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Opioid Antagonist
Naltrexone + Ecological Momentary Intervention for Methamphetamine Addiction
Phase 2
Waitlist Available
Led By Glenn-Milo Santos, PhD, MPH
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
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)
Must not have
impaired renal function (creatinine clearance < 60 ml/min)
current use of any opioids or a known medical condition which currently requires or may likely require opioid analgesics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every four weeks from enrollment to the end of treatment at 12 weeks
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Naltrexone may cause side effects such as nausea, headache, dizziness, fatigue, sleep problems or irritability. It can also induce opioid withdrawal symptoms if participants are using opioids.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had unprotected sex or missed HIV prevention/treatment doses due to meth use in the last 3 months.
Select...
My CD4 count is above 200, or between 100-199 with a low HIV viral load.
Select...
I am a cisgender male.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is reduced.
Select...
I am currently using opioids or have a condition that might need them.
Select...
My liver tests are more than 3 times the normal limit.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every week from enrollment to the end of treatment at 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every week from enrollment to the end of treatment at 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Change in meth-positive urine tests from baseline to week 12 between Intermittent Oral Naltrexone vs. placebo groups
Secondary study objectives
Mean change in sexual risk behaviors from baseline to week 12 between Intermittent Oral Naltrexone vs placebo groups.
Other study objectives
Mean change in serum drug levels (PrEP) or ART suppression rates from baseline to week 12 between Intermittent Oral Naltrexone vs placebo groups.
Trial Design
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ecological Momentary Intervention
2020
N/A
~230
Naltrexone Hydrochloride
2021
Completed Phase 1
~330
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Naltrexone, an opioid receptor antagonist, works by blocking opioid receptors, which prevents the activation of these receptors by opioids. This mechanism can help reduce cravings and the rewarding effects associated with methamphetamine use.
For methamphetamine addiction patients, this is significant because it can decrease the reinforcing properties of methamphetamine, making it easier to reduce use and support recovery efforts.
Extended-release naltrexone for methamphetamine dependence among men who have sex with men: a randomized placebo-controlled trial.
Extended-release naltrexone for methamphetamine dependence among men who have sex with men: a randomized placebo-controlled trial.
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,562 Previous Clinical Trials
15,254,731 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,556 Previous Clinical Trials
3,255,241 Total Patients Enrolled
1 Trials studying Methamphetamine Addiction
8 Patients Enrolled for Methamphetamine Addiction
Glenn-Milo SantosLead Sponsor
2 Previous Clinical Trials
142 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had unprotected sex or missed HIV prevention/treatment doses due to meth use in the last 3 months.My kidney function is reduced.I do not have a chronic illness that will worsen during the trial.I am currently using opioids or have a condition that might need them.My liver tests are more than 3 times the normal limit.My CD4 count is above 200, or between 100-199 with a low HIV viral load.You have had an allergic reaction or negative response to naltrexone in the past.You have a problem with using methamphetamine, ranging from mild to severe.I do not have any mental health or medical conditions that would make it unsafe for me to participate.You use methamphetamine at least once a week and you have reported it yourself.You want to stop using methamphetamine.I am a cisgender male.I am between 18 and 70 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo with ecological momentary intervention
- Group 2: Naltrexone with ecological momentary intervention
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Methamphetamine Addiction Patient Testimony for trial: Trial Name: NCT04791969 — Phase 2
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