Inflammation in Methamphetamine and STIs (IMSTI)

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Methamphetamine Use on Risk Behavior, Systemic and Mucosal Inflammation, and Sexually Transmitted Infection (STI)/HIV Risk Among Men Who Have Sex With Men

Conditions
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Methamphetamine-dependence, Rectal Gonorrhea, Rectal Chlamydia

Intervention / Treatment
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* Behavioral: Contingency Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Contingency management<br>All enrolled participants will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use. | Behavioral: Contingency Management<br>* Contingency management intervention with incentives tied to provision of urine samples with no detectable levels of methamphetamine (MA).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methamphetamine abstinence | Proportion of visits in which there are no detectable methamphetamine metabolites in participant urine samples | 8 weeks | 
| Rectal inflammation | Rectal concentrations of IL-6 (pg/mL) | 8 weeks |