Status:
RECRUITING
A Clinical Trial Comparing Buprenorphine Formulations for High Potency Synthetic Opioid Use
Lead Sponsor:
Rachel R. Luba
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Use Disorder
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
The goal of this clinical trial is to compare buprenorphine formulations (sublingual buprenorphine versus long-acting injectable buprenorphine) for treating opioid use disorder among individuals who u...
Eligibility Criteria
Inclusion Criteria:
- Aged 18 to 65
- Voluntarily seeking treatment for opioid use disorder (OUD)
- Consistent use of fentanyl or other high potency synthetic opioids
- Meets DSM-5 criteria for OUD with at least moderate severity
- Able to provide written informed consent in English and willing to comply with study procedures
Exclusion Criteria:
- Meets DSM-5 criteria for another substance use disorder as the primary diagnosis
- Has an active, unmanaged psychiatric condition that would make participation hazardous (e.g., acute, psychosis, current suicidality, current manic episode)
- Has an active, unmanaged medical condition that would make participation hazardous or preclude use of buprenorphine or ancillary medications for withdrawal (e.g., unmanaged hypertension, unmanaged diabetes, clinically significant abnormality on ECG, acute hepatitis)
- Buprenorphine or methadone treatment in the past 30 days
- Known allergy, hypersensitivity or intolerance to buprenorphine
- Pregnancy, lactation, or unwillingness to use adequate contraceptive methods
- Current physiological dependence on sedative-hypnotics or alcohol that would require medically supervised detoxification
- Liver function tests > 2x the upper limit of normal
- Use of medications or herbal products with known CYP3A4 inhibition or induction properties in the past 30 days
Key Trial Info
Start Date :
August 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06726200
Start Date
August 1 2026
End Date
January 15 2029
Last Update
March 4 2026
Active Locations (1)
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1
Substance Treatment and Research Service
New York, New York, United States, 10019