The Prescription Opioid Treatment Study: What Have We Learned?

<li>Misuse of prescription opioid medications has emerged as a major public health challenge over the past two decades, and&nbsp;treatment of prescription opioid use disorders&nbsp;has become extremely common in response, with 746,000 patients receiving such treatment in 2013.
<li>Since its approval in 2002,&nbsp;buprenorphine-naloxone (bup-nx)&nbsp;has become a mainstay of pharmacotherapy for opioid use disorders.</li> <li>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.</li> The multi-site&nbsp;<a href="">Prescription Opioid Addiction Treatment Study (POATS)</a>&nbsp;(CTN-0030),&nbsp;conducted by the NIDA Clinical Trials Network, was&nbsp;the largest clinical trial yet conducted with patients dependent on prescription opioids&nbsp;(N=653).<br>
In addition to main trial results, the study yielded numerous secondary analyses, and included a&nbsp;<a href="">3.5-year follow-up study</a>&nbsp;(CTN-0030-A-3), the first of its kind with this population.<br>
This paper&nbsp;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.<br>
POATS examined combinations of buprenorphine-naloxone of varying duration and counseling of varying intensity.<br>
The study had several key results:<br>
<li>Similar to heroin users, the vast majority of prescription opioid users failed to achieve success after&nbsp;tapering off&nbsp;bup-nx, whereas about half of patients achieved successful outcomes while&nbsp;maintained&nbsp;on bup-nx.</li>
<li>The&nbsp;longer&nbsp;bup-nx taper&nbsp;(4 weeks instead of 1 or 2) was&nbsp;better both for maintaining abstinence and reducing withdrawal symptoms.</li>
<li>Predictors of better&nbsp;outcomes&nbsp;included never having used heroin, initial use of opioids to treat pain rather than to get high, and presence of major depressive disorder.</li>
<li>Patients who were randomized to receive additional&nbsp;opioid drug counseling&nbsp;in addition to standard medical management did not have improved outcomes.<br>
<li>Failure of bup-nx treatment was predictable from&nbsp;early performance&nbsp;— only 6% of participants who used opioids during the first 2 weeks of bup-nx treatment were abstinent in weeks 9-12.</li>
<li>Forty-two months after the trial started,&nbsp;61% of participants who entered the follow-up study had abstained&nbsp;from opioids in the previous month. A history of heroin use was the only predictor of poor month-42 outcomes.</li>
Conclusions: POATS was the&nbsp;first large-scale study&nbsp;of the treatment of prescription opioid dependence; its findings can influence both treatment guidelines and future.<br>
In particular, the results of POATS suggest&nbsp;support for an individualized approach to behavioral interventions&nbsp;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&nbsp;some patients would do well with just medical management and others should receive additional counseling.<br>
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<p>Weiss RD &amp; Rao V. The Prescription Opioid Addiction Treatment Study: What Have We Learned.&nbsp;<em>Drug and Alcohol Dependence</em>&nbsp;2017;173:S48-S54</p>