Ecological Momentary Intervention for Methamphetamine Use Disorder

Phase-Based Estimates
1
Effectiveness
2
Safety
San Francisco Department of Public Health, San Francisco, CA
Ecological Momentary Intervention - Behavioral
Eligibility
18+
Male
Eligible conditions
Methamphetamine Use Disorder

Study Summary

This study is evaluating whether a medication may help reduce the use of methamphetamine for men who have sex with men.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Ecological Momentary Intervention will improve 1 primary outcome, 1 secondary outcome, and 1 other outcome in patients with Methamphetamine Use Disorder. Measurement will happen over the course of Every week from enrollment to the end of treatment at 12 weeks.

Week 12
Mean change in serum drug levels (PrEP) or ART suppression rates from baseline to week 12 between Intermittent Oral Naltrexone vs placebo groups.
Mean change in sexual risk behaviors from baseline to week 12 between Intermittent Oral Naltrexone vs placebo groups.
Week 12
Mean Change in meth-positive urine tests from baseline to week 12 between Intermittent Oral Naltrexone vs. placebo groups

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Placebo with ecological momentary intervention
Naltrexone with ecological momentary intervention
Placebo group

This trial requires 54 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ecological Momentary Intervention is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Naltrexone with ecological momentary interventionNaltrexone Hydrochloride, 50 mg., intermittent with ecological momentary assessment (EMA)
Placebo with ecological momentary interventionPlacebo, intermittent with ecological momentary assessment (EMA)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naltrexone
FDA approved
Ecological Momentary Intervention
2020
N/A
~40

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: every four weeks from enrollment to the end of treatment at 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly every four weeks from enrollment to the end of treatment at 12 weeks for reporting.

Closest Location

San Francisco Department of Public Health - San Francisco, CA

Eligibility Criteria

This trial is for male patients aged 18 and older. You must have received 1 prior treatment for Methamphetamine Use Disorder. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The text is interested in reducing meth use. show original
No current illness requiring prolonged medical care. show original
The trial is not likely to progress clinically for any chronic illness. show original
able and willing to provide informed consent and adhere to visit schedule
You have a current CD4 count of ≥ 200 cells/mm3, or a CD4 count of 100-199 cells/mm3 and an HIV viral load of < 200 copies/mL (if you are living with HIV). show original
A positive meth sample can be detected with sweat patch or urine testing during a screening. show original
A person whose gender identity corresponds to their sex assigned at birth. show original
People aged 18 to 70 years can tolerate and safely use naltrexone. show original
The person has had anal sex without a condom with men in the past three months, and has missed doses of Pre-Exposure Prophylaxis or antiretroviral therapy due to meth use. show original
People who said they had used meth at least once a week in the past year. show original

Patient Q&A Section

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

What causes methamphetamine use disorder?

Add answer

This paper explains the multiple causes of MUD and provides a framework outlining how the various environmental and genetic factors that define one can interact to alter the individual's propensity to use MUD.

Unverified Answer

What are the signs of methamphetamine use disorder?

Add answer

Several behavioral symptoms of MUD are potentially relevant to diagnosing methamphetamine use disorder; however, other signs and symptoms of MUD may become more apparent as MUD progresses.

Unverified Answer

What is methamphetamine use disorder?

Add answer

The diagnosis of methamphetamine use disorder is not recommended due to a high rate of comorbidity with other substance use disorders, limited diagnostic utility for methamphetamine use alone, and high prevalence of methamphetamine use throughout the population. Nevertheless, treatment for methamphetamine-only use is warranted because the diagnosis of a lifetime cannabis use disorder is associated with an 80% lifetime risk of methamphetamine use disorder.

Unverified Answer

Can methamphetamine use disorder be cured?

Add answer

Long-term remission of MUD has not been reported previously. We demonstrate that MUD is frequently associated with a chronic psychostimulant misuse, but that a relatively small number of MUD patients exhibit a form of psychostimulant dependence that can be managed by psychotherapy.

Unverified Answer

How many people get methamphetamine use disorder a year in the United States?

Add answer

The prevalence of MUD in the U.S. is 1.36 per 1000. The highest prevalence was observed among black and Hispanic persons. The lifetime prevalence of SUD was 10.0% for all race and ethnic groups in this sample.

Unverified Answer

What are common treatments for methamphetamine use disorder?

Add answer

This paper provides a compendium of the common treatments that have been studied for mUD. Although the evidence base for many of the treatments is sparse, it can offer a preliminary guide to the most promising future treatments. The treatment of severe withdrawal symptoms is extremely important, with the potential for profound improvement both in terms of clinical outcome and reduction in the associated high levels of psychiatric distress and disability. The clinical utility of long-term CBT is currently unclear. Some preliminary evidence suggests that psychological interventions can produce long-term remission, while antidepressant drugs alone may not.

Unverified Answer

Is ecological momentary intervention typically used in combination with any other treatments?

Add answer

EMIs are beneficial for drug abuse in individuals who are less motivated to quit and who have developed a more stable pattern of illicit drug abuse. No statistically significant effects of EMIs were observed in treatments combined with other treatments.

Unverified Answer

Who should consider clinical trials for methamphetamine use disorder?

Add answer

Despite their limited design, two clinical studies suggest that there may be a benefit from the use of an MUD in the treatment of MUD. Results from a recent clinical trial suggest that the presence of alcohol or drug dependence would influence the outcome of this study. We agree that a randomized double-blind, placebo-controlled study powered expressly for this purpose would be needed to definitively answer this important question.

Unverified Answer

Is ecological momentary intervention safe for people?

Add answer

EcOP is a feasible intervention for individuals with problematic substance use. The utility of EcOP was demonstrated in three studies, involving individuals with an alcohol, cocaine, cocaine use disorder, opiate, and methamphetamine addiction. EcOP can be used to address key addiction problems and reduce relapse.

Unverified Answer

Does ecological momentary intervention improve quality of life for those with methamphetamine use disorder?

Add answer

Interventions that target quality of life for MUD clients may be beneficial. Ecological momentary interventions provide a uniquely promising approach to improving quality of life in persons with MUD.

Unverified Answer

What is the latest research for methamphetamine use disorder?

Add answer

While a limited number of studies on methamphetamine use disorder (MUD) have been published, only recently have some important findings been made. As an example, the current literature suggests that some features of MUD may be more common in females, while other features may be more common among individuals of African American versus White racial backgrounds. In addition, preliminary evidence indicates that MUD may be comorbid with depression, while some newer studies report on the existence of other comorbidities (e.g., ADHD, generalized anxiety disorder, and substance use disorders). Further research, including clinical trials, are necessary to examine these associations.

Unverified Answer

What are the latest developments in ecological momentary intervention for therapeutic use?

Add answer

Ecological momentary intervention as a form of therapy appears to provide benefits for drug abuse and dependence treatment. Further research and randomized controlled trials with appropriate sample size are needed to examine the effectiveness of EcM-I specifically for the treatment of drug abuse and dependence.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Methamphetamine Use Disorder by sharing your contact details with the study coordinator.