Expression of Stress Markers During Meth Treatment (EXPRESS+) (EXPRESS+)

May 6, 2024 updated by: Michael J. Li, PhD, MPH, University of California, Los Angeles

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90038
        • Recruiting
        • UCLA Vine Street Clinic
        • Contact:
        • Principal Investigator:
          • Michael J Li, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Inflammatory and Type I IFN Gene Expression over 12 weeks
Time Frame: 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
every 4 weeks, at baseline, Week 4, Week 8, and Week 12
Change in Methamphetamine Use over 12 weeks
Time Frame: 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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in HIV Viral Suppression over 12 weeks
Time Frame: 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
Once every 4 weeks over 12 weeks (i.e., baseline, Week 4, Week 8, Week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael J Li, PhD, UCLA Department of Family Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-001564
  • K01DA051329 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

It is possible that future collaborators of the PI (e.g., other UCLA investigators) may conduct secondary analyses on the data to answer other research questions. The other investigator may submit a concept for a research question and hypothesis to be tested using the data. This would require PI approval of a concept, and co-authorship/involvement of the PI on the study.

IPD Sharing 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.

IPD Sharing Access Criteria

Submission and PI approval of a concept sheet

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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