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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
age 18-70 years* (naltrexone's tolerability and safety has been demonstrated among older adults up to age 70)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every four weeks from enrollment to the end of treatment at 12 weeks
Awards & highlights

Study Summary

This trial will test the effectiveness of naltrexone, an as-needed medication, in reducing meth use among 54 MSM who use meth. The trial will last 12 weeks and will compare naltrexone to placebo.

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.Check my eligibility
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.See study design
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 below
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I've had unprotected sex or missed HIV prevention/treatment doses due to meth use in the last 3 months.
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I am between 18 and 70 years old.
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I do not have a chronic illness that will worsen during the trial.
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I do not have a chronic illness that will worsen during the trial.
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My CD4 count is above 200, or between 100-199 with a low HIV viral load.
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I am a cisgender male.
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I am a cisgender male.
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I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every week from enrollment to the end of treatment at 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and every week from enrollment to the end of treatment at 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change in meth-positive urine tests from baseline to week 12 between Intermittent Oral Naltrexone vs. placebo groups
Secondary outcome measures
Mean change in sexual risk behaviors from baseline to week 12 between Intermittent Oral Naltrexone vs placebo groups.
Other outcome measures
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
Naltrexone Hydrochloride
2021
Completed Phase 1
~330
Ecological Momentary Intervention
2020
N/A
~40

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,445 Previous Clinical Trials
2,593,922 Total Patients Enrolled
1 Trials studying Methamphetamine Addiction
8 Patients Enrolled for Methamphetamine Addiction
University of California, San FranciscoLead Sponsor
2,491 Previous Clinical Trials
11,930,526 Total Patients Enrolled
Glenn-Milo SantosLead Sponsor
2 Previous Clinical Trials
142 Total Patients Enrolled

Media Library

Naltrexone Hydrochloride (Opioid Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04791969 — Phase 2
Methamphetamine Addiction Research Study Groups: Naltrexone with ecological momentary intervention, Placebo with ecological momentary intervention
Methamphetamine Addiction Clinical Trial 2023: Naltrexone Hydrochloride Highlights & Side Effects. Trial Name: NCT04791969 — Phase 2
Naltrexone Hydrochloride (Opioid Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04791969 — Phase 2
Methamphetamine Addiction Patient Testimony for trial: Trial Name: NCT04791969 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Ecological Momentary Intervention for use in patient care?

"Due to its Phase 2 status, Ecological Momentary Intervention has been assigned a safety rating of 2 as there is reasonable evidence for the prevention of harm but no proof that it works."

Answered by AI

Is it possible to join this medical trial?

"This clinical trial seeks 54 volunteers, ranging from 18 to 70 years of age, that are using methamphetamine. Other prerequisites include a willingness to reduce meth use; the absence of any acute medical issues necessitating prolonged care or chronic illnesses which might worsen during the study; and self-reported usage at least once per week."

Answered by AI

What other investigations have employed Ecological Momentary Intervention as a tool?

"At present, 46 clinical trials related to Ecological Momentary Intervention are underway; 12 of which have advanced to Phase 3. These studies can be found in 161 different locations around the world, though a majority of them exist within New york City."

Answered by AI

Is the research protocol currently recruiting participants?

"According to the data posted on clinicaltrials.gov, this research trial is actively seeking participants. The listing was first created on December 14th 2021 and the information has since been updated as recently as September 7th 2022."

Answered by AI

What conditions are frequently managed through Ecological Momentary Intervention?

"Ecological Momentary Intervention is a viable treatment for managing weight, enhancing physical activity, and alleviating pain caused by chronic illness."

Answered by AI

Does the cutoff age for entry into this clinical investigation rest below sixty years?

"The age range for prospective study participants is eighteen to seventy years old, according to the trial's acceptance criteria."

Answered by AI

To what extent is this trial accommodating participants?

"Affirmative. This clinical trial, which was initially posted on December 14th 2021, is currently seeking participants. 54 subjects need to be recruited from 1 medical facility. The study's details were last modified on September 7th 2022 according to data hosted on clinicaltrials.gov."

Answered by AI

Who else is applying?

What state do they live in?
California
Colorado
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
San Francisco Department of Public Health
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I need help getting off meth. I’ve tried quitting on my own but for some reason I always return. I don’t want to die,please help me to save my life!
PatientReceived 2+ prior treatments
~0 spots leftby Apr 2024