Expression of Stress Markers During Meth Treatment (EXPRESS+)

NCT05558345 | Recruiting

• 2 other identifiers: 20-001564K01DA051329
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance-Related Disorders; HIV

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (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)

Study Arms (2)

Contingency Management for Methamphetamine Reduction

EXPERIMENTAL

8 weeks of contingency management, twice weekly visits, with escalating rewards from $10 to $40 for negative urine tests

Behavioral: Contingency Management

Non-substance-using Control

NO INTERVENTION

Observational visits (no intervention) at baseline, Week 4, Week 8, and Week 12 for those who do not use methamphetamine.

Interventions

Contingency Management BEHAVIORAL

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.

Contingency Management for Methamphetamine Reduction

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Assigned male sex at birth but does not identify as female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For Contingency Management:
• Assigned male sex at birth
• to 45 years of age
• Reports having sex with men in the past 12 months.
• HIV-positive (confirmed by certification or by HIV rapid test)
• Has an HIV care provider (last seen in the past 12 months)
• Has a current antiretroviral prescription
• Meets the DSM-5 criteria for methamphetamine use disorder using SCID-5
• Urine test is positive for methamphetamine within 30 days of their screening visit
• Seeking treatment for methamphetamine use disorder.
• Ability to attend twice weekly appointments for drug testing and treatment
• For Non-substance-using Control:
• Assigned male sex at birth
• to 45 years of age
• Reports having sex with men in the past 12 months.

You may not qualify if:

• For Contingency Management:
• Identifies as (cis- or transgender) female
• Reports another current or past substance use disorder
• Reports being in another intervention or clinical trial for substance use
• Positive test for opioids, cocaine, and/or MDMA
• For Non-substance-using Control:
• Identifies as (cis- or transgender) female
• Positive test for methamphetamine, opioids, cocaine, and/or MDMA.
• Reports substance use (methamphetamine, opioids, cocaine, MDMA, hallucinogens, heavy alcohol use, and/or tobacco) in the past 6 months
• Reports past or current substance use disorder

Sponsors & Collaborators

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

Study Sites (1)

UCLA Vine Street Clinic

Los Angeles, California, 90038, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michael J Li, PhD

  UCLA Department of Family Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael J Li, PhD

CONTACT

3107948530; mjli@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor In-Residence

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 28, 2022
• Study Start: September 1, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2026
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: Submission and PI approval of a concept sheet

Locations

US (1)