Deaths of Despair at Highest Levels Ever!

From the Well Being Trust:

Far too many Americans are dying from preventable causes, and each time we make progress it seems like new problems appear. Take the case of opioid overdoses. As we are beginning to get a handle on misuse of prescription opioids, fentanyl and synthetic opioids have come to the fore. Two decades ago, they were linked to fewer than 1,000 deaths each year. In 2017, fentanyl and synthetic opioids killed more than 28,000 Americans.

The emphasis on opioids is appropriate, but too narrow. The underlying conditions that often lead to drug misuse can also lead to alcohol misuse, loneliness, and despair. Even as America is experiencing surging rates of drug misuse, the nation is also witnessing an unprecedented rate of suicide deaths, which rose 6 percent between 2016 and 2017, and with alarming increases among children and adolescents.

Overall, more than 150,000 Americans — the most ever — died from alcohol and drug-induced fatalities and suicide in 2017. That’s more than twice as many as in 1999, according to a new analysis released on Tuesday by our organizations, Well Being Trust and Trust for America’s Health.

To truly tackle complex, deeply rooted societal problems like these, we need to transform fragmented and disjointed community systems. Deaths from substance misuse and suicide are symptoms of broader problems. If we treat only the symptoms, more and more people will be at risk and die needlessly.

Related:

A national resilience strategy can help prevent deaths from despair

To address the underlying causes, we need a comprehensive approach that includes increasing funding and support for programs that reduce risk factors for despair and promote resilience in children, families, and communities. Exposure to trauma and adverse life experiences at young ages increases the potential for substance misuse and suicide. Programs that reduce community violence; address poverty and discrimination; create safe, supportive schools and quality learning experiences; and promote access to secure housing and employment opportunities can decrease adverse experiences and build resilience.
For example, the Nurse-Family Partnership works with young, low-income women who are pregnant for the first time. A public health nurse meets with the mother from pregnancy until the child turns 2, establishing a trusted relationship with both. The home visits connect first-time mothers with the care and support they need to ensure a healthy pregnancy and birth. The model has been shown to have dramatic benefits to society. For instance, when Medicaid pays for Nurse-Family Partnership services, the federal government gets a 54 percent return on its investment.
Along that line, the nation should expand substance misuse prevention and mental health programs in schools by increasing the number of schools that get training for, can screen for, and can respond to childhood trauma. Schools should also be supported in scaling up evidence-based life- and coping-skills programs like the Good Behavior Game, and increasing the availability of culturally appropriate mental health and other services.
Schools should also work with other community agencies to assist the families of the children who have experienced trauma. Successful school substance misuse prevention programs return $3.80 to $34 for every $1 invested; social-emotional learning programs provide an $11 for $1 return; and school violence prevention programs (including suicide) have a $15 to $81 return.
The nation will see results only if it addresses the need for a multigenerational response that includes substance use disorder treatment for parents and additional support for all caregivers while also expanding resources for the foster care system.
Model programs have been effective in helping mothers achieve sobriety, reducing state custody placement of children by half and producing a strong return on investment. Sobriety Treatment and Recovery Teams (START), for example, is a Kentucky-based program for families with parental substance use disorders and issues of child abuse and/or neglect. It helps parents achieve sobriety and, when possible, keeps children safely with their parents. Mothers who participated in START achieved sobriety at nearly twice the rate of those not in the program and children in START families were half as likely to be placed in state custody. For every dollar spent on START, Kentucky avoided spending $2.22 on foster care.

Doctors: CDC Guidelines Are Hurting Pain Patients

From the Washington Post, March 6, 2019:

Health-care providers say CDC’s opioid guidelines are harming pain patients

By Lenny Bernstein

March 6, 2019 at 8:20 PM

More than 300 health-care experts told the Centers for Disease Control and Prevention Wednesday that the agency’s landmark guidelines for the use of opioids against chronic pain are harming patients who suffer from long-term pain and benefit from the prescription narcotics.

The health-care providers, including three former U.S. drug czars, said the CDC recommendation of a daily numerical threshold for opioid use has led insurers to refuse reimbursement, pharmacies to erect obstacles to obtaining drugs and risks for doctors who want to give out more.

“Taken in combination, these actions have led many health care providers to perceive a significant category of vulnerable patients as institutional and professional liabilities to be contained or eliminated, rather than as people needing care,” they said in a letter to the agency.

They said patients have endured unnecessary pain, turned to illegal drugs and even committed suicide.

The role of opioids for chronic pain has been one of the most contested aspects of the nationwide crackdown on narcotic prescribing. The CDC guidelines, issued in 2016, assert there is little evidence for the use of opioids against pain beyond 12 weeks.

But many patients have claimed that long-term use of the drugs is all that stands between them and unrelenting pain, and that they can take the medication without becoming dependent or addicted. The accumulation of that anecdotal evidence led to the experts, who call themselves Health Professionals for Patients in Pain, to write to the CDC.

The CDC did not respond to a request for comment Wednesday.

The National Institutes of Health is studying the issue as part of its Helping to End Addiction Long-term Initiative and last week the Food and Drug Administration ordered drug companies to examine whether opioids are effective against chronic pain.

In the meantime, the number of opioid prescriptions issued annually has fallen sharply, from a peak of more than 255 million in 2012 to 191 million in 2017, according to the CDC. Many states have enacted limits on opioid prescribing.

Still, 47,600 people died of opioid overdoses in 2017, more than 17,000 of them from legal painkillers such as oxycodone, hydrocodone and methadone.

The CDC guidelines suggest 90 milligrams of morphine or their equivalent as a daily ceiling for opioid use against pain. But the letter said insurers, regulators and others have used the figure “as both a professional standard and a threshold for professional suspicion.”

