Naltrexone for Overdose Prevention

This study is testing if an injectable medicine called naltrexone (380mg, given every 4 weeks) can help prevent fentanyl overdose in people who use stimulants like cocaine or methamphetamine. Researchers want to understand how well naltrexone works for overdose prevention and any challenges in using it. They also want to learn how often people who use stimulants are exposed to opioids without meaning to. You might be able to join if you are 18 or older, at risk for or living with HIV, use stimulants, and speak English. The study will compare naltrexone to usual care, which includes harm reduction supplies and naloxone (a medicine to reverse overdose). The main goal is to see how acceptable naltrexone is as a prevention method over 6 months.

Study design
This is a pilot randomized controlled trial with 100 participants. Participants will be randomly assigned to either receive naltrexone or usual care.
What's involved
You would have monthly assessments over 24 weeks, followed by a final study visit at 32 weeks. This includes urine and hair tests to check for fentanyl/opioid exposure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 32 weeks, with the primary endpoint measured at 6 months.

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NCT06633900

Naltrexone for Overdose Prevention

Recruiting
PHASE2Ages 18+InterventionalPrevention
University of California, San Francisco
~100 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:IM naltrexoneUsual Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acceptability
Measured over 6 months
Overdose Accidental
1 sites across 1 states
California1
  • Ayesha Appa, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

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  • Acceptability6 months

    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.