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Peer-reviewedCC BY-NC-ND 4.0Drug and Alcohol Dependence Reports

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

4 affiliations
  1. 1Department of Psychiatry, Harvard Medical School, Boston, MA, United States
  2. 2Center for Mindfulness and Compassion, Cambridge Health Alliance, Cambridge, MA, United States
  3. 3Health Evaluation Research Lab, Cambridge Health Alliance, Cambridge, MA, United States
  4. 4Department of Behavioral Health Science & Practice, University of South Florida, United States

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/recurrence of use 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.

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BibTeX
@article{schumanolivier2026controlling,
  title = {{Controlling and monitoring buprenorphine dosing does not benefit treatment engagement and adherence during the post-detoxification period - A pilot randomized controlled trial}},
  author = {Zev Schuman-Olivier and Grace Janzow and Michael William Flores and Amanda Sharp and Cassandra Harding and Khary K. Rigg and Holly Hills and Kathleen A. Moore},
  journal = {Drug and Alcohol Dependence Reports},
  year = {2026},
  month = oct,
  doi = {10.1016/j.dadr.2026.100487},
  url = {https://doi.org/10.1016/j.dadr.2026.100487},
  note = {CC BY-NC-ND 4.0},
}
RIS
TY  - JOUR
TI  - Controlling and monitoring buprenorphine dosing does not benefit treatment engagement and adherence during the post-detoxification period - A pilot randomized controlled trial
AU  - Zev Schuman-Olivier
AU  - Grace Janzow
AU  - Michael William Flores
AU  - Amanda Sharp
AU  - Cassandra Harding
AU  - Khary K. Rigg
AU  - Holly Hills
AU  - Kathleen A. Moore
PY  - 2026
DA  - 2026/10/23
JO  - Drug and Alcohol Dependence Reports
DO  - 10.1016/j.dadr.2026.100487
UR  - https://doi.org/10.1016/j.dadr.2026.100487
AB  - 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/recurrence of use 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.
SN  - 2772-7246
ER  -