NCT05988710

Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Analgesia
• Abuse Opioids
• Pain

Interventions

Type	Name	Description
DRUG	Buccal Buprenorphine 300 mcg	buprenorphine for 300mcg buccal administration
DRUG	Buccal Buprenorphine 600 mcg	buprenorphine for 600mcg buccal administration
DRUG	Buccal Buprenorphine 900 mcg	buprenorphine for 900mcg buccal administration. Note: This arm has been discontinued as of 06/25/2024 and has been replaced with the 450mcg buprenorphine buccal administration arm.
DRUG	Buccal Placebo	Placebo for buccal administration
DRUG	Oral Placebo	Placebo for oral administration
DRUG	Oral immediate-release oxycodone 10mg	Immediate-release oxycodone for 10 mg oral administration
DRUG	Buccal Buprenorphine 450mcg	buprenorphine for 450mcg buccal administration. Note: This arm has been added to replace the 900mcg buprenorphine buccal administration arm.

Timeline

• Start date: 2023-10-19
• Primary completion: 2028-01-01
• Completion: 2028-02-01
• First posted: 2023-08-14
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study