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 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.

Baclofen Shows Promise for Treating Relapse in Cocaine Use Disorders

Via ScienceDaily:

Relapse is the most painful and expensive feature of drug addiction -- even after addicted individuals have been drug-free for months or years, the likelihood of sliding back into the habit remains high. The National Institute on Drug Abuse estimates that 40 to 60 percent of addicted individuals will relapse, and in some studies the rates are as high as 80 percent at six months after treatment. Though some relapse triggers can be consciously avoided, such as people, places and things related to drug use, other subconscious triggers related to the brain's reward system may be impossible to avoid -- they can gain entry to the unconscious brain, setting the stage for relapse.

Researchers at Penn Medicine's Center for Studies of Addiction have now found that the drug baclofen, commonly used to prevent spasms in patients with spinal cord injuries and neurological disorders, can help block the impact of the brain's response to "unconscious" drug triggers well before conscious craving occurs. They suggest that this mechanism has the potential to prevent cocaine relapse. The new findings are reported in the Journal of Neuroscience.

"The study was inspired by patients who had experienced moments of 'volcanic craving', being suddenly overcome by the extreme desire for cocaine, but without a trigger that they could put their finger on," says senior author Anna Rose Childress, PhD,research professor of Psychiatry, director of the Brain-Behavioral Vulnerabilities Division in the Perelman School of Medicine at the University of Pennsylvania. Dr. Childress and colleagues previously found that subliminal drug "reminder cues" (the sights, sounds, smells, and memories of the drug) could activate the brain's reward circuit. "Now, we wanted to understand whether a medication could inhibit these early brain responses," said Childress.

Kimberly Young, PhD, an NIH/NIDA Post-doctoral Fellow at Penn, and first author of the study explained that, "Drug reward and motivation is largely mediated by dopamine transmission in the brain's reward circuit -- even drug "reminder cues" can cause dopamine release. Since baclofen and similar medications reduce these effects in laboratory animals, we wanted to examine whether it could prevent drug-cue induced activation in the human brain."

The study tested baclofen, which was approved by the U.S. Food and Drug Administration in 1977 for spasm, on 23 cocaine-dependent men, ages 18 to 55. Each reported using cocaine on at least eight of 30 days before screening. Inclusion in the study required that they stay for up to 10 days in a supervised inpatient drug treatment facility, be drug-free for the duration, not be on any medication affecting dopamine or neurotransmitter response, and have no history of psychosis, seizures, or brain syndromes unrelated to cocaine use.

Upon admission, patients were randomized to receive baclofen or placebo. Over the first six days, patients in the baclofen group received the medication in increasing dosage to 60 mg. While on the full 60 mg dose of baclofen, patients were placed in an fMRI and shown a series of images, to measure their neural responses to "ultra-brief" pictures of cocaine or other comparison pictures. Each of the ultra-brief 33 msec "target" pictures was immediately followed by longer picture of non-drug objects or scenes. Under these conditions, the participants are aware of the longer pictures, but the ultra-brief target pictures remain completely outside conscious awareness -- they are "backward-masked."

"We wanted to present the key stimulus: images of drug use and preparation, sexual images, and other aversive images in a way such that the brain could not consciously process them, but so that we could measure their earliest, subconscious effect on the brain," said Childress.

What the team found was that the patients who were treated with baclofen showed a significantly lower response in the reward and motivational circuits to subliminal cocaine cues versus neutral cues, as compared to the placebo-treated control group. In addition, no difference was seen in the active versus the control group in their response to sexual and aversive cues, indicating that the effects of baclofen on cue-induced brain activation were specific to drug cues.

"These findings suggest that the brain response to drug cues presented outside of awareness can be pharmacologically inhibited, providing a mechanism for baclofen's potential therapeutic benefit in addiction," says Young. "Further studies will show whether the prevention of these early brain responses is associated with reduced rates of craving and relapse in cocaine-dependent patients," added Childress. 

