Clinical trial NCT05558345: Expression of Stress Markers During Meth Treatment (EXPRESS+)
Official title: Expression of Stress Markers in MSM Living With HIV Receiving Contingency Management for Methamphetamine Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance-Related Disorders
HIV
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-09-28
Enrollment: 55
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Inflammatory and Type I IFN Gene Expression over 12 weeks
timeFrame: every 4 weeks, at baseline, Week 4, Week 8, and Week 12
measure: Change in Methamphetamine Use over 12 weeks
timeFrame: 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 outcomes:
measure: Change in HIV Viral Suppression over 12 weeks
timeFrame: Once every 4 weeks over 12 weeks (i.e., baseline, Week 4, Week 8, Week 12)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Vine Street Clinic
state: California
Study officials:
affiliation: UCLA Department of Family Medicine
name: Michael J Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: