ClinicalTrials.Veeva

Menu

Expression of Stress Markers During Meth Treatment (EXPRESS+)

University of California, Los Angeles (UCLA) logo

University of California, Los Angeles (UCLA)

Status

Enrolling

Conditions

HIV
Substance-Related Disorders

Treatments

Behavioral: Contingency Management

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05558345
20-001564
K01DA051329 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 estimated patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

55 participants in 2 patient groups

Contingency Management for Methamphetamine Reduction
Experimental group
Description:
8 weeks of contingency management, twice weekly visits, with escalating rewards from $10 to $40 for negative urine tests
Treatment:
Behavioral: Contingency Management
Non-substance-using Control
No Intervention group
Description:
Observational visits (no intervention) at baseline, Week 4, Week 8, and Week 12 for those who do not use methamphetamine.

Trial documents
1

Trial contacts and locations

1

Loading...

Central trial contact

Michael J Li, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems