Not available?

Another study finds no benefit from cognitive behavioral therapy and contingency management with opiate replacement treatment. [CORRECTED: See below]

Background and aims
The Controlled Substances Act requires physicians in the United States to provide or refer to behavioral treatment when treating opioid-dependent individuals with buprenorphine; however no research has examined the combination of buprenorphine with different types of behavioral treatments. This randomized controlled trial compared the effectiveness of 4 behavioral treatment conditions provided with buprenorphine and medical management (MM) for the treatment of opioid dependence.

Design
After a 2-week buprenorphine induction/stabilization phase, participants were randomized to 1 of 4 behavioral treatment conditions provided for 16 weeks: Cognitive Behavioral Therapy (CBT=53); Contingency Management (CM=49); both CBT and CM (CBT+CM=49); and no additional behavioral treatment (NT=51).

Setting
Study activities occurred at an outpatient clinical research center in Los Angeles, California, USA.

Participants
Included were 202 male and female opioid-dependent participants.

Measurements
Primary outcome was opioid use, measured as a proportion of opioid-negative urine results over the number of tests possible. Secondary outcomes include retention, withdrawal symptoms, craving, other drug use, and adverse events.

Findings
No group differences in opioid use were found for the behavioral treatment phase (Chi-square=1.25, p=0.75), for a second medication-only treatment phase, or at weeks 40 and 52 follow-ups. Analyses revealed no differences across groups for any secondary outcome.

Conclusion
There remains no clear evidence that cognitive behavioural therapy and contingency management reduce opiate use when added to buprenorphine and medical management in opiates users seeking treatment.

The question remains, why do patients on opiate replacement receive no benefit from these additional treatments? Particularly when they have been repeatedly shown to benefit addicts not on opiate replacement?

A recent post mentioned an expert’s observation that patients on opioids seem to “opt out of life.”

Are these patients less available to participate in other treatments? We asked this question in our position paper on buprenorphine maintenance.

[Correction: I appear to have had too many tabs open and made a stupid mistake. Thanks to Ian McLoone for pointing out the error. The prevous version erroneously said: “This time the drug is methadone. (It’s worth noting that the study received funding from the manufacturer of Suboxone. There have been similar findings about Suboxone and behavioral therapies. I guess they wanted to show that methadone is no better in this respect.)”]

12 Comments

Filed under Controversies, Policy, Research, Treatment

12 responses to “Not available?

  1. I am actually seeing that this drug is also Buprenorphine (Subutex), just as the previous study. Correct me if I am wrong…
    BTW – to me, these findings are consistent with the fact that the opioid-dependent brain has undergone structural changes that are permanent or very long-lasting. Thus, pharmacological interventions seem to be the only consistent way to “normalize” the brain function. The “opt-out of life” judgment is a harsh, moralistic one that is not doing anyone any favors, and in fact, could very easily be interpreted in a way that would prevent someone from seeking help – the very thing professionals would NOT want to happen.
    Ian

  2. You’re correct about the methadone/buprenorphine mistake. Thanks for pointing it out. I guess I was looking at too many tabs at once.

    Are opioid addicted doctors immune to behavioral treatments?

    The whole premise of this article was that there is evidence that behavioral treatments like CM and CBT are effective in treating opioid dependence, but the evidence is less clear when combined with buprenorphine.

    Here’s what the author’s said:

    Cognitive Behavioral Therapy (CBT) is associated with significant reductions in drug use (16-20), and in HIV-risk behaviors (21), and CBT benefits are sustained for significant durations after discontinuation of treatment (20,22). In a group or individual counseling session, CBT addresses intrapersonal and social/environmental influences that maintain substance use problems and provide coping skills training to prevent relapse. Sessions focus on behavior change principles including identifying relapse triggers, coping skills development, “breaking the cycle” of addictive behaviors, maintaining new lifestyle behaviors, and increasing self-efficacy.

    Contingency Management (CM) interventions view behavior as controlled or shaped by its consequences (23-24), and drug use is maintained by positive reinforcement (25). As such, providing appropriate non-drug reinforcers should decrease substance use (26-30). CM procedures are successful in initiating periods of abstinence compared to standard treatment regimens (31) and have produced relatively long periods of abstinence (32-34). A variation of the CM procedure (35) provides opportunities to draw for prizes for meeting the target goal.

    Although behavioral treatment methods have been found effective with opioid-dependent individuals, findings from research combining buprenorphine pharmacotherapy with different types of behavioral treatments are mixed. Bickel and colleagues (36) found that community reinforcement therapy with reinforcers for opioid-negative toxicology tests was associated with longer retention (p=0.03) and higher rates of abstinence (p=0.03) compared to a standard treatment group in a 26-week outpatient opioid detoxification study. Conversely, no differences in any drug use outcome were found between a voucher-based reinforcement group (n=20) and yoked control group that received no performance reinforcers (n=21)(37) in polydrug cocaine- and
    opioid-dependent participants.

