chronic pain management, patients with serious medical problems such as cirrhosis and pancreatitis, patients with treatment-resistant alcohol or drug addiction and patients with complex mixes of psychiatric, medical and addictive disorders. The planned opening for the ASSET Clinic is Fall 2011, although we may be able to start accepting patients sooner.
The second focus for ALLTYR will be to help existing healthcare organizations address substance use throughout their system of care. Most people who drink too much or use other psychoactive drugs are not addicted, but are “at-risk” users. That is, they are using at a level that places them at elevated risk for developing problems later. They are currently not symptomatic. For example, someone drinking 4 or 5 drinks several days a week, or using marijuana several times a week, but who does not endorse any criteria for substance dependence. For this group, who do not have a diagnosable disorder, the goal is to counsel them about their use, so as to reduce the risk. They are similar to people with high cholesterol before a heart attack, or high blood pressure before a stroke. Treatment is not appropriate for them. This group is quite responsive to brief counseling, either by health care clinicians or on the internet, by workplace health initiatives, and so forth. When I was at NIH, we developed a product specifically for at-risk drinkers called Rethinking Drinking.
The second group are people who have some symptoms of alcohol addiction (or dependence, these are interchangeable terms) but who are functional. This group primarily endorses symptoms such as repeatedly going over limits, a persistent desire to quit or cut down, and use despite physical or psychological problems caused or exacerbated by their use, such as hangover, nausea, or insomnia. They do not have the kind of problems we usually associate with addiction such as major life disruptions involving employment, parenting, school performance, or serious interpersonal or legal problems. This group, called functional alcohol dependents, are not appropriate for specialty addiction treatment, but respond well to medications and brief support, much like mild to moderate depression is treated in primary care. Both of these groups are best dealt with in non-addiction specialty settings such as primary care or mental health care (general psychiatry).
For these groups, ALLTYR will provide consultation and training for existing health care systems. The goal is to help them address substance use throughout their healthcare system. For too long it has been considered forbidden for anyone but an addiction counselor to address substance use, which is why so few people now receive any risk reduction or treatment. Attending to substance use needs to be brought back into the mainstream of health care, including mental health care.
I am very excited about this next step in my new venture: making scientifically based addiction treatment available to the public in ways that are attractive, accessible, affordable and effective.
Monday, January 24, 2011
A Vaccine Against Addiction?
In this recent post on Science News, more information about a potential cocaine vaccine. You know my view: we need as many tools as possible to fight addiction. Use everything available.
MW
Vaccine against cocaine makes headway
Injections gin up antibodies that limit drug's effects, study in mice showsBy Nathan Seppa Web edition : Thursday, January 20th, 2011
Vaccine against cocaine makes headway
Injections gin up antibodies that limit drug's effects, study in mice showsBy Nathan Seppa Web edition : Thursday, January 20th, 2011 Mice vaccinated against cocaine show less agitated behavior when exposed to the drug than do unvaccinated mice on the drug, as shown by the average time the animals spend on various activities.Crystal et al/Molecular Therapy 2011Antibodies generated by a new vaccine can capture molecules of cocaine in the precious few seconds that lapse before the drug reaches the brain, a study in mice shows. Although the antibody brigade doesn’t snag all the cocaine, it seems to collar enough to greatly subdue the agitation that mice exhibit when given the drug.
Based on these findings, the researchers are moving on to studies in rats and monkeys in hopes of testing the vaccine in people. The new report will appear in the March Molecular Therapy.
“When someone takes cocaine — whether snorted, smoked or injected — you don’t have much time,” says study coauthor Ronald Crystal, a pulmonary physician at Weill Cornell Medical College in New York City. “It takes about six second to pass from the lungs to the blood to the brain.”
A vaccine would need to elicit a standing army poised to intercede. “You need avid antibodies, at high levels,” Crystal says.
In the new study, Crystal and his colleagues gave mice three injections over six weeks. Some of the animals received a placebo while the others got the experimental vaccine, which combines a cocainelike substance with noninfectious portions of an adenovirus that stimulate an immune response but don’t cause disease. Four weeks later, all the mice were exposed to cocaine by injection.