The group called on the CDC to investigate the damage that the limit may be doing to patients and to clarify the guidelines, especially in regard to discontinuing patients’ opioid use.

New USPTF Guidelines on Prevention of Perinatal Depression

The US Prevention Task Force has issued a new guideline for prevention of perinatal depression, and it's surprising how easy it is. A few sessions of CBT or interpersonal therapy, usually initiated in the second trimester, significantly reduced the incidence of perinatal depression. The Task Force went on to stated that it had moderate confidence that if this were widely implemented, it could provide a substantial public benefit. It's important the this was done preventively, before depression was established. It should be done in high risk groups: women with a history of depression, subsyndromal symptoms of depression, and women in certain groups. These include low socio-economic status, adolescent or single parenthood, recent partner violence, elevated levels of anxiety or a history of negative life events. Insufficient or mixed evidence was found for other potential interventions, including exercise, dietary supplements, pharmacotherapy, and health systems interventions. The group concluded that physicians should provide counseling or refer pregnant women in these high-risk groups for counseling.

Small Study Suggests That Naltrexone Blockade Dose Not Block Ketamine Response

A small study at Yale demonstrated that treatment with naltrexone, an opioid-blocking agent used to treat alcohol use disorder, does not interfere with an antidepressant response to ketamine. Yoon, et al. followed 5 subjects being treated with naltrexone as they received ketamine infusions for depression. Three of five subjects showed remission, and 5/5 showed response. (See figure for details.)

This study contradicts an earlier one that showed no ketamine response for people under naltrexone blockage. More to come, I'm sure.

Recent data on opioids from the CDC

Study Shows Urban-Rural Split on Opioid Prescribing Rates; Putting the Numbers to Fentanyl Deaths in NYC

A new study just released from the CDC confirmed findings that opioid prescriptions were nearly twice as likely to occur among rural residents, compared to central metro areas. (García MC, Heilig CM, Lee SH, et al. Opioid Prescribing Rates in Nonmetropolitan and Metropolitan Counties Among Primary Care Providers Using an Electronic Health Record System — United States, 2014–2017. MMWR Morb Mortal Wkly Rep 2019;68:25–30. DOI: http://dx.doi.org/10.15585/mmwr.mm6802a1.)  The study analyzed data from the AthenaHealth electronic medical record system. This cloud based EMR is used by about 100,000 providers serving 86 million patients. De-identified data were used for the study.

The first take-home message is that there is a lot of opioid prescriptions flying out of rural providers’ offices. At the last data point in 2017, about 9% of patients in non-core and micropolitan areas, whereas only 5% received a prescription in central metropolitan areas.

A second major finding was that the percentage of patients in metro areas remained remarkably stable, at 5%, whereas in rural areas, it got as high as 10.3%, before starting to drop since 2016. 

The authors correctly point out that there are many possible reasons for such a finding. However, the split between rural and urban areas is solid.

In another article from the same issue (Colon-Berezin C, Nolan ML, Blachman-Forshay J, Paone D. Overdose Deaths Involving Fentanyl and Fentanyl Analogs — New York City, 2000–2017. MMWR Morb Mortal Wkly Rep 2019;68:37–40. DOI: http://dx.doi.org/10.15585/mmwr.mm6802a3,) deaths from fentanyl overdose increased dramatically. In 2012, about 2% of deaths involved fentanyl, but by 2017, fentanyl involvement was present in 57% of overdose deaths in New York City.

The CDC's Morbidity and Mortality Weekly is available to all here. 

Good New About American Teens!

HealthDay

More U.S. Teens Shunning Drugs, Alcohol

By  Alan Mozes

HealthDay Reporter

THURSDAY, July 19, 2018 (HealthDay News) -- Over the last four decades, more American teenagers have decided to say no to drugs and alcohol, a new report shows.

"There has been a steady increase in the proportion of students graduating high school who report never having tried alcohol, marijuana, tobacco or any other drugs," said study author Dr. Sharon Levy. She directs the adolescent substance use and addiction program at Boston Children's Hospital.

For example, while about 5 percent of high school seniors had embraced abstinence in 1976, that figure had risen to 25 percent in 2014, according to the most recent poll of nearly 12,000 students.

Surveys conducted among 8th and 10th graders between 1991 and 2014 unearthed a similar trend, with abstinence jumping from roughly 10 percent to almost 40 percent among the former, and from 25 percent to more than 60 percent among the latter.

There was also a jump in total abstinence during the month leading up to each survey, rising from just over 20 percent among high school seniors in 1976 to more than 50 percent by 2014. Among 8th graders, that jump was from about 50 to about 65 percent, while among 10th graders month-long abstinence rose from about 65 to roughly 85 percent, the findings showed.

Levy said the downward trends didn't catch her off-guard, even if "the findings may surprise people because we constantly hear bad news about drug use and the opioid epidemic."

She explained that both drinking and smoking -- the number one and number three most common substance use habits -- have been sliding in popularity across the board for a while now, even though pot use has held steady.

But why? That remains "the million dollar question," said Levy, "and for sure it doesn't have one simple answer."

Overall, she credited public health efforts for giving rise to a new cultural climate that encourages teens to shun substance use because it's dangerous and unhealthy, rather than because it's immoral or forbidden.

Dr. Eric Sigel, an adolescent medicine specialist at Children's Hospital Colorado in Aurora, said the results of those efforts are "encouraging."

Sigel, who was not part of the study team, attributed the trend to successful grassroots campaigns such as Mothers Against Drunk Driving (MADD), the increased availability of mental health and substance use programs, better parental role-modeling and an emphasis on the harsh health risks posed, particularly by cigarettes.

