Inflammation in Methamphetamine and STIs (IMSTI)

NCT05162391 | Active Not Recruiting

• 1 other identifier: DA054004-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Methamphetamine-dependence; Rectal Gonorrhea; Rectal Chlamydia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Contingency management

OTHER

All enrolled participants will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use.

Behavioral: Contingency Management

Interventions

Contingency Management BEHAVIORAL

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

Contingency management

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cisgender male
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Vine Street Clinic

Los Angeles, California, 90038, United States

Location

Study Officials

• Cherie Blair

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 17, 2021
• Study Start: May 31, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)