New combo tackles meth cravings on demand
NCT ID NCT04791969
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether taking naltrexone pills only when needed, combined with a smartphone app that offers real-time support, can help men who have sex with men reduce methamphetamine use. Sixty participants were randomly assigned to receive either the drug or a placebo, plus the app, for 12 weeks. The goal was to see if the approach could lower meth-positive urine tests and improve HIV prevention behaviors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- naltrexone (a drug that blocks opioid receptors, used here to reduce meth cravings)
- What this could lead to
- If it works, this could offer a practical, on-demand treatment to help men who have sex with men cut down meth use and lower their risk of HIV.
- What could go wrong
- This is a small, early-phase trial with only 60 participants, so results may not apply to everyone. The drug is taken only as needed, which may not work for all users.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
60 people
The number who actually took part.
- Started
-
Dec 2021
- Finished
-
Jul 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * cisgender male (male gender and sex assigned at birth) * age 18-70 years\* (naltrexone's tolerability and safety has been demonstrated among older adults up to age 70) * self-reported condomless anal sex with men or missing Pre-Exposure Prophylaxis or antiretroviral therapy doses due to meth use in the prior three months while under the influence of meth * self-reported meth use at least weekly * mild, moderate or severe meth use disorder * positive meth sample via sweat patch or urine testing during screening * interested in reducing meth use * no current acute illness requiring prolonged medical care * no chronic illness that is likely to progress clinically during trial * able and willing to provide informed consent and adhere to visit schedule * current CD4 count ≥ 200 cells/mm3; or CD4 count of 100-199 cells/mm3 and HIV viral load \< 200 copies/mL (if living with HIV) * baseline complete blood count, total protein, albumin, glucose, alkaline phosphatase, creatinine, blood urea nitrogen test, and electrolytes without clinically significant abnormalities as determined by study clinician in conjunction with symptoms, physical exam, and medical history Exclusion Criteria: * any psychiatric (e.g., depression with suicidal ideation) or medical condition that would preclude safe participation * known allergy or prior adverse reaction to naltrexone * current use of any opioids or a known medical condition which currently requires or may likely require opioid analgesics * opioid-positive urine test at screen/enrollment visits (naltrexone can induce opioid withdrawal) * moderate or severe liver disease (aspartate aminotransferase test, alanine aminotransferase test, or total bilirubin \> 3 times upper limit of normal) * impaired renal function (creatinine clearance \< 60 ml/min) * currently participating in another intervention research study with potential overlap * severe alcohol use disorder as determined by structured clinical interview for DSM-5 criteria * any condition that, in the PI and/or study clinician's judgment interferes with safe participation or adherence to study procedures
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Methamphetamine use disorder are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
San Francisco Department of Public Health
San Francisco, California, 94102, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a diabetes and Weight-Loss drug help people quit meth?
- Can methadone clinics double as meth treatment centers?
- Brain zaps aimed at craving center could help break meth addiction
- Brain zaps synced to brain waves may curb meth cravings
- Can a single psilocybin dose help break meth addiction?
- Can a psychedelic help break meth addiction in people with HIV?