Still, Levy warned that the good news "is quite precarious."

For example, "while fewer teens overall are using substances, those who do face a landscape of more dangerous substances [like opioids] compared to their parents' generation," Levy said.

Investigators also found that white and Hispanic teens were less likely to choose abstinence, compared with their black peers. And because girls are more likely than boys to "misuse" prescription drugs -- particularly pain medications -- they were also less likely to be fully abstinent, despite less frequent alcohol, marijuana and tobacco use.

"This is a good reminder that parents, primary care providers and other trusted adults should be talking to kids about avoiding prescription medications, knowing how addictive they can be," Levy said.

What's more, she stressed that "there are always lurking threats to our progress." In particular, Levy pointed to the soaring popularity of e-cigarettes and the steadfast appeal of marijuana, both of which are increasingly perceived as safe.

Those threats were also highlighted by Sigel.

"Society has not as yet focused those [education] efforts on marijuana being detrimental to youth," he said. "Nor have we had the opportunity to combat the whole vaping/electronic use of tobacco products."

Both habits are on the rise, Sigel said, a "foreboding" development that "could influence these [abstinence] trends for years to come."

The study findings were published online July 19 in the journal Pediatrics. http://pediatrics.aappublications.org/content/early/2018/07/17/peds.2017-3498

More information

There's more on substance use and teens at the U.S. National Institute on Drug Abuse.

SOURCES: Sharon Levy, M.D., MPH, director, adolescent substance use and addiction program, division of developmental medicine, Boston Children's Hospital; Eric Sigel, M.D., adolescent medicine specialist, Children's Hospital Colorado, Aurora; July 19, 2018, Pediatrics, online

Opening in Los Angeles!

Opening in California!

I’m pleased to announce the opening of Alltyr Addiction and Mental Health Services in Los Angeles, CA! In order to establish a footprint there, we’ve rented an office at 10886 Wilshire Blvd, Los Angeles, CA 90024. It’s on the corner of Wilshire and Westwood, near UCLA.

I’ll be coming out for the first time next week. I’ll be arriving Thursday night, and I’ll be in the office all day Friday and possibly Sat AM. Phone number is the same. I’ll be out monthly at first, and do the rest via telehealth. As business picks up, I’ll be coming out more often and/or for longer time periods.

I’m really looking forward to bringing Alltyr’s brand of 21st Century addiction and mental health treatment to California!

Mark

More Evidence Chantix May Reduce Heavy Drinking(*)

A newly published study suggests varenicline (Chantix) may have role in the treatment of co-occurring alcohol use disorder and smoking.  Results from the Phase 2, randomized placebo-controlled trial, published in last month's JAMA Psychiatry, showed a reduction in the percentage of heavy drinking days among some of its participants.  These results, however, came with a big asterisk: the improvements were only seen among the men enrolled in the study, while the women in the placebo group showed more improvement than those in the medication group.

Chantix has been FDA-approved for smoking cessation since 2006.  As a partial nicotinic acetylcholine receptor agonist, it has been called the "Suboxone of nicotine addiction."  As researchers gained insights into the converging role this receptor system plays in both smoking and alcohol reward, the idea that it could have value in alcohol use disorder (AUD) treatment gained momentum.  Preclinical studies in 2007, 2009, and 2011 showed some promising results, indicating rodents taking the medicine drank less alcohol than those who weren't.  This led to several small human trials of Chantix for heavy drinking, though with mixed results.  The February study was the first to show such divergent results between the two genders, and it is unclear why men fared so much better than the women enrolled in the study.

Nevertheless, these results contribute a little more data to the search for new addiction medications and suggest prescribers may want to consider Chantix for their male patients who both smoke and drink heavily.  Here at Alltyr Clinic, we have seen some of our AUD patients respond quite well to Chantix.  Since our clinicians routinely screen our patients who smoke for their desire to quit, it has been a logical option to consider as a firstline treatment. Despite the less-than-blockbuster results of this study, we are glad to hear about any new research on potential medication options.

See the study here:
https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2665215?redirect=true

And the earlier trial can be seen here:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3914416/ 

Researchers: Supervised Methadone and Buprenorphine Dosing Adds Little Therapeutic Benefit

Methadone, the full agonist synthetic opioid, is one of the most tightly regulated medications on the planet - at least, that is, when it's being used to treat opioid addiction.  Here in Minnesota, no fewer than 5 regulatory bodies oversee the clinics that provide methadone maintenance treatment (MMT).  One of the core federal requirements of "opiate treatment programs" is daily supervised dosing, requiring patients to come daily to the clinic to receive their dose, observed by trained nursing staff for at least the first 3 months.  After that, patients earn one additional day of "take-home" doses at a time until they've earned 1 week (after the 8th month of treatment), then 2 weeks (after the first year in treatment), and finally 4 weeks of take-home doses (after 2 years of sustained participation in the program).  The rationale for these highly restrictive federal rules, ostensibly, has been that it will protect patient safety, decrease diversion, and will improve outcomes among MMT patients.

A recent review of the literature throws these assumptions into question.  The review, analyzed and shared by the folks at Drug and Alcohol Findings, found "no evidence that supervising consumption meant patients were better safeguarded or that the treatment more effectively reduced illegal drug use."  Instead, these policies tend to be quite costly to programs and burdensome to patients.  They reinforce negative stereotypes about MMT patients and have prevented people from seeking potentially lifesaving treatment. 

Here at Alltyr Clinic, we routinely hear from patients that the ability to receive a monthly prescription of Suboxone has meant they could keep their job or maintain their role within the family.  With all the national attention being given to the recent spike in overdose statistics, maybe it's time the feds re-visit these burdensome regulations and increase access to the highly effective treatments. 

