Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia (NCT05988710)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (17 items).
Location: Vanderbilt University Medical Center — Nashville, Tennessee
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Liver/kidney disease
- Chronic pain
- Current/prior substance use disorder
- Pregnancy (to avoid fetal drug exposure, with pregnancy tests conducted to confirm eligibility)
- Seizure disorder
- Certain psychiatric conditions (severe depression, bipolar disorder, psychotic disorders)
- Recent use of medications that may interfere with study drug metabolism
- Recent benzodiazepine or opioid use (confirmed via rapid urine screening prior to each lab session)
- The presence of any medical conditions felt by the study physician to render participant unsafe
- Prior allergic reaction or intolerance to oxycodone, buprenorphine, or their analogs (explicitly including moderate-to-severe nausea or vomiting with prior opioids)
- Recent use of marijuana, delta-8 THC, CBD, and similar products
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Vanderbilt University Medical Center — Nashville, Tennessee
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.