Source: http://www.sciencedaily.com/releases/2014/04/140401172914.htm

This could be exciting news for one of the most difficult substance use disorders to treat. Does anyone have experience using baclofen with patients with cocaine use disorders?

Study: Are Drug Screens Sufficient for Adolescent Treatment?

Could it be that we are missing something when it comes to treating adolescents with a substance use disorder? According to a study in the most recent edition of the Journal of Studies on Alcohol Drugs, if you aren't using drug screens when treating this population, the answer is likely "Yes".
In the article, Schuler, et al. looked at data from SAMHSA's CSAT 2007 adolescent treatment database, which tracks outcomes for CSAT-sponsored providers. The total sample consisted of 5,186 adolescents who received either Motivational Enhancement Therapy/Cognitive Behavioral Therapy5 (MET/CBT5) - with or without biological drug screen (BDS) - or were part of the BDS-only or No-Treatment groups within another study. Below is a breakdown of the subjects:

All participants responded to the GAIN structured clinical interview, so scores on the Substance Use Frequency Scale and Substance Problem Scale were the primary outcomes measured. Propensity score methods were used to adjust for baseline differences among youth in the four groups, given the non-randomized nature of the data. The results are striking:

The BDS-only condition seemed to outperform all groups at baseline, 3-, 6- and 12-months on Substance Problem Scale scores and at 6- and 12-months on Substance Frequency Scale scores.
What could account for the significant differences? The authors point out that many adolescents who are involved in treatment and/or the criminal justice system may earn rewards for negative drug screens - or face significant consequences for positive screens. Therefore, the self-report nature of the data could skew the results. That would not necessarily explain the consistent differences across groups, however.

What do you think about these results? If you work with adolescents, does this surprise you? Could evidence like this impact the interventions you use?

Americans Spending $100 Billion on Illegal Drugs Annually

The U.S. White House Office of National Drug Control Policy (ONDCP) commissioned the RAND Corporation to investigate how much Americans were spending on the four most common illegal drugs from 2000-2010. The study, published recently on the whitehouse.gov website, uses a variety of sources to develop an estimate in yearly spending by consumers of cannabis, heroin, cocaine (including crack), and methamphetamine. Their conclusion: over $100 billion is spent on just these four drugs, every year. Interestingly, this number has stayed relatively constant throughout the past decade, despite the $25.2 billion that was spent "to reduce drug use and its consequences" in the US in fiscal year 2014 alone (!).

Since 2002, spending on cocaine and marijuana has flipped. Researchers note that cocaine consumption has dropped by about half, while marijuana consumption has increased by around 40%. Heroin consumption has remained stable throughout the decade, with a small increase detected in the later years. Methamphetamine consumption, the authors note, has been harder to track, as "national datasets do not do a good job of capturing its use." Across the board, heavy users are the main drivers of spending and consumption, and are defined as folks who use at least 21 days/month.

The authors culled data from a variety of sources, including the National Survey on Drug Use and Health, the Arrestee Drug Abuse Monitoring Program, various law enforcement and seizure databases, and more. Despite the apparent rigor involved in the creation of these estimates, the authors caution about the inherent uncertainty in this type of data analysis - especially considering that the bulk of the data came from self-report surveys.

Nevertheless, the fact remains that despite the increasing public investments in the so-called War on Drugs, demand-side consumption and expenditures are constant or rising throughout the country. Could this be one reason the Attorney General has agreed to endorse changes to Federal drug sentencing? What do readers think about the current state of availability and expense?

You can read the full report here:

http://www.whitehouse.gov/ondcp/research-and-data/estimation-drug-expenditures-consumption-supply

Study: Healthcare Utilization Rates After Treatment Are Equivalent Among Abstinent and Low-Risk Drinkers

A fascinating new study will add to the small, but growing, treatment literature suggesting that low-risk drinking is a viable option for people receiving treatment for alcohol-use disorders. The paper, published this month in Alcoholism: Clinical and Experimental Research, measured healthcare utilization rates and associated costs over a 5-year period among clients receiving treatment in a large Northern California healthcare system. The results show that outcomes for abstainers and lower-risk drinkers were equivalent (and far better than the high-risk drinkers), despite the fact that the abstinence-based treatment received by all groups was the same.

