Oral Buprenorphine as a Novel Low-Dose Induction Strategy for Individuals With Opioid Use Disorder

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• English-speaking adults aged 18 and above.

• In good physical health as determined by routine medical screening consisting of a complete physical exam, safety labs and EKG.

• Baseline vital signs with HR between 60 and 100, SBP between 90 and 160mmHg, and respiratory rate between 12 and 20 breaths per minute.

• Prior personal history of opioid use, therapeutic or non-therapeutic in past the 12 months.

Locations
United States
Massachusetts
Brigham and Women's hospital
RECRUITING
Boston
Contact Information
Primary
Joji Suzuki, MD
jsuzuki2@bwh.harvard.edu
6177325752
Time Frame
Start Date: 2024-06-04
Estimated Completion Date: 2026-03
Participants
Target number of participants: 22
Treatments
Experimental: 8mg PO buprenorphine
After the open-label period, the participant will receive 8mg PO, then 16mg PO will be administered in the following visit.
Experimental: 16mg PO buprenorphine
After the open-label period, the participant will receive 16mg PO, then 8mg PO will be administered in the following visit.
Experimental: 0.15mg IV Dose
The first dose administered will be fixed to an open-label 0.15mg IV dose.
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: University of Utah

This content was sourced from clinicaltrials.gov