What side effects are associated with this type of intervention?

Naltrexone, an opioid receptor antagonist, is commonly used in the treatment of methamphetamine addiction. Known side effects of naltrexone include nausea, headache, dizziness, fatigue, insomnia, and anxiety. In some cases, it can also cause liver toxicity, so liver function should be monitored during treatment. Other treatments for methamphetamine addiction, such as behavioral therapies, do not have pharmacologic side effects but may require significant patient commitment and support.

What prior FDA approvals exist?

The provided context does not mention any specific FDA approvals for the treatment of methamphetamine addiction using naltrexone or similar opioid receptor antagonists. However, it does reference a trial studying the use of intermittent oral naltrexone enhanced with an Ecological Momentary Intervention (EMI) platform for methamphetamine-using MSM. This suggests ongoing research into the efficacy of naltrexone for this purpose, but no definitive FDA approval is noted in the context.

What other types of research exist?

Promising novel alternatives to Naltrexone for Methamphetamine Addiction include Prasugrel and Ticagrelor, which are being studied for their potential to reduce vaso-occlusive events and crises. Additionally, cognitive-behavioral therapy (CBT) combined with buprenorphine has shown efficacy in opioid use disorder and may be adapted for methamphetamine addiction. Another potential alternative is the use of selective dopamine and norepinephrine reuptake inhibitors like Solriamfetol, which has wake-promoting effects and may help manage addiction-related fatigue and sleep disturbances.

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Opioid Antagonist

Naltrexone + Ecological Momentary Intervention for Methamphetamine Addiction

Q: What is the mechanism of action of this treatment?

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.

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 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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced.

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

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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

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

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

0 / 6Eligibility criteria met

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.