From the Findings UK article:

Supervised dosing with a long-acting opioid medication in the management of opioid dependence
http://findings.org.uk/PHP/dl.php?file=Saulle_R_1.txt&s=eb&sf=sfnos

Key points
From summary and commentary

Guidelines recommend making opioid-dependent patients take their methadone or other opioid substitutes at the clinic or pharmacy to safeguard the patient and prevent medication being ‘diverted’ to other people.

Randomised trials and studies study which monitored patients in routine treatment afforded no evidence that supervising consumption meant patients were better safeguarded or that the treatment more effectively reduced illegal drug use.

However, introduction of supervision to UK treatment services was associated with fewer methadone-related overdose deaths.

Findings and expert opinion support initial supervised consumption and its relaxation on an individual basis, depending on assessment of the patient.

The Language We Use in Addiction Treatment

The language we use related to alcohol and drug use disorders is often stigmatizing and misguided. Alltyr’s mission is to transform addiction treatment in America. Changing language is a necessary step in that process.

Here’s is Alltyr’s guide to addiction language for the 21^st Century.

Instead of saying:	Say:
alcoholic	person with an alcohol use disorder (AUD)
addict	person with a substance use disorder (SUD)
alcohol /drug abuse	risky use, heavy drinking, risky drinking
sober	abstaining, in remission
betrayer, liar, cheat, thief, selfish	addicted person, sick, ill
enabler	loved one
enabling	unhelpful or unskillful behavior
tough love	self-care, setting reasonable limits and expectations
unmotivated, denial	ambivalent about change, non-adherent, not yet able to overcome barriers to change, demoralized
dry drunk	irritable, moody, troubled, erratic, struggling
slip, lapse, relapse	use episode, recurrence, set-back
recovery (abstinence + spiritual growth)	remission (absence of illness once present)
relapse	recurrence, set-back
relapse prevention	recovery skills training
treatment program	rehab
Treatment (meaning rehab)	treatment (includes all levels of care)
MAT (medication assisted treatment)	treatment, pharmacotherapy, anti-relapse meds
compliance	adherence
non-compliant	non-adherent
harm reduction	treatment, chronic care management, partial response

Want to learn more about The Alltyr Model of Care™? Visit our website: www.alltyr.com 

Substance Matters Blog is Back!

Hi Everyone,

The blog is back! In 2014, I stopped blogging because I was too busy to keep it interesting. With growth and other recent changes, we'll be starting to post again. A link to the blog is always available on www.Alltyr.com, so you don't have to worry about bookmarking this URL.

A lot has changed since 2014. Alltyr Clinic has grown, and development of the Alltyr Model of Care™ is complete. We are still located in downtown St. Paul, MN, but plan to expand into the west metro Twin Cities area. We are also looking at expansion in other states. The most likely new location is the Los Angeles area. Ian McLoone, who came aboard very early, helped me with the blog before, and will be posting as well.

I'm looking forward to continuing to do everything possible to disrupt the current corrupt and antiquated rehab system, and replace it with accessible, affordable, attractive and effective professional treatment.

Thanks for reading. Please comment on the posts.

And visit www.Alltyr.com to learn more about how far Alltyr Clinic has come!

The Myth of "Cross-Addiction" Debunked

For decades, the conventional wisdom and clinical lore in rehab facilities and recovery communities has warned against the risks of so-called "cross-addiction". "Be careful," they say, "you're at-risk of picking up a new addiction now that you've kicked one habit." Heroin addicts are warned against developing an addiction to alcohol, and cocaine addicts are warned against developing an addiction to opiates, Cross-addiction can even occur to things like exercise or sugar, according to pamphlets and even therapists who have worked in the field for years and years.

But is it even true? Is the notion of cross-addiction supported by empirical evidence - or does it fall on its face under scientific scrutiny?

According to a new report, published September 10 in JAMA Psychiatry, the answer is a resounding, "No."

The study, "Testing the Drug Substitution Switching-Addictions Hypothesis," analyzed data from the National Epidemiological Study on Alcohol and Related Conditions (NESARC) to investigate whether participants developed new-onset substance use disorders (SUD) after remission from a previous SUD. These data were then compared against people with a SUD who did not achieve remission but also developed a new-onset SUD.

The authors discovered that, "As compared with those who do not remit from an SUD, remitters have less than half the risk of developing a new SUD. Contrary to clinical lore, achieving remission does not typically lead to drug substitution but rather is associated with a lower risk of new SUD onsets."

This is probably the best evidence to-date that addresses the concept of cross-addiction. Will counselors and agencies begin to pull back from this concept - or will clients still be subjected to homework assignments and lectures warning against it?

Here's the abstract from JAMA Psychiatry (found here: http://archpsyc.jamanetwork.com/article.aspx?articleid=1901525):

Importance  Adults who remit from a substance use disorder (SUD) are often thought to be at increased risk for developing another SUD. A greater understanding of the prevalence and risk factors for drug substitution would inform clinical monitoring and management.

Objective  To determine whether remission from an SUD increases the risk of onset of a new SUD after a 3-year follow-up compared with lack of remission from an SUD and whether sociodemographic characteristics and psychiatric disorders, including personality disorders, independently predict a new-onset SUD.

Design, Setting, and Participants  A prospective cohort study where data were drawn from a nationally representative sample of 34 653 adults from the National Epidemiologic Survey on Alcohol and Related Conditions. Participants were interviewed twice, 3 years apart (wave 1, 2001–2002; wave 2, 2004–2005).