According to the authors, "The finding that lower-risk drinkers did not differ from those of abstinent individuals, in inpatient use in particular, even when controlling for patient characteristics, suggests that a health policy perspective may consider benefits of lower-risk drinking."

Here's the abstract via Wiley:

Background

Lower-risk drinking is increasingly being examined as a treatment outcome for some patients following addiction treatment. However, few studies have examined the relationship between drinking status (lower-risk drinking in particular) and healthcare utilization and cost, which has important policy implications.

Methods

Participants were adults with alcohol dependence and/or abuse diagnoses who received outpatient alcohol and other drug treatment in a private, nonprofit integrated healthcare delivery system and had a follow-up interview 6 months after treatment entry (N = 995). Associations between past 30-day drinking status at 6 months (abstinence, lower-risk drinking defined as nonabstinence and no days of 5+ drinking, and heavy drinking defined as 1 or more days of 5+ drinking) and repeated measures of at least 1 emergency department (ED), inpatient or primary care visit, and their costs over 5 years were examined using mixed-effects models. We modeled an interaction between time and drinking status to examine trends in utilization and costs over time by drinking group.

Results

Heavy drinkers and lower-risk drinkers were not significantly different from the abstainers in their cost or utilization at time 0 (i.e., 6 months postintake). Heavy drinkers had increasing odds of inpatient (p < 0.01) and ED (p < 0.05) utilization over 5 years compared with abstainers. Lower-risk drinkers and abstainers did not significantly differ in their service use in any category over time. No differences were found in changes in primary care use among the 3 groups over time. The cost analyses paralleled the utilization results. Heavy drinkers had increasing ED (p < 0.05) and inpatient (p < 0.001) costs compared with the abstainers; primary care costs did not significantly differ. Lower-risk drinkers did not have significantly different medical costs compared with those who were abstinent over 5 years. However, post hoc analyses found lower-risk drinkers and heavy drinkers to not significantly differ in their ED use or costs over time.

Conclusions

Performance measures for treatment settings that consider treatment outcomes may need to take into account both abstinence and reduction to nonheavy drinking. Future research should examine whether results are replicated in harm reduction treatment, or whether such outcomes are found only in abstinence-based treatment.

Figure 1 shows Adjusted odds ratios of utilization by 6-month drinking group over time:

Figure 2 shows Adjusted average costs per member month by 6-month drinking group over time:

                                               






As mentioned above, these are the results from patients who attended abstinence-based treatment. It will be
interesting to see if these results are replicated among patients who are instructed on low-risk drinking. What experience do readers have with this issue? Do results like these make those directing abstinence-based programs think twice about the policy? It would be great to hear from you.

Hat tip: Thanks, Dr Reid Hester, for bringing this study to our attention.

Source: Kline‐Simon, A. H., Weisner, C. M., Parthasarathy, S., Falk, D. E., Litten, R. Z., & Mertens, J. R. (2013). Five‐Year Healthcare Utilization and Costs Among Lower‐Risk Drinkers Following Alcohol Treatment. Alcoholism: Clinical and Experimental Research.
http://onlinelibrary.wiley.com/doi/10.1111/acer.12273/abstract

Vermont Governor Devotes Entire State of the State Address to Drug Addiction

From yesterday's NY Times:

In Annual Speech, Vermont Governor Shifts Focus to Drug Abuse

In a sign of how drastic the epidemic of drug addiction here has become, Gov. Peter Shumlin on Wednesday devoted his entire State of the State Message to what he said was “a full-blown heroin crisis” gripping Vermont.

“In every corner of our state, heroin and opiate drug addiction threatens us,” he said. He said he wanted to reframe the public debate to encourage officials to respond to addiction as a chronic disease, with treatment and support, rather than with only punishment and incarceration.

