Clinical Trial

Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia

Recruiting Phase 4
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Summary
The goal of this study is to compare the abuse potential of low-dose equianalgesic buccal buprenorphine to a commonly used full mu opioid receptor (MOR) agonist in a highly controlled experimental setting. This is a translational study in which healthy participants are phenotyped for psychosocial and Opioid-Use-Disorder-risk-related metrics. In a within-subjects crossover design, 60 participants will receive a standard postoperative oral oxycodone dose (10 mg), placebo, and 3 different doses of buccal buprenorphine across 5 separate sessions. Quantitative Sensory Testing (QST) will be used to evaluate alterations in pain responsiveness relative to placebo across buprenorphine doses and oxycodone, and will compare abuse potential (indexed by the standard FDA drug liking metric) following equianalgesic doses of the two drugs.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-08-08; most recent amendment 2026-01-09.
Status change: Not Yet Recruiting → Recruiting 2023-10-26
Trial Details
NCT Number NCT05988710
Lead Sponsor Vanderbilt University Medical Center
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Analgesia, Abuse Opioids, Pain
Enrollment 120 participants
Start Date 2023-10-19
Primary Completion 2028-01 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2026-01-12