Main Outcomes and Measures  We compared new-onset SUDs among individuals with at least 1 current SUD at wave 1 who did not remit from any SUDs at wave 2 (n = 3275) and among individuals with at least 1 current SUD at wave 1 who remitted at wave 2 (n = 2741).

Results  Approximately one-fifth (n = 2741) of the total sample had developed a new-onset SUD at the wave 2 assessment. Individuals who remitted from 1 SUD during this period were significantly less likely than those who did not remit to develop a new SUD (13.1% vs 27.2%, P < .001). Results were robust to sample specification. An exception was that remission from a drug use disorder increased the odds of a new SUD (odds ratio [OR] = 1.46; 95% CI, 1.11-1.92). However, after adjusting for the number of SUDs at baseline, remission from drug use disorders decreased the odds of a new-onset SUD (OR = 0.66; 95% CI, 0.46-0.95) whereas the number of baseline SUDs increased those odds (OR=1.68; 95% CI, 1.43-1.98). Being male, younger in age, never married, having an earlier age at substance use onset, and psychiatric comorbidity significantly increased the odds of a new-onset SUD during the follow-up period.

Conclusions and Relevance  As compared with those who do not remit from an SUD, remitters have less than half the risk of developing a new SUD. Contrary to clinical lore, achieving remission does not typically lead to drug substitution but rather is associated with a lower risk of new SUD onsets.

Informed Consent in Addiction Treatment: An Ethical Obligation

Informed Consent in Opioid Addiction Treatment: An Ethical Obligation

This article was originally published in The Carlat Addiction Treatment Report, Volume 2, #3, May 2014

Source: 

 CATR, May 2014, Vol 2, Issue 3, Opioid Addiction

Mark Willenbring, MD

Founder and CEO, Alltyr Clinic, St. Paul, MN, Former Director, Division of Treatment and Recovery Research, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD

Dr. Willenbring has disclosed that he has no relevant financial or other interests in any commercial companies pertaining to this educational activity.

Informed consent—whether it be for psychotherapy, prescribing a medication, or performing a surgical procedure—is an ethical principle firmly established in law and medicine.

While there has been no formal research on this subject, my experience suggests that many addiction treatment programs fail to obtain valid informed consent. The starkest example occurs in the treatment of opioid addiction, where the practices and beliefs of clinicians often differ markedly from the evidence regarding effective treatments.

What is Informed Consent?

Informed consent refers to the collaborative process that a provider and patient go through to develop a treatment plan for the patient’s problems. This moral requirement is based on the principle of respecting a person’s autonomy, that is, their right “to hold views, to make choices, and to take actions based on their values and beliefs” (Beauchamp TL & Childress JF.Principles of Bio-medical Ethics, 7th ed. New York: Oxford University Press, 2013:122–123).

Valid consent fulfills three criteria (Grimm DA, N M Law Rev 2007;37(1):39–83). First, the patient needs to have decision-making capacity. Capacity, in a medical context, refers to patients’ ability to understand information, appreciate their situation, use reason to make a decision, and communicate their choices (Applebaum PS, N Engl J Med 2007;357(18):1834–1840). This is referred to as the “capacity” criterion.

Second, the provider needs to present the full range of available treatment options based on current scientific knowledge. During this discussion, he or she needs to outline the risks and benefits of these various options and what could be reasonably expected if the patient declines treatment altogether. This is called the “disclosure” criterion.

Finally, valid consent requires that patients are free from coercion—that is, they are in a position to voluntarily choose any treatment option that they feel is best for them. This is described as the “voluntariness” criterion.

A provider has failed to obtain valid informed consent if any of these elements are missing.

Legal Standards

Legal requirements for consent have evolved over centuries. Until relatively recently, courts used a physician-oriented point of view: the physician was required to provide information he or she felt was in the patient’s best interests. This resulted in practices such as informing a spouse, but not the patient, of a terminal disease. In other cases, providers deliberately omitted certain treatment options from their discussions with patients because of their personal beliefs or biases against them.

Through a series of court decisions, a new standard, the “reasonable person” or “prudent person” standard, emerged. Providers are now expected to present patients with information that a reasonable or prudent person would want to know in order to make healthcare decisions (Berg JW et al.Informed Consent: Legal Theory and Clinical Practice, 2d ed. New York: Oxford University Press, 2001:48).

In clinical practice, a provider is not allowed to withhold information from a patient based on his or her judgment that one treatment is better than another. The provider is thus required to present the scientific evidence supporting available treatment options, the expected outcomes of these various treatments, and the clinician’s recommendation for the patient and the rationale for it. This recommendation also needs to take into account any patient-specific features that factored into the provider’s decision-making.

This means that clinicians are legally obligated to provide information that they may prefer to withhold. The purpose of informed consent, however, is not to “conveniently promote a treatment plan; it requires informing patients with the recognition that they may disagree with a recommended treatment plan and retain the authority to do so” (Berg et al, op.cit).

There is also an important distinction between the actual process of obtaining autonomous authorization for a treatment or procedure and institutional requirements that patients sign informed consent documents. Patients frequently sign such documents in the absence of true informed consent (Beauchamp & Childress, op.cit).

Evidence-Based Treatment

Providers are obligated to summarize the scientific data concerning the effectiveness of various treatment options. The only treatment with consistent, strong evidence of effectiveness for opioid addiction is indefinite opioid maintenance therapy with either buprenorphine or methadone (Mattick RP et al, Cochrane Database Syst Rev 2014;2:CD002207).

Currently, the World Health Organization, US Centers for Disease Control and Prevention, US Department of Health and Human Services, and many other agencies and organizations recommend methadone and buprenorphine maintenance as first-line treatments.

