Actively Recruiting
Naltrexone for Overdose Prevention
Led by University of California, San Francisco · Updated on 2026-05-01
100
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Naltrexone for Overdose Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At risk for HIV or living with HIV
- Stimulant use disorder by DSM-V or positive urine test for cocaine, amphetamine, or methamphetamine in last 6 months
- Report using stimulants at least 10 days per month
- Able to provide informed consent
- English-speaking
- Age 18 years or older
You will not qualify if you...
- Current prescribed or non-prescribed opioid use, including diagnosed opioid use disorder
- Received long-acting injectable naltrexone in past 30 days
- Planned surgery in next 6 months
- Moderate, severe, or chronic liver disease (AST, ALT ≥ 5 times upper limit or symptoms)
- Pregnant or breastfeeding
- Increased risk of bleeding (thrombocytopenia <50 x 10^9/L, coagulopathy, or anticoagulation therapy)
- Known allergy to naltrexone or its ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Center on Substance Use and Health
San Francisco, California, United States, 94102
Actively Recruiting
Research Team
A
Ayesha Appa, MD
CONTACT
X
Xochitl Luna Marti, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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