Inflammation in Methamphetamine and STIs (IMSTI)

Not Applicable

Active, not recruiting

• Conditions: Methamphetamine-dependence; Rectal Gonorrhea; Rectal Chlamydia

• Registration Number: NCT05162391
• Lead Sponsor: University of California, Los Angeles

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2021-12-17
• Study Start: 2022-05-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

UCLA Vine Street Clinic; 🇺🇸 Los Angeles, California, United States