In contrast, there is no evidence commending drug-free (or so-called abstinence-based) treatments (Mayet S et al, Cochrane Database Syst Rev2005;1:CD004330). Moreover, there is good evidence that psychosocial or intensive behavioral approaches fail to improve outcomes compared to minimal drug counseling in patients receiving opioid maintenance therapy (Amato L et al, Cochrane Database Syst Rev 2011;10:CD004147; Fiellin DA et al, Am J Med 2013;126(1):74.e11–17).

Naltrexone is the only other medication that has been approved by the FDA for opioid addiction. Oral naltrexone (ReVia) is ineffective (Minozzi S et al,Cochrane Database Syst Rev 2011;4: CD001333) and the efficacy of extended-release, injectable naltrexone (Vivitrol) was established in just a single, industry-sponsored study conducted in Russia, where buprenorphine and methadone are not legally available (Krupitsky E et al, Lancet2011;377(9776):1506–1513).

Presently, evidence for Vivitrol’s effectiveness is limited and generalization of clinical trial data to other countries is questionable. (For more, see“Vivitrol: Another Option for Opioid Addiction?”)

Meeting the Capacity Criterion

In addiction treatment, patients who are experiencing severe withdrawal symptoms may not have capacity due to pain and emotional distress. Other confounders include co-occurring mental disorders and cognitive impairment associated with prescribed medications and substances of abuse. Although beyond the scope of this article, simple bedside instruments allow providers to evaluate and easily document a patient’s decision-making capacity (Tunzi M, Am Fam Physician 2001;64(2):299–306).

Meeting the Disclosure Criterion

Providers need to have a clear understanding of available treatment options and the scientific evidence supporting each one, so they can meet their obligation concerning disclosure.

This article’s brief summary may serve as a starting point. Standard textbooks are also a ready source of such information (eg, Strain EC & Stitzer ML eds. The Treatment of Opioid Dependence. Baltimore, MD: Johns Hopkins University Press, 2006). In addition, a number of plain language resources geared toward patients are available (eg,http://1.usa.gov/1ibCKou).

Providers need to present patients with more than their program’s philosophy or even the community standard of care. Remember, the standard for disclosure is what a reasonable or prudent patient would want to know, not a narrow presentation concerning usual care or the provider’s personal preferences. In the case of opioid addiction, this means summarizing the scientific data on the effectiveness of treatment options. This is a fiduciary duty that trumps the clinician’s personal preferences and their program’s philosophy of care.

Meeting the Voluntariness Criterion

Providers need to be very sensitive to overt, and more subtle covert, coercion when discussing treatment options with patients. Many people presenting for substance use treatment are subject to significant coercion from the legal system, employers, and families. Thus, we need to ensure that consent is truly voluntary and that we are not using coercion to impose our own views concerning treatment upon patients.

This ethical obligation may require advocating for a treatment option different than what a judge, probation officer, employer, or family prefers or recommends.

CATR’s Take: Addiction treatment has historically been very prescriptive and patients often had little choice about the care that they received. This article is a good reminder that providers have an affirmative duty to obtain informed consent and engage patients in shared decision-making.

Alltyr Clinic Featured on NPR's Weekend Edition!

Alltyr Clinic is featured on NPR's Weekend Edition Sunday today, June 8, 2014. We are positioned as an alternative to traditional rehab, in this case Hazelden. One of our patients, Shane Linehan, was brave enough to share his experience with both Hazelden (where he went first) and Alltyr Clinic (where he is being treated now.) I want to thank him and applaud his courage for speaking out. (For the record, Alltyr Clinic gave him no incentive; we simply offered the opportunity to many of our patients.) We are honored to be compared to arguably the best known traditional rehab in the country (if not the world.)

Unfortunately, in the summary on the program's landing page, our approach is described as being almost totally oriented around prescribing anti-relapse medications. Although we use every proven anti-relapse medication, we also use every evidence-based behavioral/psychosocial approach. This includes individual and group therapy using motivational, cognitive-behavioral, coping skills, 12-Step Facilitation, EMDR, CRAFT, DBT, psychodynamic, community reinforcement, couples and family approaches. Which we use depends on the needs of the patient. Our team includes addiction psychiatrists, addiction medicine specialists, psychologists, social workers, counselors and recovery coaches.

Furthermore, we fully integrate treatment for any co-existing mental health disorder, such as anxiety, depression, PTSD, personality disorders, bipolar disorder, cognitive disorders, as well as medical problems such as insomnia and chronic pain. We really aim to be a "one-stop shop." If sober housing is needed we work with community partners to help our patients secure it. 

The bottom line is this: coming to Alltyr Clinic is like coming to a mental health clinic or any other health care service using a multi-disciplinary approach. Each patient receives a comprehensive individual evaluation upon which the treatment recommendations are based. Selecting from a large menu of services, a truly individualized treatment plan is arrived at by the patient, the treatment team, and if appropriate, the family. After treatment is started, the plan is modified as needed. The length and intensity of treatment is also completely individual and flexible. We do whatever we can and we stay with you as long as it takes. We aren't a program, we're a clinic.

At Alltyr Clinic, "We Don't Just Call Addiction a Disease, We Treat It Like One."TM

A Sad State of Affairs: Psychostimulant Addiction Treatment Leaves Much to be Desired

The authors of a new paper, published ahead of a special issue of Neuropharmacology, give the reader a good look at the current state of psychostimulant substance use disorder treatment - and the results are disappointing. Starting with behavioral treatments and ending with a review of medications, the clear fact remains that there is no single treatment that outperforms most others.