Antibodies elicited by the vaccine kept about three-fifths of the cocaine from reaching the brain in vaccinated animals, according to examinations of the mice, which were given the maximum dose of cocaine. This effect translated into behavioral changes: Cocaine makes mice hyperactive, Crystal says, and in this study the unvaccinated mice were running around much of the time. In contrast, vaccinated mice ran one-third as much and performed repetitive motions half as much, behavior similar to that of mice not given cocaine at all.
Crystal says the vaccine might be ready to test in people in a year or two. “The most obvious strategy is to use it in people who are addicted but who want to stop and have enrolled in a program. This would help them,” he says.
Cocaine dependence accounts for more than one-third of illicit-drug-related emergency room visits, according to the U.S. Drug Abuse Warning Network.
About 40 percent of cocaine users are in denial about their addiction, and another 40 percent are not yet willing to take on the challenge of quitting, says Stephen Ross, an addiction psychiatrist at New York University. “The other 20 percent are ready to make a change,” he says. Such people need behavioral therapy and all available support. “The more tools we have, the better,” Ross says. “A vaccine could be part of that arsenal.” Vaccination might also prevent cocaine addiction in young adults and adolescents who are at high risk, he says.
Any prospective anticocaine vaccine needs a lot of testing, in part because it isn’t clear whether just taking more of the drug might overwhelm a vaccine’s effect, says Frank Orson, a physician and immunologist at the Baylor College of Medicine in Houston. Also, the researchers in the new study used an additive called complete Freund’s adjuvant to boost the immune reponse in the mice. The adjuvant cannot be used in people because of side effects, he says.
Other researchers have sought to build vaccines using adenoviruses, which normally cause the common cold and other ailments, Orson says. These efforts include work on vaccines for HIV, influenza, malaria and other ailments. Adenovirus particles are good at triggering an immune response, he says, which is important for vaccines against addictive drugs because the drugs otherwise go largely unnoticed by immune forces, which are geared up to catch infectious microbes, he says.
Nevertheless, Orson says, “I think there is a good chance we will have vaccines against some of these agents — cocaine being pretty high on the list because of its properties of being fairly short-lived.” Since cocaine is naturally degraded in the blood stream more rapidly than some other illicit drugs, such as methamphetamine, cocaine might make a better target, he says. Orson and his colleagues are currently working on vaccines against cocaine, heroin and methamphetamines.
MW
Vaccine against cocaine makes headway
Injections gin up antibodies that limit drug's effects, study in mice showsBy Nathan Seppa Web edition : Thursday, January 20th, 2011
Vaccine against cocaine makes headway
Injections gin up antibodies that limit drug's effects, study in mice showsBy Nathan Seppa Web edition : Thursday, January 20th, 2011 Mice vaccinated against cocaine show less agitated behavior when exposed to the drug than do unvaccinated mice on the drug, as shown by the average time the animals spend on various activities.Crystal et al/Molecular Therapy 2011Antibodies generated by a new vaccine can capture molecules of cocaine in the precious few seconds that lapse before the drug reaches the brain, a study in mice shows. Although the antibody brigade doesn’t snag all the cocaine, it seems to collar enough to greatly subdue the agitation that mice exhibit when given the drug.
Based on these findings, the researchers are moving on to studies in rats and monkeys in hopes of testing the vaccine in people. The new report will appear in the March Molecular Therapy.
“When someone takes cocaine — whether snorted, smoked or injected — you don’t have much time,” says study coauthor Ronald Crystal, a pulmonary physician at Weill Cornell Medical College in New York City. “It takes about six second to pass from the lungs to the blood to the brain.”
A vaccine would need to elicit a standing army poised to intercede. “You need avid antibodies, at high levels,” Crystal says.
In the new study, Crystal and his colleagues gave mice three injections over six weeks. Some of the animals received a placebo while the others got the experimental vaccine, which combines a cocainelike substance with noninfectious portions of an adenovirus that stimulate an immune response but don’t cause disease. Four weeks later, all the mice were exposed to cocaine by injection.
Antibodies elicited by the vaccine kept about three-fifths of the cocaine from reaching the brain in vaccinated animals, according to examinations of the mice, which were given the maximum dose of cocaine. This effect translated into behavioral changes: Cocaine makes mice hyperactive, Crystal says, and in this study the unvaccinated mice were running around much of the time. In contrast, vaccinated mice ran one-third as much and performed repetitive motions half as much, behavior similar to that of mice not given cocaine at all.
