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NCT06633900 · ClinicalTrials.gov registry record · Phase 2
Naltrexone for Overdose Prevention
A Phase 2 study of Overdose Accidental, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06633900: Recruiting Phase 2 study of Overdose Accidental, sponsored by University of California, San Francisco.
NCT06633900 is a Phase 2 study of Overdose Accidental that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 100 participants, below the 181-participant average among 3 other Overdose Accidental trials with a reported enrollment target (45% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06633900, a Phase 2 study of Overdose Accidental, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to see if an injectable medicine called naltrexone can prevent fentanyl overdose deaths in people who use other drugs (cocaine, methamphetamine). The main questions it aims to answer are: What are the challenges for implementing naltrexone as an overdose prevention strategy? Are injections of naltrexone effective for opioid overdose prevention among people who use stimulants? How often are people who use stimulants and do not intentionally use opioids unintentionally exposed to opioids? Researchers will compare participants to receive the study medication to the usual care group to see if one group experiences fewer opioid overdose events than the other. Participants will be randomized to either receive a monthly injection of naltrexone over six months, or receive usual care. Usual care includes harm reduction supplies. Laboratory procedures will include the collection of urine, blood, and hair samples for various safety and outcome measure testing.
Primary Outcome
The primary outcome is the acceptability of IM naltrexone as opioid PrEP, which the study investigators will quantitatively assess via retention in treatment at 24 weeks and proportion of on-time injections during the study period. The investigators will consider 50% of enrolled participants completing 3 or more injections to meet a minimum standard of intervention uptake.
Conditions Studied
Interventions
- BEHAVIORAL Usual Care
- DRUG IM naltrexone
Study Locations (1)
California
- Center on Substance Use and Health - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-04-10 |
| Est. Completion | 2027-04-15 |
| Phase | Phase 2 |
What NCT06633900 shows while recruiting
NCT06633900 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 181-participant average among 3 other Overdose Accidental trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Overdose Accidental appearing as the primary indexed condition, and to 2 interventions - of which Usual Care is the first listed.
NCT06633900 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06633900 about?
NCT06633900 is a clinical study titled "Naltrexone for Overdose Prevention". The goal of this clinical trial is to see if an injectable medicine called naltrexone can prevent fentanyl overdose deaths in people who use other drugs (cocaine, methamphetamine). The main questions it aims to answer are: What are the challenges for implementing naltrexone as an overdose preventio...
What is the current status of trial NCT06633900?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2025-04-10. Estimated completion is 2027-04-15.
What conditions does trial NCT06633900 study?
This clinical trial studies the following conditions: Overdose Accidental.
What interventions are being tested in trial NCT06633900?
The interventions under investigation include: Usual Care (BEHAVIORAL), IM naltrexone (DRUG).
Who is sponsoring clinical trial NCT06633900?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06633900 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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