Inflammation in Methamphetamine and STIs (IMSTI)

N/AActive Not RecruitingNCT05162391

University of California, Los Angeles30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Methamphetamine-dependence Rectal Gonorrhea Rectal Chlamydia

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Methamphetamine abstinence

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

Time frame: 8 weeks

Rectal inflammation

Rectal concentrations of IL-6 (pg/mL)