Crystal says the vaccine might be ready to test in people in a year or two. “The most obvious strategy is to use it in people who are addicted but who want to stop and have enrolled in a program. This would help them,” he says.
Cocaine dependence accounts for more than one-third of illicit-drug-related emergency room visits, according to the U.S. Drug Abuse Warning Network.
About 40 percent of cocaine users are in denial about their addiction, and another 40 percent are not yet willing to take on the challenge of quitting, says Stephen Ross, an addiction psychiatrist at New York University. “The other 20 percent are ready to make a change,” he says. Such people need behavioral therapy and all available support. “The more tools we have, the better,” Ross says. “A vaccine could be part of that arsenal.” Vaccination might also prevent cocaine addiction in young adults and adolescents who are at high risk, he says.
Any prospective anticocaine vaccine needs a lot of testing, in part because it isn’t clear whether just taking more of the drug might overwhelm a vaccine’s effect, says Frank Orson, a physician and immunologist at the Baylor College of Medicine in Houston. Also, the researchers in the new study used an additive called complete Freund’s adjuvant to boost the immune reponse in the mice. The adjuvant cannot be used in people because of side effects, he says.
Other researchers have sought to build vaccines using adenoviruses, which normally cause the common cold and other ailments, Orson says. These efforts include work on vaccines for HIV, influenza, malaria and other ailments. Adenovirus particles are good at triggering an immune response, he says, which is important for vaccines against addictive drugs because the drugs otherwise go largely unnoticed by immune forces, which are geared up to catch infectious microbes, he says.
Nevertheless, Orson says, “I think there is a good chance we will have vaccines against some of these agents — cocaine being pretty high on the list because of its properties of being fairly short-lived.” Since cocaine is naturally degraded in the blood stream more rapidly than some other illicit drugs, such as methamphetamine, cocaine might make a better target, he says. Orson and his colleagues are currently working on vaccines against cocaine, heroin and methamphetamines.
Two recent presentations available on the web
Colleagues and friends,
After a prolonged absence from the blog due to holidays and the press of other business, I'll be now keeping up with the blog again. I now have a site for posting my presentations, and I recently uploaded two of my most recent slide sets. I'll be posting additional ones as they are developed. The URL is https://show.zoho.com/public/mwillenbring.
Much has happened in the past 3 months. I have incorporated a new company, ALLTYR, Inc. ALLTYR is dedicated to transforming treatment for addictions through multiple activities. My goal is to open a clinic, the ASSET Clinic, in the Twin Cities in the fall of 2011. The ASSET Clinic will be a model for providing scientifically informed specialty treatment for addictions and will serve as a prototype, laboratory and clinical teaching site. The Clinic will provide the full array of services for all degrees of substance involvement and for as long as needed. It is not a "program," but will function like any other professional specialty clinic. A key focus will be on customer service. ALLTYR will also provide consultation to existing healthcare systems to help them integrate attention to substance use throughout their organization, especially in primary care, mental health care, the ed, and inpatient services. ALLTYR will provide materials, training, technical support, and will also offer the opportunity to either operate or develop an ASSET Specialty Clinic within existing health care organizations (HCOs). Much more on this later as it develops.
MW
After a prolonged absence from the blog due to holidays and the press of other business, I'll be now keeping up with the blog again. I now have a site for posting my presentations, and I recently uploaded two of my most recent slide sets. I'll be posting additional ones as they are developed. The URL is https://show.zoho.com/public/mwillenbring.
Much has happened in the past 3 months. I have incorporated a new company, ALLTYR, Inc. ALLTYR is dedicated to transforming treatment for addictions through multiple activities. My goal is to open a clinic, the ASSET Clinic, in the Twin Cities in the fall of 2011. The ASSET Clinic will be a model for providing scientifically informed specialty treatment for addictions and will serve as a prototype, laboratory and clinical teaching site. The Clinic will provide the full array of services for all degrees of substance involvement and for as long as needed. It is not a "program," but will function like any other professional specialty clinic. A key focus will be on customer service. ALLTYR will also provide consultation to existing healthcare systems to help them integrate attention to substance use throughout their organization, especially in primary care, mental health care, the ed, and inpatient services. ALLTYR will provide materials, training, technical support, and will also offer the opportunity to either operate or develop an ASSET Specialty Clinic within existing health care organizations (HCOs). Much more on this later as it develops.
