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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• at-risk for HIV or living with HIV

• stimulant use disorder (by DSM-V) or positive urine drug test for cocaine, amphetamine, or methamphetamine in last 6 months AND report at least 10 days of stimulant use/month,

• able to provide informed consent,

• English-speaking,

• age 18 years old or greater.

Locations
United States
California
Center on Substance Use and Health
RECRUITING
San Francisco
Contact Information
Primary
Ayesha Appa, MD
ayesha.appa@ucsf.edu
628-206-7839
Backup
Xochitl Luna Marti, MPH
xochitl.lunamarti@sfdph.org
628-217-6235
Time Frame
Start Date: 2025-04-10
Estimated Completion Date: 2027-04-15
Participants
Target number of participants: 100
Treatments
Experimental: Intervention
Participants assigned to the intervention arm will receive naltrexone injections once a month over 6 months. The naltrexone injection (380mg) will be administered every 4 weeks in the ventrogluteal location.
Active_comparator: Control
Participants in the control arm will receive usual care.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco
Collaborators: National Institute on Drug Abuse (NIDA)

This content was sourced from clinicaltrials.gov