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Comparing Buprenorphine Initiation Methods for Fentanyl Use Disorder

This study is comparing two ways to start buprenorphine treatment for opioid use disorder (OUD) in people who use fentanyl. You would be randomly assigned to receive either injectable buprenorphine (Brixadi or Sublocade) starting with a higher dose on day one, or sublingual (under the tongue) buprenorphine (Suboxone, Zubsolv, or generic tablets) starting with a very low dose and increasing it over time. The goal is to see which method helps people stay in treatment longer and which is more satisfying, with fewer withdrawal symptoms and cravings. To join, you must be at least 18, have an OUD diagnosis, and have used fentanyl daily for at least 5 of the past 7 days, confirmed by a urine test.

Study design
This is a randomized controlled trial comparing two treatment strategies. It plans to enroll 50 participants.
What's involved
You would be randomized to one of two buprenorphine initiation protocols. You would also keep a diary of craving and withdrawal symptoms for the first 7 days after starting treatment.
Compensation
Not stated in the trial record.
Follow-up
The study will measure continuous retention in outpatient buprenorphine treatment at 90 days and self-reported satisfaction at 7 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07469501

Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation

Not Yet Recruiting
PHASE4Ages 18+InterventionalTreatment
University of California, San Francisco
~50 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:Injectable buprenorphineSublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Continuous retention in outpatient buprenorphine treatment by day 90
Measured over 90 days
+1 more outcome measured

Conditions

Opioid Use Disorder
Fentanyl

Explore related trials

Opioid Use Disorder

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Leslie W Suen, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Leslie W Suen, MD
[email protected]
628-206-6007
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 18 years of age at Visit 1.
Documentation of an OUD diagnosis as evidenced by meeting two or more of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) Criteria for Opioid Use Disorder
Self-reported daily use of fentanyl ≥ 5 out of the past 7 days at baseline,
Fentanyl-positive urine drug screening at baseline,
Interest in stopping or reducing fentanyl use,
Publicly insured through San Francisco Medicaid or Medicare and therefore able receive buprenorphine prescription dispensing through Community Behavioral Health Services (CBHS) Pharmacy

Exclusion

Currently nursing, pregnant, or anticipating pregnancy in the next 6 months
Methadone-positive urine drug screening at baseline
Buprenorphine-positive urine drug screening at baseline
Be unable to provide any locator or contact information at least one contact in addition to themselves
Any pending legal action that could prevent participation in study activities
Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data (e.g., acute psychosis), or cognitive impairment (e.g., dementia)

What this trial measures

  • Continuous retention in outpatient buprenorphine treatment by day 9090 days

    Receiving continuous treatment with buprenorphine sublingual prescriptions or injections administrations during the 90 days of follow up post-randomization as intended-to-treat. A period without buprenorphine treatment ≥8 days will be considered treatment discontinuation. Number of days of continuous treatment with the site clinician prescribing sublingual or injectable buprenorphine treatment during the 90 days post-randomization among RCT participants

  • Self-reported protocol satisfaction at day 77 days

    Patient-reported satisfaction with buprenorphine initiation protocol measured by Likert-scale satisfaction survey administered on day 7 follow-up visit