MW
Tuesday, November 9, 2010
Abstinence based treatment for opioid addiction kills people
So how can abstinence based programs not inform patients about these studies and the alternatives to abstinence? In any other branch of medicine this is called negligence and the Supreme Court has clearly ruled that to not inform a patient of alternative therapies and relative rates of recovery is unethical and negligent practice. Why do state licensing agencies allow this to happen? As noted below, although this new study adds to the literature, many other studies have shown reduced mortality from maintenance as opposed to either detox, stabilize and taper or simply abstinence-based treatments. In my view, programs that are based on an ideological belief in abstinence but who do not inform patients of the relative risks, benefits and likelihood of recovery are risking a lawsuit because they are not providing basic informed consent for patients and families.
MW
From Medscape Medical News
Opiate Replacement Treatment Reduces Mortality in Addicted Patients
Deborah Brauser
October 29, 2010 — Year-long treatment with either buprenorphine or methadone can substantially decrease the number of drug-related deaths in opiate misusers, suggests new findings from British researchers.
In fact, results from this large cohort study showed that patients given "opiate substitution treatment" for 12 months or more had a greater than 85% reduced overall mortality risk.
"This treatment reduces the risk of death — but treatment duration matters," investigative team member Matt Hickman, professor in public health and epidemiology at the School of Social and Community Medicine at the University of Bristol in the United Kingdom, told Medscape Medical News.
In addition, the investigators write that "closer supervision is needed" because significant mortality risks were found for these patients during both the first 28 days after beginning and the first month after ending treatment compared with other times.
"We found that the risk of death in the first month leaving...was about 4 times higher than rest of time off treatment, which is very similar to difference in risk of death after leaving prison," said Professor Hickman.
The investigators write that although "the difference in mortality between opiate users in and out of treatment is stark and well known," few studies have looked at this risk at specific time points.
"We hypothesize that the raised risk of death in the first month of treatment and especially in the month after the end of treatment may negate any protective effect of opiate substitution treatment, unless treatment is prolonged," they add.
The study was published online October 27 in the British Medical Journal.
Opiate Use Continues to Increase
For opiate users, "systematic reviews estimate annual death rates of about 1%, which is more than 10 times that of the general population and contributes more than 10% of adult mortality," write the study authors. Most of these deaths are due to overdose.
"Estimates of the prevalence of opiate use in the UK suggest 30-fold increases between 1970 and 2000, but more recent estimates are stable at around 250,000 opiate users," they add, noting that opiate substitution therapy in their country is given mainly within primary care.
For this study, the investigators pulled information from the United Kingdom's General Practice Research Database. They then evaluated data on 5577 primary care patients between the ages of 16 and 59 years (58% younger than 30 at start of treatment, 69% male) diagnosed as having "substance misuse" and prescribed noninjectible methadone or buprenorphine between 1990 and 2005.
A total of 267,003 prescriptions were written for these patients. A total of 57% of the patients were prescribed methadone only; 19% were prescribed methadone and dihydrocodeine; 9% were prescribed methadone and buprenorphine; 8% were prescribed buprenorphine only; 4% were prescribed buprenorphine and dihydrocodeine; and 4% were prescribed methadone, buprenorphine, and dihydrocodeine.
All patients were followed up "until 1 year after the expiry of their last prescription, the date of death before this time had elapsed, or the date of transfer away from the practice," report the investigators. The median length of follow-up was 2 years.
The main outcome measure was all-cause mortality. Secondary measures included risk for death at different periods during and after treatment.
They also estimated "the probability that opiate substitution treatment reduces average mortality for patients exposed to different durations of treatment compared with if they had been unexposed."
Mortality Doubled When Not Receiving Treatment
Results of the analysis showed that 178 of the patients died (62 while undergoing treatment, 116 within 1 year of their last prescription).
The overall crude mortality rates were 0.7 per 100 person-years while receiving opiate replacement treatment and 1.3 while not receiving treatment.
"The crude mortality rate off treatment was almost double that on treatment, and after adjustment (for age, sex, calendar period, and comorbidity) the mortality rate ratio was more than twice as high" (2.3; 95% confidence interval [CI], 1.7 – 3.1), write the investigators.