“The time has come for us to stop quietly averting our eyes from the growing heroin addiction in our front yards,” Governor Shumlin said, “while we fear and fight treatment facilities in our backyards.”

...

Read the rest of the story here: 

http://www.nytimes.com/2014/01/09/us/in-annual-speech-vermont-governor-shifts-focus-to-drug-abuse.html

Cochrane Releases New Reviews on MAT

The highly-respected Cochrane Library, known for its meticulous reviews of the current state of medical knowledge, has updated and released two reviews on medication-assisted treatment recently. The first, "Maintenance agonist treatments for opiate-dependent women", aims to " assess the effectiveness of any maintenance treatment alone or in combination with psychosocial intervention compared to no intervention, other pharmacological intervention or psychosocial interventions for child health status, neonatal mortality, retaining pregnant women in treatment and reducing the use of substances." The second, "Pharmacological interventions for drug-using offenders" aims to " assess the effectiveness of pharmacological interventions for drug-using offenders in reducing criminal activity and/or drug use." In both cases, the authors note the effectiveness of opioid medications in assisting patients to achieve desired outcomes (although the effect on criminal activity in the second study was significant, but less pronounced). However, they cautioned against generalizing the findings as the body of evidence of both topics is still too small.

Here are the abstracts, via Wiley:

Maintenance agonist treatments for opiate-dependent pregnant women

Abstract

Background

The prevalence of opiate use among pregnant women can range from 1% to 2% to as high as 21%. Heroin crosses the placenta and pregnant, opiate-dependent women experience a six-fold increase in maternal obstetric complications such as low birth weight, toxaemia, third trimester bleeding, malpresentation, puerperal morbidity, fetal distress and meconium aspiration. Neonatal complications include narcotic withdrawal, postnatal growth deficiency, microcephaly, neuro-behavioural problems, increased neonatal mortality and a 74-fold increase in sudden infant death syndrome.

Objectives

To assess the effectiveness of any maintenance treatment alone or in combination with psychosocial intervention compared to no intervention, other pharmacological intervention or psychosocial interventions for child health status, neonatal mortality, retaining pregnant women in treatment and reducing the use of substances.

Search methods

We searched the Cochrane Drugs and Alcohol Group Trials Register (September 2013), PubMed (1966 to September 2013), CINAHL (1982 to September 2013), reference lists of relevant papers, sources of ongoing trials, conference proceedings and national focal points for drug research. We contacted authors of included studies and experts in the field.

Selection criteria

Randomised controlled trials assessing the efficacy of any maintenance pharmacological treatment for opiate-dependent pregnant women.

Data collection and analysis

We used the standard methodological procedures expected by The Cochrane Collaboration.

Main results

We found four trials with 271 pregnant women. Three compared methadone with buprenorphine and one methadone with oral slow-release morphine. Three out of four studies had adequate allocation concealment and were double-blind. The major flaw in the included studies was attrition bias: three out of four had a high drop-out rate (30% to 40%) and this was unbalanced between groups.

Methadone versus buprenorphine: the drop-out rate from treatment was lower in the methadone group (risk ratio (RR) 0.64, 95% confidence interval (CI) 0.41 to 1.01, three studies, 223 participants). There was no statistically significant difference in the use of primary substance between methadone and buprenorphine (RR 1.81, 95% CI 0.70 to 4.69, two studies, 151 participants). For both, we judged the quality of evidence as low. Birth weight was higher in the buprenorphine group in the two trials that could be pooled (mean difference (MD) -365.45 g (95% CI -673.84 to -57.07), two studies, 150 participants). The third study reported that there was no statistically significant difference. For APGAR score neither of the studies which compared methadone with buprenorphine found a significant difference. For both, we judged the quality of evidence as low. Many measures were used in the studies to assess neonatal abstinence syndrome. The number of newborns treated for neonatal abstinence syndrome, which is the most critical outcome, did not differ significantly between groups. We judged the quality of evidence as very low.

