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Controlling and monitoring buprenorphine dosing does not benefit treatment engagement and adherence during the post-detoxification period - A pilot randomized controlled trial

Year: 2026
Type: article
Abstract: Background Some prescribers with concerns about buprenorphine diversion insist on observed dosing protocols. This study compared the traditional MySafeRx Inspire protocol of daily, observed medication administration via videoconference paired with synchronous medication delivery from an electronic dispenser (Plus) with a more flexible protocol in which patients started treatment with access to medications anytime from a passcode lockbox (Flex) . Flex patients were told they would receive an electronic dispenser with supervised administration if signs of diversion/relapse occurred. Methods This pilot randomized controlled trial provided daily motivational coaching and supervised buprenorphine self-administration with adults with opioid use disorder (OUD) randomized to Plus (n=9) or Flex (n=10). Treatment retention, opioid toxicology, acceptability, and medication engagement were measured. Results The Flex arm exhibited high Buprenorphine/Naloxone (B/N) treatment retention (Week-12:70% vs. 22% [ Plus ]). Flex participants exhibited non-significantly greater abstinence by negative opioid urine toxicology tests (47% vs. 18%). More participants were satisfied ( > 4 of 5) with the Flex intervention (50%) versus Plus (22%). After an interim analysis showed greater engagement in Flex , which received statistically significant more buprenorphine doses than Plus by week-5 ( p = 0.01), the study was halted. Conclusions This study suggests mandated daily supervised buprenorphine adherence during telemedicine medication for OUD (MOUD) is unnecessary when participants adhere to treatment. Daily supervised MOUD administration should be used only when clinically necessary, not by default. Initially trusting patients and providing motivational interviewing with the option to increase monitoring when needed is at least as good and may even increase treatment engagement and adherence.
Language: English
Field: Medicine
Open Access status: gold
Estimated APC paid: $2,120
OpenAlex ID: W7223368367
FWCI:
Cites: 49
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Related to: 10