Standardized mortality ratios, "comparing death rates among study patients with the population of England and Wales," were 5.3 (95% CI, 4.0 – 6.8) while undergoing treatment and 10.9 (95% CI, 9.0 –13.1) while not undergoing treatment.
In addition, men using opiates almost doubled the risk for death of women users (mortality rate ratio, 1.97; 95% CI, 1.4 – 2.9). However, the standardized mortality ratios were similar between men and women when both receiving and not receiving treatment.
Also, "mortality increased with age and was positively associated with comorbidity score," report the researchers.
When looking at treatment duration, the crude mortality rate was highest during the first 2 weeks at 1.7 per 100 person-years. After adjustment, this was 3.1 (95% CI, 1.5 – 6.6) times higher than the rate during the remainder of time receiving treatment.
The crude mortality rate during weeks 3 and 4 of treatment was 1.3, and the adjusted mortality rate ratio was 2.4 (95% CI, 0.95 – 6.0).
The mortality rates and ratios during the first month after stopping treatment were even higher:
Table. Mortality Rates and Ratios
Time Not Receiving Treatment Crude MR Adjusted MR Ratio (95% CI)
1-2 weeks 4.8 9.0 (5.4 – 14.9)
3-4 weeks 4.3 8.0 (4.7 – 13.7)
Remainder of time 0.95 1.9 (1.3 – 2.8)
CI = confidence interval; MR = mortality rate
"We found no evidence of any difference in the risk of death between buprenorphine and methadone when we compared the whole period on and off treatment," the study authors write.
Finally, short treatment durations of between 20 to 30 weeks reduced the overall risk for death by less than 25%. However, that rate increased to 65% at 40 weeks' duration and to more than 85% at durations "approaching or exceeding a year.
"The overall risk of death, standardized mortality ratios, and overall difference in mortality between time on and off treatment for opiate users in UK primary care in this study are consistent with international literature," report the investigators.
"Further research is needed to investigate the effect of average duration of opiate substitution treatment on drug related mortality," they write.
"We hope that others also will examine further what interventions might reduce risk of relapse following treatment," added Professor Hickman.
Twice as Likely to Live If in Treatment
"This study is based on the British concepts of treatment, which are different from the US," Mary Jeanne Kreek, MD, professor and head of the Laboratory of the Biology of Addictive Diseases at Rockefeller University in New York City, told Medscape Medical News.
"They simply took all comers over a protracted period of 15 years who were labeled as receiving prescriptions for opiate substitution treatment. So their data will not look like US, Swedish, Norwegian data. Any place where they carefully follow up their people with more oversight," said Dr. Kreek.
She said that the British do not have tight control regarding this treatment "because individual doctors can do the prescribing."
Also, she noted that the word "substitution" is not used in the United States. "That's not allowed. Instead, we call it 'replacement treatment' or simply 'maintenance treatment.'"
Dr. Kreek, who was not involved with this study, has served on the National Institute on Drug Abuse National Advisory Council and is a past president of the College on Problems of Drug Dependence.
She said that "the most important result" from this study is the substantial crude mortality rate difference between people receiving and not receiving treatment. "That's the critical thing."
However, this finding isn't new. Dr. Kreek noted that Dr. Lars Gunne wrote that heroin addicts untreated had a death rate that was "multifold higher, based on a randomized study of methadone treatment in Sweden in the late 70s" (Drug Alcohol Depend. 1981;7:249-256).
She also noted that "there isn't really an end-of-treatment phase" for these types of patients in the United States.
"There is only about 5% to 10% who've been successfully treated and request to have their medication dose reduced and eliminated," said Dr. Kreek. "To take people off treatment is, to us, unethical unless they really ask and will work with you as a care provider to be followed up in a medication-free state.
"So why are these people [in this study] coming off treatment? The [investigators] don't really get into that, but in Britain there is more of a casual entry to and exit from treatment."
Another big difference is that "we've never seen a death in this country at the induction of this treatment," reported Dr. Kreek. "With buprenorphine, we don't watch people, but we have a very tight induction schedule that's well regulated, starting low and going on up."
Overall, Dr. Kreek said that this study is interesting to look at but "isn't really relevant to US practice" — except for the crude mortality rate difference.
"It doesn't matter what kind of program you have, people are twice as apt to live if they're in treatment than if they're not in treatment. That's what's important. Methadone and buprenorphine both can be very effective if properly used," she summarized.
