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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: Clinical Trial Phase 4 study, sponsored by University of California, San Francisco.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
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 |
What is known before NCT07469501 opens enrollment
NCT07469501 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets) is the first listed.
NCT07469501 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07469501's enrollment target sits among peer trials
50 1255th of 2000 higher than 678 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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