Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation
Key facts
- Who runs it
- University of California, San Francisco
- Where
- San Francisco, United StatesSee the site
- Trial code
- Status
- Not yet recruiting
- Phase
- Phase 4
- People taking part
- 50 people, planned
- Started
- Nov 2026
- Expected to end
- Jul 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Injectable buprenorphine
- Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
- Record updated
- 10 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Methadone-positive urine drug screening at baseline
- Buprenorphine-positive urine drug screening at baseline
- 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)
- Currently nursing, pregnant, or anticipating pregnancy in the next 6 months
- 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
Where in United States
- San Francisco Outpatient Buprenorphine Induction ClinicSan Francisco, United StatesContact: Tricia Wright, MDNot yet recruiting
About the trial
What the trial wants to find out
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:
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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.
The 2 groups in the trial
- Low-dose initiation (LDI)Existing treatment, for comparison
Participants start 0.5mg sublingual buprenorphine (Subutex) and gradually increase by 0.5-1.0mg daily for 7 days
Treatment: Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
- Direct-to-inject (DTI)Treatment being tested
Participants receive 8-32mg long-acting injectable buprenorphine (Brixadi or Sublocade) on day 1, followed by monthly injections as discussed with the provider
Treatment: Injectable buprenorphine
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Improving Buprenorphine Initiation Among Individuals With Opioid Use Disorder Using Fentanyl
- Record updated
- 10 November 2026