Inflammation in Methamphetamine and STIs (IMSTI)

NCT ID: NCT05162391

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2027-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Contingency management

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

Group Type: OTHER

Contingency Management

Intervention Type: BEHAVIORAL

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

Interventions

Contingency Management

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Cherie Blair, MD, PhD

Assistant Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cherie Blair

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Vine Street Clinic

Los Angeles, California, United States

Countries

United States

Other Identifiers

DA054004-01A1

Identifier Type: -

Identifier Source: org_study_id