Expression of Stress Markers During Meth Treatment (EXPRESS+)

HIV Clinical Trial

— EXPRESS+  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05558345
• Other study ID #: 20-001564
• Secondary ID: K01DA051329
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: May 2024
• Source: University of California, Los Angeles
• Contact: Michael J Li, PhD
• Phone: 3107948530
• Email: mjli[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Substance-Related Disorders

Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)

External Links

•   Landing Page for Enrollment