Methadone versus slow-release morphine: there was no drop-out in either treatment group. Oral slow-release morphine seemed superior to methadone for abstinence from heroin use during pregnancy (RR 2.40, 95% CI 1.00 to 5.77, one study, 48 participants). We judged the quality of evidence as moderate.

Only one study which compared methadone with buprenorphine reported side effects. For the mother there was no statistically significant difference; for the newborns in the buprenorphine group there were significantly fewer serious side effects.

In the comparison between methadone and slow-release morphine no side effects were reported for the mother, whereas one child in the methadone group had central apnoea and one child in the morphine group had obstructive apnoea.

Authors' conclusions

We did not find sufficient significant differences between methadone and buprenorphine or slow-release morphine to allow us to conclude that one treatment is superior to another for all relevant outcomes. While methadone seems superior in terms of retaining patients in treatment, buprenorphine seems to lead to less severe neonatal abstinence syndrome. Additionally, even though a multi-centre, international trial with 175 pregnant women has recently been completed and its results published and included in this review, the body of evidence is still too small to draw firm conclusions about the equivalence of the treatments compared. There is still a need for randomised controlled trials of adequate sample size comparing different maintenance treatments.

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006318.pub3/abstract

 

Pharmacological interventions for drug-using offenders

Abstract

Background

The review represents one in a family of four reviews focusing on a range of different interventions for drug-using offenders. This specific review considers pharmacological interventions aimed at reducing drug use and/or criminal activity for illicit drug-using offenders.

Objectives

To assess the effectiveness of pharmacological interventions for drug-using offenders in reducing criminal activity and/or drug use.

Search methods

Fourteen electronic bibliographic databases (searched between 2004 and 21 March 2013) and five additional Web resources (searched between 2004 and 11 November 2011) were searched. Experts in the field were contacted for further information.

Selection criteria

Randomised controlled trials assessing the efficacy of any pharmacological interventions for reducing, eliminating or preventing relapse in drug-using offenders were included. Data on the cost and cost-effectiveness of interventions were reported.

Data collection and analysis

We used standard methodological procedures as expected by The Cochrane Collaboration.

Main results

A total of 76 trials across the four reviews were identified. After a process of prescreening had been completed, 17 trials were judged to meet the inclusion criteria for this specific review (six of the 17 trials are awaiting classification for the review). The remaining 11 trials contained a total of 2,678 participants. Nine of the eleven studies used samples with a majority of men. The interventions (buprenorphine, methadone and naltrexone) were compared to non pharmacological treatments (e.g., counselling) and other pharmacological drugs. The methodological trial quality was poorly described, and most studies were rated as 'unclear' by the reviewers. The biggest threats to risk of bias were generated through blinding (performance and detection bias) and incomplete outcome data (attrition bias). When combined, the results suggest that pharmacological interventions do significantly reduce subsequent drug use using biological measures, (three studies, 300 participants, RR 0.71 (95% CI 0.52 to 0.97)), self report dichotomous data (three studies, 317 participants, RR 0.42, (95% CI 0.22 to 0.81)) and continuous measures (one study, MD -59.66 (95% CI -120.60 to 1.28)) . In the subgroups analysis for community setting, (two studies, 99 participants: RR 0.62 (95% CI 0.35 to 1.09)) and for secure establishment setting, (one study, 201 participants: RR 0.76 (95% CI 0.52 to 1.10)), the results are no longer statistically significant. Criminal activity was significantly reduced favouring the dichotomous measures of re arrest, (one study, 62 participants, RR 0.60 (95% CI 0.32 to 1.14)), re-incarceration, (three studies, 142 participants, RR 0.33 (95% CI 0.19 to 0.56)) and continuous measures (one study, 51 participants, MD -74.21 (95% CI -133.53 to -14.89)). Findings on the effects of individual pharmacological interventions on drug use and criminal activity show mixed results. Buprenorphine in comparison to a non pharmacological treatment seemed to favour buprenorphine but not significantly with self report drug use, (one study, 36 participants, RR 0.58 (95% CI 0.25 to 1.35)). Methadone and cognitive behavioural skills in comparison to standard psychiatric services, did show a significant reduction for self report dichotomous drug use (one study, 253 participants, RR 0.43 (95% CI 0.33 to 0.56)) but not for self report continuous data (one study 51 participants) MD -0.52 (95% CI -1.09 to 0.05)), or re incarceration RR 1.23 (95% CI 0.53 to 2.87)). Naltrexone was favoured significantly over routine parole and probation for re incarceration (two studies 114 participants, RR 0.36 (95% CI 0.19 to 0.69)) but no data was available on drug use. Finally, we compared each pharmacological treatment to another. In each case we compared methadone to: buprenorphine, diamorphine and naltrexone. No significant differences were displayed for either treatment for self report dichotomous drug use (one study, 193 participants RR 1.23 (95% CI 0.86 to 1.76)), continuous measures of drug use MD 0.70 (95% CI -5.33 to 6.73) or criminal activity RR 1.25 (95% CI 0.83 to 1.88)) between methadone and buprenorphine. Similiar results were found for comparisons with Diamorphine with no significant differences between the drugs for self report dichotomous drug use for arrest (one study, 825 participants RR 1.25 (95% CI 1.03-1.51)) or Naltrexone for dichotomous measures of re incarceration (one study, 44 participants, RR 1.10 (95% CI 0.37 to 3.26)), and continuous outcome measure of crime MD -0.50 (95% CI -8.04 to 7.04)) or self report drug use MD 4.60 (95% CI -3.54 to 12.74)).

