Inflammation in Methamphetamine and STIs (IMSTI) (IMSTI)

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

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 Overview

• Status: Recruiting
• Conditions: Methamphetamine-dependence; Rectal Gonorrhea; Rectal Chlamydia
• Intervention / Treatment: Behavioral: Contingency Management

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cherie Blair, MD, PhD; Phone Number: 323-461-3106; Email: cherieblair@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90038
      • Recruiting
      • UCLA Vine Street Clinic
      • Contact: Cherie Blair, MD, PhD; Phone Number: 323-461-3106

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Contingency management; All enrolled participants will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use.	Behavioral: Contingency Management; Contingency management intervention with incentives tied to provision of urine samples with no detectable levels of methamphetamine (MA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Cherie Blair, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Anticipated): June 30, 2026
• Study Completion (Anticipated): June 30, 2027

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Sexually Transmitted Diseases, Bacterial; Inflammation; Gonorrhea
• Other Study ID Numbers: DA054004-01A1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No