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NCT07469501 · ClinicalTrials.gov registry record · Phase 4
Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation
A Phase 4 study, sponsored by University of California, San Francisco.
- Not yet
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
NCT07469501 is a Phase 4 study that has not yet begun recruiting, run by University of California, San Francisco. The registered enrollment target is 50 participants.
The verdict
NCT07469501, a Phase 4 study, has not yet begun recruiting, sponsored by University of California, San Francisco.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
- DRUG Injectable buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-06 |
| Est. Completion | 2027-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07469501
The ClinicalTrials.gov registry entry for NCT07469501 describes a study currently listed as not yet recruiting, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets) is the first listed.
NCT07469501 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07469501 about?
NCT07469501 is a clinical study titled "Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation". 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...
What is the current status of trial NCT07469501?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2026-06. Estimated completion is 2027-05.
What interventions are being tested in trial NCT07469501?
The interventions under investigation include: Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets) (DRUG), Injectable buprenorphine (DRUG).
Who is sponsoring clinical trial NCT07469501?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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