    As for the “opt out of life” comment. It fits with our small program’s anecdotal experience. We’ve had scores of families and clients seeking detox from buprenorphine because, while it reduced opioid misuse, the ORT patient hadn’t re-entered life. They weren’t working or in school, they were hiding in the basement playing video games, little social interaction, etc.

  3. BTW – Regarding harsh and judgmental approaches, knowing that physicians enjoy terrific outcomes with abstinence-based treatment, some people might say that a physician assuming that non-physican opioid addicts are incapable of abstinence-based recovery is harsh and judgmental.

    • Can you send me that study you often reference re: opioid-dependent physicians?
      I know of several physicians who got sober with suboxone.
      Bottom line, for me, is that outcomes improve are greatly improved with the aid of opioid-replacement meds. I don’t know of a single study that shows abstinence-based Tx to be as effective. The informed consent argument is as simple as informing clients of the fact that these meds are out there and have a long, proven track record. However, they are nothing more than a tool to be placed in the client’s toolbox and assist them in their overall recovery.

      • Here are a few references.

        First though, one of the dismissals of physician recovery program outcomes is that physicians are different. Note that they have high rates of opiate addiction, prior treatments and co-morbidity. It’s also reported that their addiction tends to go undetected longer than most addicts and is, therefore, more advanced. They have easy access to drugs and often have staff and family to protect protect them from consequences of their addiction. In short, for every reason they may be easier to treat, there’s another reason that they may be harder to treat.

        DuPont et al. report on Physician Heath Program outcomes from 904 physicians in 16 states.

        In their lit review, they report:

        …addicted physicians treated within the PHP framework have the highest long-term recovery rates recorded in the treatment outcome literature: between 70% and 96%.

        They describe the kind of treatment addicted physicians receive this way:

        The first phase of formal addiction treatment for two thirds of these physicians (69%) was residential care often for 90 days. The remaining 31% began treatment in an intensive day treatment setting. The participants at this stage usually received multiple intensive sessions of group, individual, and family counseling as well as an introduction to an abstinence-oriented lifestyle through required attendance at Alcoholics Anonymous (AA), Narcotics Anonymous (NA), and Caduceus meetings (a collegial support association for recovering health professionals) and other mutual-aide community groups. Frequent status reports on treatment progress were required by most PHPs.

        Use of pharmacotherapy as a component of treatment for SUDs was rare. Very few of the treatment programs or the medical directors of the PHPs used any of the available maintenance or antagonist medications.

        After completion of initial formal addiction treatment, all PHPs developed a continuing care contract with the identified physician consisting of support, counseling, and monitoring for usually 5 years. Most PHPs (95%) also required frequent participation in AA, NA, or other self-help groups and verification of attendance at personal counseling and/or Caduceus meetings.

        Physicians were tested randomly throughout the course of their PHP care, typically being subject to testing 5 of 7 days a week.

        Physicians were typically tested an average of four times per month in the first year of their contracts for a total of about 48 tests in the year. By the fifth year, the average frequency of testing was about 20 tests per year.

        Participant characteristics included:

        The primary drugs of choice reported by these physicians were alcohol (50%), opiates (33%), stimulants (8%), or another substance (9%). Fifty percent reported abusing more than one substance, and 14% reported a history of intravenous drug use. Seventeen percent had been arrested for an alcohol or drug-related offense, and 9% had been convicted on those charges. Thirty-nine percent had a prior experience in addiction treatment, and 14% had experienced disciplinary action by their licensing agency prior to this episode of care.

        The only info on co-morbidity is this:

        About a third (32%) were prescribed an antidepressant for comorbid depression or anxiety disorders.

        In another article, DuPont et al. surveyed PHP programs in 49 states to find out what they look like:

        Goals [emphasis mine]:

        All responding PHPs shared the common goals of early detection of SUDs, thorough assessment and evaluation of potential cases, referral to abstinence-based treatment, longterm contingency monitoring, and reporting monitoring results to credentialing agencies (i.e., medical groups, hospitals, malpractice companies, health insurance companies, and so on) concerned with assuring that physicians are able to practice with reasonable skill and safety. There was essentially complete uniformity of these goals across all surveyed programs.

        Problems at admission:

        The most common primary drugs of abuse were alcohol (50%) and opioids (35%). The other 15% of cases reported stimulants, sedatives, marijuana, and other drugs. Across PHPs, an average of 31% of these physicians had problems with both drugs and alcohol. Programs reported that about half (48%) also had co-occurring psychiatric disorders and/or pain problems.

        Treatment:

        The first phase of formal addiction treatment for two thirds of these physicians (69%) was residential care often for 90 days. The remaining 31% began treatment in an intensive day treatment setting. The participants at this stage usually received multiple intensive sessions of group, individual, and family counseling as well as an introduction to an abstinence-oriented lifestyle through required attendance at Alcoholics Anonymous (AA), Narcotics Anonymous (NA), and Caduceus meetings (a collegial support association for recovering health professionals) and other mutual-aide community groups. Frequent status reports on treatment progress were required by most PHPs.

