RecruitingPhase 2Phase 3NCT06633900

Naltrexone for Overdose Prevention

Extended-Release Naltrexone as Opioid Overdose Pre-Exposure Prophylaxis (PrEP) in People Using Stimulants Living With or At Risk of HIV


Sponsor

University of California, San Francisco

Enrollment

100 participants

Start Date

Apr 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether naltrexone, a medication used to reduce cravings, can help prevent drug overdoses in people who use stimulants (such as cocaine, meth, or amphetamines) and are at risk for or living with HIV. Stimulant use can impair judgment and increase risky behavior, and this trial explores whether naltrexone can reduce that harm. **You may be eligible if...** - You are 18 or older - You are at risk for HIV or are living with HIV - You have a stimulant use disorder, or have used cocaine, amphetamine, or methamphetamine at least 10 days per month in the past 6 months - You speak English and can provide informed consent **You may NOT be eligible if...** - You currently use opioids (including being prescribed them) or have a new opioid use disorder - You received a long-acting naltrexone injection in the past 30 days - You have planned surgery in the next 6 months - You have moderate to severe liver disease - You are pregnant or breastfeeding - You have a serious bleeding disorder or take blood thinners - You have a known allergy to naltrexone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIM naltrexone

The study drug is an intramuscular injection of naltrexone (380mg), administered every 4 weeks via an injection in the ventrogluteal region.

BEHAVIORALUsual Care

Participants assigned to usual care will receive a harm reduction bundle in clinic. It will include the following components: 1) intranasal naloxone 4mg x 2, 2) participant choice of safer consumption kits based on substances and route used (specific materials for inhaled use vs. injecting, based on common use practices in the region), 3) fentanyl test kits with 2 lateral flow assays per package along with instructions to minimize false positive results, and 4) information about universal overdose precautions (behavioral modifications to optimize safety like using in the presence of others, use a test dose of new substances, etc.)


Locations(1)

Center on Substance Use and Health

San Francisco, California, United States

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NCT06633900


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