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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Naltrexone for Overdose Prevention
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ayesha Appa, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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What this trial measures
- 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.