Expression of Stress Markers During Meth Treatment (EXPRESS+)

Sponsor
University of California, Los Angeles (Other)
Overall Status
Recruiting
CT.gov ID
NCT05558345
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
55
1
2
42.9
1.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Contingency Management
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
55 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Expression of Stress Markers in MSM Living With HIV Receiving Contingency Management for Methamphetamine Use Disorder
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2025
Anticipated Study Completion Date :
Mar 31, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Inflammatory and Type I IFN Gene Expression over 12 weeks [every 4 weeks, at baseline, Week 4, Week 8, and Week 12]

    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

  2. Change in Methamphetamine Use 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.]

    Change in odds of methamphetamine use -- based on qualitative urine test result -- over 12 weeks.

Secondary Outcome Measures

  1. Change in HIV Viral Suppression over 12 weeks [Once every 4 weeks over 12 weeks (i.e., baseline, Week 4, Week 8, Week 12)]

    Change in odds of viral suppression -- based on viral load cut-off of < 200 c/mL blood -- over 12 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCLA Vine Street Clinic Los Angeles California United States 90038

Sponsors and Collaborators

  • University of California, Los Angeles
  • National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Michael J Li, PhD, UCLA Department of Family Medicine

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Michael J. Li, PhD, MPH, Assistant Professor In-Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT05558345
Other Study ID Numbers:
  • 20-001564
  • K01DA051329
First Posted:
Sep 28, 2022
Last Update Posted:
Sep 28, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2022