Meta-analyses of behavioral interventions for the treatment of cocaine use disorder have shown modest benefits; while one review found, "there is currently no evidence for a differential treatment effect of any psychosocial treatment in the management of" cocaine or amphetamine use disorders. CBT and Contingency Management (CM) remain the mainstay of psychostimulant treatment, and the authors cite data suggesting a combination of CM plus Community Reinforcement Approach might produce the best outcomes.

In terms of pharmacological treatments, researched medications include antagonist therapy, agonist therapy, medications to treat withdrawal symptoms and medications to treat co-occurring psychiatric symptoms or disorders; and the authors of the present paper devote the bulk of their attention to weighing the evidence of such options.

Naltrexone, they note, has shown some promise in laboratory studies, as it has been shown to weaken amphetamine- and cocaine-related effects in some subjects in both human and animal trials. Because it also seems to weaken the subjective euphoric effects of methylphenidate (Ritalin), one area of promise could be in the combination of naltrexone and methylphenidate to limit the abuse potential of an agonist-like treatment.

Disulfiram (aka Antabuse) has also shown some promise in the lab, but mainly in the treatment of cocaine-use disorders. It was shown to increase the brain ratio of dopamine to norepinephrine and to prevent stress-induced cocaine reinstatement. In pilot studies, disulfiram was shown to be effective in reducing cocaine use in patients with cocaine use disorders (CUD), and among buprenorphine-maintained polydrug users. However, in a more recent study, disulfiram showed less promise reducing cocaine use among methadone-maintained patients. The authors of the review point to evidence that disulfiram may only be effective among CUD patients with specific genotypes - and may be more effective among men than women.

Agonist-like treatments are also reviewed by the authors, and appear to offer some of the more exciting, and possibly effective, interventions for psychostimulant addiction. D-amphetamine has been shown to improve treatment retention and reduce illicit cocaine use in early trials; while a later study showed a reduction in withdrawal and craving, but a failure to reduce methamphetamine use. Not mentioned in the review, but a small study we wrote about in 2012 appeared to show promising results in the combination of mixed amphetamine salts (Adderall) and topiramate (Topamax)

For its part, sustained-release methamphetamine has been tested as a maintenance agent for CUD, and appeared to significantly reduce cocaine-positive urine samples and cocaine craving. The familiar medication, methylphenidate, has been shown to be non-superior to placebo in some studies for meth/amphetamine use and cocaine use, but appears to warrant further research at improved dosages. The other agonist-like medication discussed, modafanil, seems to be an interesting candidate for maintenance treatment. Known to be a cognitive enhancer, modafanil may be useful in addressing the impairments in a range of cognitive functions that can result from psychostimulant addiction; but studies have thus far produced more "equivocal" results in most trials as treatments for cocaine or for methamphetamine - even when combined with D-amphetamine. Post-hoc analysis of the available data does, however, suggest efficacy in the less severe cases of addiction.

Additionally, researchers in Latin America have argued in favor oral coca for the treatment of cocaine use disorder. Their "Handbook on Oral Cocaine as Agonist Therapy for Cocaine Dependence" is an intriguing read, and the authors of the review posit that political, cultural and commercial barriers - not scientific ones - are likely to blame for the "lack of follow-up on this line of research".

A host of other medications have been tried and tested for psychostimulant use disorders, with little success. Vaccines, on the other hand, are now gaining momentum in the field and are being used in multiple studies at various phases. A vaccine that that produces antibodies to prevent cocaine from crossing the blood-brain barrier has performed well in Phase I and Phase II trials. A methamphetamine vaccine is still in preclinical development, but initial results have shown good levels of antibodies in animal models and a Phase I  trial is scheduled to begin in 2015.

Considering the vast global toll which is the result of psychostimulant addiction, treatment for these disorders is as desperately needed as ever. If there is one thing that this review makes clear, it's the fact that we still have a long way to go before we can say that we have effective treatment options for the consumer. A question for readers of this blog: what are the techniques and interventions that you have found to be helpful stimulant use disorders? Is there a particular line of research that you feel would be important to investigate further? Do you see the utility of agonist-like medications? Your thoughts are always appreciated.

Many Patients with Alcohol Use Disorders Not Offered Medications

An exhaustive and brand new meta-analysis and systematic review, published today in the Journal of the American Medical Association, paints a disappointing picture of medication access for those with alcohol use disorders (AUD) in the US. The authors included 123 studies, involving nearly 23,000 participants, and determined that while acamprosate and naltrexone have been shown to be effective treatments, fewer than 10% of those who might benefit are ever prescribed an AUD medication.

Here's the Abstract, via JAMA:

IMPORTANCE Alcohol use disorders cause substantial morbidity and early mortality yet

remain greatly undertreated. Medications are considerably underused.

OBJECTIVE To conduct a systematic review and meta-analysis of the benefits and harms of

medications (US FDA-approved and others) for adults with alcohol use disorders.

DATA SOURCES PubMed, Cochrane Library, PsycINFO, CINAHL, EMBASE, FDA website, and

clinical trials registries (January 1, 1970, to March 1, 2014).

STUDY SELECTION Two reviewers selected randomized clinical trials (RCTs) with at least 12

weeks’ duration that reported eligible outcomes and head-to-head prospective cohort

studies reporting health outcomes or harms.

DATA EXTRACTION AND SYNTHESIS We conducted meta-analyses using random-effects

models and calculated numbers needed to treat for benefit (NNTs) or harm (NNHs).

MAIN OUTCOMES AND MEASURES Alcohol consumption, motor vehicle crashes, injuries,

quality of life, function, mortality, and harms.

