Status:
COMPLETED
Oral Buprenorphine as a Novel Low-dose Induction Strategy for Opioid Use Disorder
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
University of Utah
Conditions:
Opioid Use Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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. A...
Detailed Description
The approach is to conduct a randomized, cross-over trial in a controlled human laboratory setting with healthy volunteers (n=22). After obtaining informed consent, eligible participants will be sched...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06086275
Start Date
June 4 2024
End Date
October 1 2025
Last Update
October 23 2025
Active Locations (1)
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1
Brigham and Women's hospital
Boston, Massachusetts, United States, 02115