drugset / Trial / NCT05988710

Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia

NCT05988710

RandomizedCrossoverDouble-blindOther

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.

Timeline

Start
2023-10-19
Primary completion
2028-01
Completion
2028-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 300 ug Other
Subject Buprenorphine Other / unclassified 450 ug Other
Subject Buprenorphine Other / unclassified 600 ug Other
Subject Buprenorphine Other / unclassified 900 ug Other
Comparator Oxycodone Other / unclassified 10 mg Oral