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Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia

StatusRecruiting
PhasePhase 4
Started2023-10-19
View on ClinicalTrials.gov ↗

Amendment history

2026-01-09
Study Status v6
Primary completion date2026-10→2028-01
Completion date2026-10→2028-02
2024-12-06
Study Status, Eligibility v5
Eligibility criteria+228 characters
[...] 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 Recent use of kratom Severe asthma Long QT syndrome Parkinson disease Weight <60 kg
2024-09-12
Study Status, Study Design v4
Enrollment target72→120
2024-07-08
Study Status, Arms and Interventions v3
Study arms5→6
InterventionsBuccal Buprenorphine 300 mcg (Drug), Buccal Buprenorphine 600 mcg (Drug), Buccal Buprenorphine 900 mcg (Drug), Buccal Placebo (Drug), Oral…→Buccal Buprenorphine 300 mcg (Drug), Buccal Buprenorphine 450mcg (Drug), Buccal Buprenorphine 600 mcg (Drug), Buccal Buprenorphine 900 mcg…
2023-10-26
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-11→confirmed 2023-10-19
Study sitesdetails revised at 1 of 1 site
2023-10-19
Study Status v1
Primary completion date2026-09→2026-10
Completion date2026-09→2026-10
Start date2023-09→2023-11
2023-08-08
Original filing
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.
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