This study was funded in part by a grant from the National Institute of Health Research (NIHR) for the Center for Research on Drugs and Health Behavior, a career scientist fellowship award from the NIHR, and an Medical Research Council new investigator award. The study authors and Dr. Kreek have disclosed no relevant financial relationships.
BMJ. Published online October 27, 2010.
MW
From Medscape Medical News
Opiate Replacement Treatment Reduces Mortality in Addicted Patients
Deborah Brauser
October 29, 2010 — Year-long treatment with either buprenorphine or methadone can substantially decrease the number of drug-related deaths in opiate misusers, suggests new findings from British researchers.
In fact, results from this large cohort study showed that patients given "opiate substitution treatment" for 12 months or more had a greater than 85% reduced overall mortality risk.
"This treatment reduces the risk of death — but treatment duration matters," investigative team member Matt Hickman, professor in public health and epidemiology at the School of Social and Community Medicine at the University of Bristol in the United Kingdom, told Medscape Medical News.
In addition, the investigators write that "closer supervision is needed" because significant mortality risks were found for these patients during both the first 28 days after beginning and the first month after ending treatment compared with other times.
"We found that the risk of death in the first month leaving...was about 4 times higher than rest of time off treatment, which is very similar to difference in risk of death after leaving prison," said Professor Hickman.
The investigators write that although "the difference in mortality between opiate users in and out of treatment is stark and well known," few studies have looked at this risk at specific time points.
"We hypothesize that the raised risk of death in the first month of treatment and especially in the month after the end of treatment may negate any protective effect of opiate substitution treatment, unless treatment is prolonged," they add.
The study was published online October 27 in the British Medical Journal.
Opiate Use Continues to Increase
For opiate users, "systematic reviews estimate annual death rates of about 1%, which is more than 10 times that of the general population and contributes more than 10% of adult mortality," write the study authors. Most of these deaths are due to overdose.
"Estimates of the prevalence of opiate use in the UK suggest 30-fold increases between 1970 and 2000, but more recent estimates are stable at around 250,000 opiate users," they add, noting that opiate substitution therapy in their country is given mainly within primary care.
For this study, the investigators pulled information from the United Kingdom's General Practice Research Database. They then evaluated data on 5577 primary care patients between the ages of 16 and 59 years (58% younger than 30 at start of treatment, 69% male) diagnosed as having "substance misuse" and prescribed noninjectible methadone or buprenorphine between 1990 and 2005.
A total of 267,003 prescriptions were written for these patients. A total of 57% of the patients were prescribed methadone only; 19% were prescribed methadone and dihydrocodeine; 9% were prescribed methadone and buprenorphine; 8% were prescribed buprenorphine only; 4% were prescribed buprenorphine and dihydrocodeine; and 4% were prescribed methadone, buprenorphine, and dihydrocodeine.
All patients were followed up "until 1 year after the expiry of their last prescription, the date of death before this time had elapsed, or the date of transfer away from the practice," report the investigators. The median length of follow-up was 2 years.
The main outcome measure was all-cause mortality. Secondary measures included risk for death at different periods during and after treatment.
They also estimated "the probability that opiate substitution treatment reduces average mortality for patients exposed to different durations of treatment compared with if they had been unexposed."
Mortality Doubled When Not Receiving Treatment
Results of the analysis showed that 178 of the patients died (62 while undergoing treatment, 116 within 1 year of their last prescription).
The overall crude mortality rates were 0.7 per 100 person-years while receiving opiate replacement treatment and 1.3 while not receiving treatment.
"The crude mortality rate off treatment was almost double that on treatment, and after adjustment (for age, sex, calendar period, and comorbidity) the mortality rate ratio was more than twice as high" (2.3; 95% confidence interval [CI], 1.7 – 3.1), write the investigators.
Standardized mortality ratios, "comparing death rates among study patients with the population of England and Wales," were 5.3 (95% CI, 4.0 – 6.8) while undergoing treatment and 10.9 (95% CI, 9.0 –13.1) while not undergoing treatment.
In addition, men using opiates almost doubled the risk for death of women users (mortality rate ratio, 1.97; 95% CI, 1.4 – 2.9). However, the standardized mortality ratios were similar between men and women when both receiving and not receiving treatment.