Authors' conclusions

Pharmacological interventions for drug-using offenders do appear to reduce overall subsequent drug use and criminal activity (but to a lesser extent). No statistically significant differences were displayed by treatment setting. Individual differences are displayed between the three pharmacological interventions (buprenorphine, methadone and naltrexone) when compared to a non pharmacological intervention, but not when compared to each other. Caution should be taken when interpreting these findings, as the conclusions are based on a small number of trials, and generalisation of these study findings should be limited mainly to male adult offenders. Additionally, many studies were rated at high risk of bias because trial information was inadequately described.

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD010862/abstract

If You Build It, They Will Drink

If there were lingering doubts about the effect of alcohol availability on alcohol consumption, a host of new studies seem to lead the reader to the same conclusion: that increases in availability are correlated to increases in consumption. In other words: if you build it (bar, liquor store, etc), we will drink. What's more, in many cases, it's not just drinking that will happen. So-called alcohol outlet density has been linked to interpersonal and intimate partner violence, adolescent consumption and beliefs about alcohol, and even alcohol-attributable deaths. On the other hand, raising the minimum prices or implementing taxes on alcohol sales seems to go a long way in reducing these potential harms.

The journal, Addiction, has published several of these studies online in the past few weeks. Gruenewald and colleagues analyzed survey data from 50 California cities with populations between 50,000 - 500,000. They found "greater on-premise outlet densities were related to greater drinking frequencies and volumes, and use of on-premise drinking places" (like bars and restaurants).  The researchers concluded that, in addition to characteristics of the individual drinkers (e.g. "impulsivity, risky driving), alcohol availability is correlated with consumption and related problems.

Also in-press at Addiction, Paschall and colleagues analyzed the same sample, but instead focused on adolescent drinking. Some 1478 California youths, aged 13-17, responded to survey questions about past-year alcohol consumption, perceived availability, and questions related to underage enforcement and parental views toward drinking. The answers to these questions were then compared against alcohol outlet (bar) density, public policy, law enforcement activity and city demographics. The authors found that adolescent behaviors and attitudes were significantly affected by their environments. For example, past-year alcohol use was positively correlated to bar density and inversely correlated to "the comprehensiveness and stringency of local alcohol policies". In addition, higher rates of adult drinking were associated with greater increases of past-year adolescent drinking over the three-year study period.

