Injectable versus sublingual buprenorphine for people using fentanyl and other potent synthetic opioids
A Randomized Controlled Trial Examining Extended-Release Injectable Buprenorphine in Those Who Use High Potency Synthetic Opioids
EARLY_PHASE1 · Columbia University · NCT06726200
This project will test whether a long-acting injectable buprenorphine or daily sublingual buprenorphine/naloxone works better at reducing drug use and preventing relapse in adults who use fentanyl or other high‑potency synthetic opioids.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Columbia University (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06726200 on ClinicalTrials.gov |
What this trial studies
This early-phase interventional study compares two buprenorphine approaches—sublingual buprenorphine/naloxone and a long-acting injectable buprenorphine—in adults aged 18–65 who consistently use fentanyl or other high-potency synthetic opioids. Participants receive one of the formulations and are followed to measure frequency of drug use and sustained relapse after treatment initiation. The protocol also collects body composition and self-reported fentanyl use data and measures early blood levels of buprenorphine and norbuprenorphine to see how these factors relate to outcomes. Craving and opioid withdrawal symptoms will be tracked to explore their influence on treatment response.
Who should consider this trial
Good fit: Adults 18–65 with at least moderate DSM-5 opioid use disorder who are actively using fentanyl or other high-potency synthetic opioids, seeking treatment, and able to provide informed consent in English are the intended participants.
Not a fit: People recently treated with buprenorphine or methadone (within 30 days), those who are pregnant, allergic to buprenorphine, or who have unmanaged psychiatric or medical conditions or a different primary substance use disorder may be excluded or unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could show which buprenorphine formulation better reduces ongoing drug use and relapse among people using fentanyl, guiding more effective treatment choices.
How similar studies have performed: Long-acting injectable buprenorphine has shown benefits in broader opioid use disorder populations, but there is limited direct evidence specifically focused on fentanyl and other high-potency synthetic opioids.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Substance Treatment and Research Service — New York, New York, United States (RECRUITING)
Study contacts
- Study coordinator: Rachel Luba, PhD
- Email: RRL2117@CUMC.Columbia.edu
- Phone: 646-774-8189
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Opioid Use Disorder