Also, "mortality increased with age and was positively associated with comorbidity score," report the researchers.
When looking at treatment duration, the crude mortality rate was highest during the first 2 weeks at 1.7 per 100 person-years. After adjustment, this was 3.1 (95% CI, 1.5 – 6.6) times higher than the rate during the remainder of time receiving treatment.
The crude mortality rate during weeks 3 and 4 of treatment was 1.3, and the adjusted mortality rate ratio was 2.4 (95% CI, 0.95 – 6.0).
The mortality rates and ratios during the first month after stopping treatment were even higher:
Table. Mortality Rates and Ratios
Time Not Receiving Treatment Crude MR Adjusted MR Ratio (95% CI)
1-2 weeks 4.8 9.0 (5.4 – 14.9)
3-4 weeks 4.3 8.0 (4.7 – 13.7)
Remainder of time 0.95 1.9 (1.3 – 2.8)
CI = confidence interval; MR = mortality rate
"We found no evidence of any difference in the risk of death between buprenorphine and methadone when we compared the whole period on and off treatment," the study authors write.
Finally, short treatment durations of between 20 to 30 weeks reduced the overall risk for death by less than 25%. However, that rate increased to 65% at 40 weeks' duration and to more than 85% at durations "approaching or exceeding a year.
"The overall risk of death, standardized mortality ratios, and overall difference in mortality between time on and off treatment for opiate users in UK primary care in this study are consistent with international literature," report the investigators.
"Further research is needed to investigate the effect of average duration of opiate substitution treatment on drug related mortality," they write.
"We hope that others also will examine further what interventions might reduce risk of relapse following treatment," added Professor Hickman.
Twice as Likely to Live If in Treatment
"This study is based on the British concepts of treatment, which are different from the US," Mary Jeanne Kreek, MD, professor and head of the Laboratory of the Biology of Addictive Diseases at Rockefeller University in New York City, told Medscape Medical News.
"They simply took all comers over a protracted period of 15 years who were labeled as receiving prescriptions for opiate substitution treatment. So their data will not look like US, Swedish, Norwegian data. Any place where they carefully follow up their people with more oversight," said Dr. Kreek.
She said that the British do not have tight control regarding this treatment "because individual doctors can do the prescribing."
Also, she noted that the word "substitution" is not used in the United States. "That's not allowed. Instead, we call it 'replacement treatment' or simply 'maintenance treatment.'"
Dr. Kreek, who was not involved with this study, has served on the National Institute on Drug Abuse National Advisory Council and is a past president of the College on Problems of Drug Dependence.
She said that "the most important result" from this study is the substantial crude mortality rate difference between people receiving and not receiving treatment. "That's the critical thing."
However, this finding isn't new. Dr. Kreek noted that Dr. Lars Gunne wrote that heroin addicts untreated had a death rate that was "multifold higher, based on a randomized study of methadone treatment in Sweden in the late 70s" (Drug Alcohol Depend. 1981;7:249-256).
She also noted that "there isn't really an end-of-treatment phase" for these types of patients in the United States.
"There is only about 5% to 10% who've been successfully treated and request to have their medication dose reduced and eliminated," said Dr. Kreek. "To take people off treatment is, to us, unethical unless they really ask and will work with you as a care provider to be followed up in a medication-free state.
"So why are these people [in this study] coming off treatment? The [investigators] don't really get into that, but in Britain there is more of a casual entry to and exit from treatment."
Another big difference is that "we've never seen a death in this country at the induction of this treatment," reported Dr. Kreek. "With buprenorphine, we don't watch people, but we have a very tight induction schedule that's well regulated, starting low and going on up."
Overall, Dr. Kreek said that this study is interesting to look at but "isn't really relevant to US practice" — except for the crude mortality rate difference.
"It doesn't matter what kind of program you have, people are twice as apt to live if they're in treatment than if they're not in treatment. That's what's important. Methadone and buprenorphine both can be very effective if properly used," she summarized.
This study was funded in part by a grant from the National Institute of Health Research (NIHR) for the Center for Research on Drugs and Health Behavior, a career scientist fellowship award from the NIHR, and an Medical Research Council new investigator award. The study authors and Dr. Kreek have disclosed no relevant financial relationships.
BMJ. Published online October 27, 2010.
Subscribe to:
Posts (Atom)