Over in Alcohol and Alcoholism, Grubesic and colleagues studied the association between outlet density in Philadelphia and violent crime. Once again, the researchers found consistent association between the two. Here is a pair of maps, the first showing assault density, the second showing outlet density:

Contrary to the popular belief, no association was found between assault density and "transportation nodes and risky retailers". However, alcohol expenditures and general commercial activity were "positively and significantly" associated with assault density. 

The connection between intimate partner violence (IPV) and alcohol outlet density seems to be well established. In 2012, Conradi and colleagues reported that the density of bars in California was positively associated with IPV-related emergency department visits between 2005-2008. Then, earlier this year, Waller and colleagues found alcohol outlet density to be positively correlated to male-to-female physical - but not sexual - IPV among a national sample. Finally, in March, Zhao and colleagues showed that alcohol outlet density was associated with an increase in alcohol-attributable deaths in British Columbia between 2002-2009. In fact, they calculated that a 10% increase in private liquor stores was associated with a 2.45%, 2.36% and 1.99% increase in acute, chronic and total alcohol-associated (AA) mortality rates.

Interestingly, the single policy that seemed to have the biggest impact in turning these numbers around: raising the minimum price for alcohol. A 10% increase in the minimum price was associated with a 31.72% reduction in "wholly AA deaths". Pretty big numbers. As Dr W observed recently, "raising taxes on alcohol would do more for public health than all the treatment in the world." 

What do you think?

MMT and 12-Step Groups: Stigma Persists

In his latest contribution to the academic literature, William L. White and colleagues turn their focus on 12-Step participation among patients in methadone maintenance treatment (MMT). Rates of self-reported Narcotics Anonymous (NA) and Alcoholics Anonymous (AA) attendance were very high; however, participants frequently reported that their MMT status prevented them from taking part in many of the "key ingredients" of the groups that most members take for granted. When asked about the experience, nearly half of all respondents who had attended NA or AA reported that they had "received negative comments about methadone use" and nearly "a quarter (24.4%) reported having had a serious problem within NA or AA related to their status as a methadone patient."

The following table from the report details the "frequency with which respondents faced particular challenges":

Table 4: NA and AA Responses to MMT Patient Status                                NA            AA

Response to MM Patient Status:                                                                         (n=228)     (n=142)

Received negative comments about methadone use                                                43.0%     45.1%

Were pressured to reduce the dose of methadone                                                  21.9%     23.2%

Were pressured to stop taking methadone                                                             32.9%     34.5%

Were denied the right to speak at a meeting because of being
in methadone treatment                                                                                         14.5%      14.1%

Were denied the right to become a sponsor because of being                                  8.8%        9.9%
in methadone treatment


White and colleagues implemented this small study at not-for-profit opioid treatment program (OTP) in the Northeastern US. A total of 322 respondents answered a 53-question survey about their participation in recovery support groups. Of the 322, 259 (80.4%) reported a primary affiliation with a recovery support group. Of these, 88.8% reported it to be in some way a 12-Step group. Importantly, 66% of respondents reported past-year NA/AA participation, with 88-89% reporting the group was "helpful".

Despite these figures, the authors found MMT patients had low rates of participation in the "key ingredients" that seem to be critical influencers of long-term recovery outcomes: having a home group (50%), having a sponsor (26%), sponsoring others (13%), attending 12-Step social events (23%), and active step work (21%).

Anecdotally, we see a lot of patients at Alltyr who have a hard time finding a place in the local 12-Step scene. We even began compiling a list of medication-friendly meetings in the Twin Cities as we learned about them, but the stigma associated with maintenance is still prevalent. Could it be that we are on the verge of another breakthrough in medication acceptance? After all, there was a time when you weren't considered "sober" if you were on antidepressant or antipsychotic medications (but now, as Dr W likes to say, you're more likely to be referred to the psychiatrist by your sponsor than by anyone else). We would be interested to hear reader stories about this experience - or opinions on the topic. Are things changing - or not?

