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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 4

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

50 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The goal of this pragmatic randomized controlled trial is to compare treatment outcomes of two strategies for initiating buprenorphine treatment (low-dose initiation and direct-to-inject) in adults with opioid use disorder (OUD) who use fentanyl. This study aims to:

1. Compare effectiveness of each strategy on treatment retention in a real world, clinical setting, and
2. Assess differences between strategies in patient-reported outcomes, including withdrawal symptoms, cravings, drug use, treatment satisfaction, and overall acceptability.

Participants will:

1. Be randomized to initiate buprenorphine via a low-dose initiation or direct-to-inject protocol at an outpatient buprenorphine clinic,
2. Keep a diary of craving and withdrawal symptoms for the first 7 days after initiation, and
3. Visit the outpatient clinic 7, 30, and 90 days after initiation for urinary drug screen and follow-up surveys.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• 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 Criteria:

• 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)

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

University of California, San Francisco

Study start

2026-11 Estimated

Primary completion

2028-07 Estimated

Study completion

2028-07 Estimated

First posted

Mar 13, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts