Inflammation in Methamphetamine and STIs (IMSTI)

Methamphetamine-dependence Clinical Trial

— IMSTI  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05162391
• Other study ID #: DA054004-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: June 30, 2027

Study information

• Verified date: May 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gonorrhea
• Inflammation
• Methamphetamine-dependence

Intervention

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

Locations

Country	Name	City	State
United States	UCLA Vine Street Clinic	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Methamphetamine abstinence	Proportion of visits in which there are no detectable methamphetamine metabolites in participant urine samples	8 weeks
Primary	Rectal inflammation	Rectal concentrations of IL-6 (pg/mL)	8 weeks