Expression of Stress Markers During Meth Treatment (EXPRESS+) (EXPRESS+)

Expression of Stress Markers in MSM Living With HIV Receiving Contingency Management for Methamphetamine Use Disorder

This is a non-randomized behavioral trial that aims to investigate whether changes in inflammatory and type I IFN expression coincide with changes in methamphetamine use and viral load over the course of 12 weeks in HIV-positive people assigned male at birth with and without methamphetamine use disorder.

Study Overview

• Status: Recruiting
• Conditions: Substance-Related Disorders; HIV
• Intervention / Treatment: Behavioral: Contingency Management

Detailed Description

This is a within-subjects, two-arm study with 35 HIV-positive people assigned male at birth receiving contingency management for treatment of methamphetamine use disorder and 20 HIV-positive people assigned male at birth serving as a non-substance-using healthy control (N=55 total). HIV-positive participants with methamphetamine use disorder who meet the eligibility criteria will be assigned to the contingency management treatment group. HIV-positive participants who do not use substances and meet the specific criteria will be assigned to the non-substance-using control group. Participants will be observed over 8 weeks, with another follow-up 4 weeks thereafter.

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael J Li, PhD; Phone Number: 3107948530; Email: mjli@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90038
      • Recruiting
      • UCLA Vine Street Clinic
      • Contact: Michael J Li, PhD; Phone Number: 310-794-8530; Email: mjli@mednet.ucla.edu
      • Principal Investigator: Michael J Li, PhD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

For Contingency Management:

1. Assigned male sex at birth
2. 18 to 45 years of age
3. Reports having sex with men in the past 12 months.
4. HIV-positive (confirmed by certification or by HIV rapid test)
5. Has an HIV care provider (last seen in the past 12 months)
6. Has a current antiretroviral prescription
7. Meets the DSM-5 criteria for methamphetamine use disorder using SCID-5
8. Urine test is positive for methamphetamine within 30 days of their screening visit
9. Seeking treatment for methamphetamine use disorder.
10. Ability to attend twice weekly appointments for drug testing and treatment

For Non-substance-using Control:

1. Assigned male sex at birth
2. 18 to 45 years of age
3. Reports having sex with men in the past 12 months.
4. HIV-positive (confirmed by certification or by HIV rapid test)
5. Has an HIV care provider (last seen in the past 12 months)
6. Has a current antiretroviral prescription

Exclusion Criteria:

For Contingency Management:

1. Identifies as (cis- or transgender) female
2. Reports another current or past substance use disorder
3. Reports being in another intervention or clinical trial for substance use
4. Positive test for opioids, cocaine, and/or MDMA

For Non-substance-using Control:

1. Identifies as (cis- or transgender) female
2. Positive test for methamphetamine, opioids, cocaine, and/or MDMA.
3. Reports substance use (methamphetamine, opioids, cocaine, MDMA, hallucinogens, heavy alcohol use, and/or tobacco) in the past 6 months
4. Reports past or current substance use disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contingency Management for Methamphetamine Reduction; 8 weeks of contingency management, twice weekly visits, with escalating rewards from $10 to $40 for negative urine tests	Behavioral: Contingency Management; A positive reinforcement behavioral treatment with escalating rewards for consecutive negative urine tests, starting at $10 and capped at a maximum of $40 per negative result.
No Intervention: Non-substance-using Control; Observational visits (no intervention) at baseline, Week 4, Week 8, and Week 12 for those who do not use methamphetamine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Inflammatory and Type I IFN Gene Expression over 12 weeks	Change in gene expression values -- based on count per million or reference gene normalized mRNA extracted from leukocytes and mapped to 53 a priori specified genes -- averaged over 4 times points using mixed linear regression	every 4 weeks, at baseline, Week 4, Week 8, and Week 12
Change in Methamphetamine Use over 12 weeks	Change in odds of methamphetamine use -- based on qualitative urine test result -- over 12 weeks.	twice weekly for 8 weeks with 4-week follow-up in the contingency management group; once every 4 weeks over 12 weeks for the control group.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HIV Viral Suppression over 12 weeks	Change in odds of viral suppression -- based on viral load cut-off of < 200 c/mL blood -- over 12 weeks	Once every 4 weeks over 12 weeks (i.e., baseline, Week 4, Week 8, Week 12)

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Michael J Li, PhD, UCLA Department of Family Medicine

Publications and helpful links

Helpful Links

• Landing Page for Enrollment

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 20-001564; K01DA051329 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It is possible that future collaborators of the PI (e.g., other UCLA investigators) may conduct secondary analyses on the data to answer other research questions. The other investigator may submit a concept for a research question and hypothesis to be tested using the data. This would require PI approval of a concept, and co-authorship/involvement of the PI on the study.
• IPD Sharing Time Frame: After the PI completes publication of their specific aims and any secondary outcomes, data will be available for at least 3 years thereafter.
• IPD Sharing Access Criteria: Submission and PI approval of a concept sheet
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No