drugset / Trial / NCT06086275

Oral Buprenorphine as a Novel Low-dose Induction Strategy for Opioid Use Disorder

NCT06086275

RandomizedCrossoverOpen-labelOther

Summary

This is a human laboratory-based, randomized, cross-over study in which buprenorphine will be administered to healthy volunteers (n=22) in 3 separate inpatient 2-night visits, at least 1 week apart. At each visit, the participant will receive a single dose buprenorphine, either 0.15mg IV, 8mg PO, or 16mg PO. The order for the first dose administered will be fixed to the IV dose, and the subsequent doses will be randomized and counterbalanced to 8mg or 16mg PO. Participants will be given naltrexone to produce opioid blockade to eliminate the risk for opioid dependence in individuals without OUD. Timed blood samples will be collected up to 24 hours.

Timeline

Start
2024-06-04
Primary completion
2025-10-01
Completion
2025-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 0.15 mg Intravenous
Subject Buprenorphine Other / unclassified 8 mg Intravenous
Subject Buprenorphine Other / unclassified 16 mg Intravenous