The Prescription Opioid Treatment Study: What Have We Learned?
Misuse of prescription opioid medications has emerged as a major public health challenge over the past two decades, and treatment of prescription opioid use disorders has become extremely common in response, with 746,000 patients receiving such treatment in 2013.
Since its approval in 2002, buprenorphine-naloxone (bup-nx) has become a mainstay of pharmacotherapy for opioid use disorders. However, because the approval of bup-nx derived from large-scale clinical trials conducted predominantly in heroin users, it was unclear the degree to which its use in those dependent on prescription opioids would yield similar outcomes.
The multi-site Prescription Opioid Addiction Treatment Study (POATS) (CTN-0030), conducted by the NIDA Clinical Trials Network, was the largest clinical trial yet conducted with patients dependent on prescription opioids (N=653).Similar to heroin users, the vast majority of prescription opioid users failed to achieve success after tapering off bup-nx, whereas about half of patients achieved successful outcomes while maintained on bup-nx.
The longer bup-nx taper (4 weeks instead of 1 or 2) was better both for maintaining abstinence and reducing withdrawal symptoms.
Predictors of better outcomes included never having used heroin, initial use of opioids to treat pain rather than to get high, and presence of major depressive disorder.
Patients who were randomized to receive additional opioid drug counseling in addition to standard medical management did not have improved outcomes.
In addition to main trial results, the study yielded numerous secondary analyses, and included a 3.5-year follow-up study (CTN-0030-A-3), the first of its kind with this population.
This paper summarizes the POATS design, main outcomes, predictors of outcome, subgroup analyses, the predictive power of early treatment response, and the long-term follow-up study.
POATS examined combinations of buprenorphine-naloxone of varying duration and counseling of varying intensity.
The study had several key results:
Failure of bup-nx treatment was predictable from early performance — only 6% of participants who used opioids during the first 2 weeks of bup-nx treatment were abstinent in weeks 9-12.
Forty-two months after the trial started, 61% of participants who entered the follow-up study had abstained from opioids in the previous month. A history of heroin use was the only predictor of poor month-42 outcomes.
Conclusions: POATS was the first large-scale study of the treatment of prescription opioid dependence; its findings can influence both treatment guidelines and future.
In particular, the results of POATS suggest support for an individualized approach to behavioral interventions in the context of buprenorphine-naloxone treatment of prescription opioid use disorders. The fact that some patients benefited from counseling (heroin users who attended sessions regularly, for example) suggests that some patients would do well with just medical management and others should receive additional counseling.
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Funding for this Addiction Science Made Easy project is provided by the Addiction Technology Transfer Center National Office, under the cooperative agreement from the Center for Substance Abuse Treatment of SAMHSA.
Articles were written based on the following published research:
Weiss RD & Rao V. The Prescription Opioid Addiction Treatment Study: What Have We Learned. Drug and Alcohol Dependence 2017;173:S48-S54