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Completed

NCT Number: NCT05162391

Inflammation in Methamphetamine and STIs (IMSTI)

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.

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Key information

Conditions

Methamphetamine-dependence Rectal Chlamydia Rectal Gonorrhea

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Vine Street Clinic

Los Angeles, California, 90038, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contingency Management

Behavioral

Contingency management intervention with incentives tied to provision of urine samples with no detectable levels of methamphetamine (MA).

Primary outcomes

  1. Methamphetamine Abstinence

    Time frame: 8 weeks

    Percentage of visits in which there are no detectable methamphetamine metabolites in participant urine samples

  2. Rectal Inflammation

    Time frame: 8 weeks

    Rectal concentrations of IL-6 (pg/mL)

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Acronym: IMSTI

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2021
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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