Naltrexone for Overdose Prevention

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

April 10, 2025

Primary Completion Date

April 15, 2027

Study Completion Date

April 15, 2027

Conditions
Overdose Accidental
Interventions
DRUG

IM naltrexone

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

BEHAVIORAL

Usual 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.)

Trial Locations (1)

94102

RECRUITING

Center on Substance Use and Health, San Francisco

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

University of California, San Francisco

OTHER