        Pharmacotherapy:

        Use of pharmacotherapy as a component of treatment for SUDs was rare. Very few of the treatment programs or the medical directors of the PHPs used any of the available maintenance or antagonist medications. On the other hand, PHPs indicated that as many as one third of participating physicians received antidepressant and nonbenzodiazepine antianxiety medications during their care.

        Long-term support and monitoring:

        After completion of initial formal addiction treatment, all PHPs developed a continuing care contract with the identified physician consisting of support, counseling, and monitoring for usually 5 years. Most PHPs (95%) also required frequent participation in AA, NA, or other self-help groups and verification of attendance at personal counseling and/or Caduceus meetings.

        Mayo Clinic Proceedings also has a review of treatment for addicted physicians.

        Mayo Clinic Proceedings has another article on the use of buprenorphine with health care professionals.

        When considering all of the aforementioned issues with buprenorphine diversion, it does not seem reasonable to prescribe this medication to an HCP (Health Care Professional) with a history of opioid addiction. After carefully considering the evidence, we believe that opioid-substitution therapy with buprenorphine is not a reasonable choice for this particular patient population. HCPs are engaged in safetysensitive work that requires vigilance and full cognitive function. We therefore recommend abstinence-based recovery until studies with this specific HCP population performed in a simulated health care environment document that highly safety-sensitive tasks can be performed without deterioration in performance.

        They also published an editorial that had a couple of complaints about the article but said:

        Hamza and Bryson recommend against buprenorphine maintenance for HCPs with opioid dependence. Instead, they support abstinence-based recovery consistent with the current standard utilized by PHPs. With such standards, several PHPs have demonstrated the lowest relapse rate ever reported in the literature.10 Such high success rates among HCPs are related to multiple factors, including the individual’s motivation to maintain licensure and professional practice, the extensive treatment provided to this group, and the long-term monitoring established by state PHPs.11 In fact, one can clearly make the argument that reported success rates are so high that introducing opioid maintenance to this paradigm would not be appropriate. Individual and large collaborative studies of state PHPs have demonstrated that under ideal circumstances, 80% of physicians being monitored for the 5 years after abstinence-based, 12-step treatment do not have a single relapse.12 Will an institutional review board ever approve a study comparing buprenorphine maintenance with this form of treatment? Can buprenorphine maintenance be justified in the face of such data?

        We agree wholeheartedly with Hamza and Bryson that caution is needed in decisions associated with the use of buprenorphine maintenance among HCPs returning to the health care workplace. The foundation information required to make good decisions regarding this medication in this population working in safety-sensitive positions is lacking. The use of a medication that has the potential to undermine cognitive function in HCPs working in an emergency or critical patient care setting cannot be supported at this time, given the lack of evidence of efficacy in this population and the absence of adequate national standards for its use.

      • One more link. Not scholarly, but germane and thought-provoking:

        From the ASAM blog:

        …is there any evidence that the general public requires less treatment than do healthcare professionals and pilots? I would further ask, given the excellent outcomes generally obtained by PHPs and pilot recovery programs, why there have been no studies in which members of the lay public go through identical programs to determine what their long term outcome would be. Indeed, what happens when a non-healthcare professional or non-pilot goes through 90 days of rehab, and is then followed regularly by an addiction specialist physician while simultaneously attending twelve-step or similar self-help groups and being subject to random urine drug testing, all as the FAA requires of pilots requesting a special issuance medical, and as state medical boards generally require of physicians wanting to return to practice? Would they too have an 80-90% recovery rate?

      • I thought this Fix.com article on the subject was interesting – made me rethink my idea of PHPs:
        http://www.thefix.com/content/whats-wrong-with-addicted-doctor-PHP-programs00389?page=all

        I wouldn’t say that doctors are inherently special – and that they, too, should have access to maintenance. One thing to keep in mind, however, is that higher education level, social and familial supports, and threat of serious career and financial consequences are all things that are highly correlated with successful outcomes.
        The average opioid treatment client doesn’t have all of these things going for him/her. Any tool that we can give them that helps increase their chances of success is a good thing – and something we should feel obligated to provide.

  4. We’re in agreement that, from a treatment perspective, I have no interest in forcing anything on anyone. If a patient prefers ORT, I have no interest in getting in their way.

    The bottom line is that PHPs appear to work better than anything else we have and we fail to offer that model to other opioid addicts. And, we maintain this two-tier treatment model with an assumption of physician-exceptionalism. I find that troubling and unpersuasive. Are physicians generally better patients with better outcomes?

    Regarding the article on PHPs, I’m all for researching the mechanisms of change in PHPs. Maybe they can be trimmed down or substitutions could be identified for particular mechanisms of change. However, the article reads like a rejection of evidence in favor of a search for evidence to support a preferred conclusion.

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