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Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia
Sponsor: Vanderbilt University Medical Center
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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2023-10-19
Completion Date
2028-02
Last Updated
2026-01-12
Healthy Volunteers
Yes
Conditions
Interventions
Buccal Buprenorphine 300 mcg
buprenorphine for 300mcg buccal administration
Buccal Buprenorphine 600 mcg
buprenorphine for 600mcg buccal administration
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.
Buccal Placebo
Placebo for buccal administration
Oral Placebo
Placebo for oral administration
Oral immediate-release oxycodone 10mg
Immediate-release oxycodone for 10 mg oral administration
Buccal Buprenorphine 450mcg
buprenorphine for 450mcg buccal administration. Note: This arm has been added to replace the 900mcg buprenorphine buccal administration arm.
Locations (1)
Vanderbilt University Medical Center
Nashville, Tennessee, United States