RESULTS We included 122 RCTs and 1 cohort study (total 22 803 participants). Most assessed

acamprosate (27 studies, n = 7519), naltrexone (53 studies, n = 9140), or both. The NNT to

prevent return to any drinking for acamprosate was 12 (95% CI, 8 to 26; risk difference [RD],

−0.09; 95% CI, −0.14 to −0.04) and was 20 (95% CI, 11 to 500; RD, −0.05; 95% CI, −0.10 to

−0.002) for oral naltrexone (50 mg/d). The NNT to prevent return to heavy drinking was 12

(95% CI, 8 to 26; RD −0.09; 95% CI, −0.13 to −0.04) for oral naltrexone (50 mg/d).

Meta-analyses of trials comparing acamprosate to naltrexone found no statistically significant

difference between them for return to any drinking (RD, 0.02; 95% CI, −0.03 to 0.08) or

heavy drinking (RD, 0.01; 95% CI, −0.05 to 0.06). For injectable naltrexone, meta-analyses

found no association with return to any drinking (RD, −0.04; 95% CI, −0.10 to 0.03) or heavy

drinking (RD, −0.01; 95% CI, −0.14 to 0.13) but found an association with reduction in heavy

drinking days (weighted mean difference [WMD], −4.6%; 95% CI, −8.5% to −0.56%). Among

medications used off-label, moderate evidence supports an association with improvement in

some consumption outcomes for nalmefene (heavy drinking days per month: WMD, −2.0;

95% CI, −3.0 to −1.0; drinks per drinking day: WMD, −1.02; 95% CI, −1.77 to −0.28) and

topiramate (% heavy drinking days: WMD, −9.0%; 95% CI, −15.3% to −2.7%; drinks per

drinking day: WMD, −1.0; 95% CI, −1.6 to −0.48). For naltrexone and nalmefene, NNHs for

withdrawal from trials due to adverse events were 48 (95% CI, 30 to 112) and 12 (95% CI, 7 to

50), respectively; risk was not significantly increased for acamprosate or topiramate.

CONCLUSIONS AND RELEVANCE Both acamprosate and oral naltrexone were associated with

reduction in return to drinking. When directly compared with one another, no significant

differences were found between acamprosate and naltrexone for controlling alcohol

consumption. Factors such as dosing frequency, potential adverse events, and availability of

treatments may guide medication choice.

Would love to know what readers think about the results of this large study. What are the main drivers of this gap, and why aren't more patients requesting these medications? What needs to be done to improve access?

Who Benefits from Additional Drug Counseling among Prescription Opioid Dependent Patients on Suboxone?

In a secondary analysis of the Prescription Opioid Addiction Treatment Study (POATS), the original study's author, Roger Weiss, and colleagues parse the data to determine if there are common characteristics among those who benefited from additional opioid dependence counseling (ODC) - above and beyond the standard medical management (SMM) and buprenorphine-naloxone medication. It is a very good question, considering the host of recent studies which found no additional benefit to counseling in terms of measured outcomes, including the large and highly-regarded POATS.

In searching for an answer, the authors looked at two sources of variability - patient characteristics, and adherence to treatment. Specifically, the authors sought to answer three questions: 1) Did participants with more severe problems have better outcomes with SMM + ODC than with SMM alone (N=360)? 2) Among participants with adequate adherence to treatment, were those assigned to SMM + ODC more likely to have successful outcomes than those receiving SMM alone, regardless of severity (n = 266)? And 3), among participants with adequate adherence to treatment, were those with more severe problems more likely to succeed with additional counseling than with standard medical management only (n = 266)?

In response to question 1, the analysis found that "the association between severity and outcome did not vary by treatment condition for any of the three severity measures." Those without past use of heroin had more favorable outcomes across the entire study. Regarding question 2, "adequate adherence" was defined as attending at least 60% of scheduled scheduled sessions in both treatment conditions, and most participants (73.9%) attended at least 60% of sessions. Subjects in the SMM-only condition were more likely meet this criterion but, once again, outcomes did not differ by treatment condition. Finally, in answering question 3, the authors found that, "Among participants who had ever used heroin, those assigned to SMM + ODC were more likely to succeed than those in SMM only (66.7% vs. 35.0%, n = 70, χ2(1) = 6.88, p=.016)."

 Table 1

Likelihood of successful opioid use outcomes at Phase 2, weeks 9–12. ^a

	OR	95% CI      p Value
(a) All participants ( n= 360)
Main effects
Heroin	2.0	1.3–3.3      .004
Chronic pain	1.3	0.8–2.0      .240
Drug severity	2.9	0.2–58.2    .484
Interaction with Phase 2 treatment
Heroin	1.6	0.6–4.2      .342
Chronic pain	0.6	0.2–1.4      .218
Drug severity	0.2	0.0–76.8    .585	.
(b) Participants with adequate adherence to treatment ( n= 266)
Main effect of Phase 2 treatment	0.7	0.4–1.1     .107
Interaction with Phase 2 treatment
Heroin	3.7	1.1–11.8     .03
Chronic pain	0.5	0.2–1.5      .213
Drug severity	1.5	0.001–4023.5   .915

^a All models were adjusted for Phase 1 treatment condition.

Treatment outcomes did not appear to differ among those who had never used heroin, suggesting that prescription opioid-addicted patients with a history of heroin use may be the participants who are most likely to benefit from additional counseling in suboxone treatment. Importantly, those patients had to also attend enough sessions (and receive an adequate "dose" of counseling) in order to see their outcomes improve to rates similar to those without a history of heroin use.

So, do these results line up with the experience of the readers of this blog? Are there populations with whom you believe counseling is especially important? Or, do the results simply reinforce the lessons of past studies? Let us know