Inflammation in Methamphetamine and STIs (IMSTI) (NCT05162391) | Clinical Trial Compass
CompletedNot Applicable
Inflammation in Methamphetamine and STIs (IMSTI)
United States59 participantsStarted 2022-05-31
Plain-language summary
This clinical trial aims to investigate the effects of a decline in methamphetamine use on rectal inflammatory cytokine levels, substance use contexts, and HIV/STI risk behavior. This clinical trial also seeks to evaluate joint effects of methamphetamine use and rectal gonorrhea/chlamydia infection on rectal inflammatory cytokine levels. The proposed trial will consist of 40 MSM, half with rectal gonorrhea/chlamydia infection at enrollment (n=20), with methamphetamine use disorder that will receive contingency management for methamphetamine reduction. Following baseline measurement, participants will be observed over the course of 8 weeks, where participants will complete behavioral surveys, provide urine for drug testing, and rectal samples for measurement of rectal inflammatory cytokine levels.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Cisgender male
* 18 years of age or older
* Understand written and spoken English
* Condomless receptive anal intercourse in past 90 days
* Meet DSM-5 criteria for methamphetamine use disorder
* Positive urine toxicology screen for MA metabolites at study entry
* Negative rectal GC/CT screen (n=20) or Positive rectal GC and/or CT screen (n=20)
* Able to provide written informed consent and willing/able to complete study visits.
Exclusion Criteria:
* Reports current treatment for another substance use disorder
* Positive test for opioids, cocaine, and/or hallucinogens
* Treatment for gonorrhea and/or chlamydia infection in past 3 months
* Presence of a condition that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.