See the full paper by White, et al., here: http://www.williamwhitepapers.com/pr/2013%20Co-participation%20in%2012-Step%20Groups%20and%20Methadone%20Maintenance.pdf

Sunday Alcohol Blue Laws: Keeping consumption in-check?

In a brand new paper by SUNY economist Bans Yoruk, the author analyzes alcohol consumption rates in five states which recently repealed laws banning the sale of alcohol on Sundays. The findings, published online this month in the journal Addiction, show that in three of the five states, per capita alcohol consumption rose significantly in the years following the repeals. Beer seems to be the type of alcohol responsible for most of the increase across the states, with wine and spirits seeing small, if any, changes in demand.

The five states studied were Delaware, which repealed its law against Sunday alcohol sales in 2003, as did Massachusetts and Pennsylvania; Rhode Island, which repealed in 2004; and New Mexico, where the law was changed in 1995. The three states whose per capita consumption increased were Delaware (from 4% pre-repeal to 4.7% post-repeal), Pennsylvania (4% to 4.6%), and New Mexico (6.5% to 7.1%). The increase in Rhode Island was “small and statistically insignificant,” and there was no change in Massachusetts. (Interestingly, the demand for beer seemed to drive the up-tick in sales – all three states where the overall demand rose saw beer consumption increase by about a full percentage point.) The five states were then compared to control states, like our beautiful Minnesota, where alcohol Blue Laws remain in effect. 

Here's the graph from the paper:

Professor Yoruk's analysis falls on the heels of another study which tracked the effects of, among other variables, perceived alcohol availability and bar density on adolescent alcohol consumption. Paschall, et al. found such environmental factors contributed significantly to higher rates of past-year alcohol use. Could it be that an archaic and puritanical relic could actually be saving some lives? Will be interesting to see what readers think about the issue…

Sources:

        Paschall, M. J., Lipperman‐Kreda, S., & Grube, J. W. (2013). Effects of the Local Alcohol Environment on Adolescents’ Drinking Behaviors and Beliefs.Addiction.

        Yörük, B. K. (2013). Legalization of Sunday alcohol sales and alcohol consumption in the United States. Addiction.

Buprenorphine: 4 Counseling: 0

It hasn’t been a good couple years for counseling in the buprenorphine treatment literature. Yet another study, authored by a team led by the venerable Walter Ling, and currently available in Addiction Journal’s “early view” section online, has shown that counseling adds nothing to buprenorphine maintenance, in terms of measured outcomes. By our count, this makes four consecutive studies to show basically the same thing: counseling, while by no means harmful, has not been shown to add anything to buprenorphine maintenance in opioid-dependent patients without significant co-occurring psychiatric disorders.

Ling, et al.’s study is arguably the most convincing study yet. The team performed a randomized control trial in which patients were randomized to one of four behavioral treatment conditions, as adjuncts to buprenorphine maintenance: cognitive behavioral therapy (CBT), contingency management (CM), both CBT and CM, and no behavioral treatment. Counselors were master’s-level trained counselors who met with patients weekly for the initial phase of the study.

The results showed no differences in opioid use after the behavioral treatment phase, during the second (medication-only) phase, or at follow-ups at weeks 40 or 52. In addition, there were no statistically-significant differences in any of the secondary measures (retention, other drug use, withdrawal and craving, addiction severity index ratings, and adverse events).

Interestingly, there were differences in reported treatment satisfaction ratings. While the majority of participants reported being “very satisfied” with treatment, and 85% reported Suboxone was “very effective”, just 60% reported that their behavioral treatment was “very effective”. On the other hand, 21% of the no-treatment group reported that their behavioral treatment was “not effective”, compared to 3% of the CBT group and 0% of the CBT + CM group.

As a student of behavioral health counseling, this science is particularly hard to swallow. However, it does seem to affirm the fact that, for patients with opioid-use disorders, ensuring easy and affordable access to maintenance medications is currently our best and most important tool for their treatment.

What do you think?