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Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 18 to 65

Injectable versus sublingual buprenorphine for people using fentanyl and other potent synthetic opioids

Official title: A Randomized Controlled Trial Examining Extended-Release Injectable Buprenorphine in Those Who Use High Potency Synthetic Opioids

Run by Columbia University · NCT06726200 · Data updated 2026-11-12

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.

More Opioid Use Disorder trials

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment60 (estimated)
SponsorColumbia University
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedFebruary 25, 2026
Main results expectedJanuary 15, 2029
Study endsJanuary 15, 2029
Registry record updatedJune 2, 2026
Trial IDNCT06726200 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Substance Treatment and Research Service
    New York, New York, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Opioid Use Disorder 579Columbia University 189
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.