Back to resultsInflammation in Methamphetamine and STIs (IMSTI) (IMSTI)
Primary Purpose
Methamphetamine-dependence, Rectal Gonorrhea, Rectal Chlamydia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management
Sponsored by
About this trial
This is an interventional prevention trial for Methamphetamine-dependence
Eligibility Criteria
Inclusion Criteria:
- Cisgender male
- 18 to 45 years of age
- HIV-negative
- Understand written and spoken English
- condomless anal intercourse with HIV-positive or status unknown partner in past 90 days
- Meet DSM-5 criteria for methamphetamine use disorder
- Positive urine toxicology screen for MA metabolites at study entry
- Negative syphilis screen
- 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
Sites / Locations
- UCLA Vine Street ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Contingency management
Arm Description
All enrolled participants will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use.
Outcomes
Primary Outcome Measures
Methamphetamine abstinence
Proportion of visits in which there are no detectable methamphetamine metabolites in participant urine samples
Rectal inflammation
Rectal concentrations of IL-6 (pg/mL)
Secondary Outcome Measures
Full Information
NCT ID
NCT05162391
First Posted
November 30, 2021
Last Updated
March 28, 2023
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT05162391
Brief Title
Inflammation in Methamphetamine and STIs (IMSTI)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methamphetamine-dependence, Rectal Gonorrhea, Rectal Chlamydia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Contingency management
Arm Type
Other
Arm Description
All enrolled participants will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
Contingency management intervention with incentives tied to provision of urine samples with no detectable levels of methamphetamine (MA).
Primary Outcome Measure Information:
Title
Methamphetamine abstinence
Description
Proportion of visits in which there are no detectable methamphetamine metabolites in participant urine samples
Time Frame
8 weeks
Title
Rectal inflammation
Description
Rectal concentrations of IL-6 (pg/mL)
Time Frame
8 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cherie Blair, MD, PhD
Phone
323-461-3106
Email
cherieblair@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cherie Blair
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Vine Street Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90038
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cherie Blair, MD, PhD
Phone
323-461-3106
12. IPD Sharing Statement
Learn more about this trial
Inflammation in Methamphetamine and STIs (IMSTI)
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