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

• Status: Not yet recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: University of Utah
• Treatments: Buprenorphine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• DSM-5 diagnosis of any substance use disorder excluding tobacco.

• Presence of any alcohol, cannabis, opioids (including methadone, buprenorphine) or any other illicit substances on urine toxicology at any study visit, including cocaine, amphetamines, and benzodiazepines.

• Receiving treatment with opioid analgesic in last 60 days, or anticipate requiring opioids during the proposed trial, or up to 30 days after the trial completion

• Baseline PHQ-9 or GAD7 > 10 (i.e. moderate depression/anxiety)

• History of chronic pain

• Psychotic disorder, active suicidality or homicidally, or any psychiatric condition that impair ability to provide informed consent.

• History of hypersensitivity or allergy to buprenorphine or naltrexone

• Pregnant or breastfeeding.

• Liver function test greater than 3 times upper normal limit.

• Receiving medications that are strong or moderate CYP34A inducers or inhibitors (including but not limited to ketoconazole, itraconazole, clarithromycin, fluconazole, erythromycin), in the past 30 days.