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Naltrexone + Ecological Momentary Intervention for Methamphetamine Addiction
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I've had unprotected sex or missed HIV prevention/treatment doses due to meth use in the last 3 months.I am between 18 and 70 years old.My kidney function is reduced.You use methamphetamine at least once a week according to what you have told us.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.No current illness requiring prolonged medical care.I do not have a chronic illness that will worsen during the trial.You have a problem with using methamphetamine, ranging from mild to severe.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 want to decrease your use of methamphetamine.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 am a cisgender male.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.You are willing to try to stop using methamphetamine.You use methamphetamine at least once a week, as reported by yourself.
- Group 1: Naltrexone with ecological momentary intervention
- Group 2: Placebo with ecological momentary intervention
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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