Naltrexone + Ecological Momentary Intervention for Methamphetamine Addiction

Recruiting in Palo Alto (17 mi)

Overseen ByGlenn-Milo Santos, PhD, MPH

Age: 18+

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, San Francisco

Prior Safety Data

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?This trial tests a treatment combining as-needed naltrexone with a real-time reminder system. It targets MSM who use meth due to their high risk of HIV and lack of effective treatments. Naltrexone reduces cravings and meth's effects, while reminders help ensure timely medication use. Naltrexone has been used for opioid dependence and has shown effectiveness in reducing cravings and preventing relapse.

Eligibility Criteria

This trial is for cisgender male methamphetamine users aged 18-70 who have sex with men, are interested in reducing their meth use, and do not have severe medical or psychiatric conditions. Participants must not be using opioids or have severe liver disease.

Inclusion Criteria

I've had unprotected sex or missed HIV prevention/treatment doses due to meth use in the last 3 months.

My CD4 count is above 200, or between 100-199 with a low HIV viral load.

I am a cisgender male.

Exclusion Criteria

My kidney function is reduced.

I am currently using opioids or have a condition that might need them.

My liver tests are more than 3 times the normal limit.

Participant Groups

The study tests if intermittent oral naltrexone (50 mg), enhanced by a real-time mobile intervention platform, is more effective than placebo in helping reduce meth use over a 12-week period among men who have sex with men.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Naltrexone with ecological momentary interventionExperimental Treatment2 Interventions

Naltrexone Hydrochloride, 50 mg., intermittent with ecological momentary assessment (EMA)

Group II: Placebo with ecological momentary interventionPlacebo Group2 Interventions

Placebo, intermittent with ecological momentary assessment (EMA)

Naltrexone Hydrochloride is already approved in United States, United States, United States, European Union for the following indications:

🇺🇸 Approved in United States as ReVia for: