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

Primary Purpose

Substance-Related Disorders, HIV

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts 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

Sites / Locations

  • UCLA Vine Street ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Contingency Management for Methamphetamine Reduction

Non-substance-using Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
Change in Methamphetamine Use over 12 weeks
Change in odds of methamphetamine use -- based on qualitative urine test result -- over 12 weeks.

Secondary Outcome Measures

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

Full Information

First Posted
September 21, 2022
Last Updated
September 23, 2022
Sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05558345
Brief Title
Expression of Stress Markers During Meth Treatment (EXPRESS+)
Acronym
EXPRESS+
Official Title
Expression of Stress Markers in MSM Living With HIV Receiving Contingency Management for Methamphetamine Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders, HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Contingency Management for Methamphetamine Reduction
Arm Type
Experimental
Arm Description
8 weeks of contingency management, twice weekly visits, with escalating rewards from $10 to $40 for negative urine tests
Arm Title
Non-substance-using Control
Arm Type
No Intervention
Arm Description
Observational visits (no intervention) at baseline, Week 4, Week 8, and Week 12 for those who do not use methamphetamine.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Inflammatory and Type I IFN Gene Expression over 12 weeks
Description
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
Time Frame
every 4 weeks, at baseline, Week 4, Week 8, and Week 12
Title
Change in Methamphetamine Use over 12 weeks
Description
Change in odds of methamphetamine use -- based on qualitative urine test result -- 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.
Secondary Outcome Measure Information:
Title
Change in HIV Viral Suppression over 12 weeks
Description
Change in odds of viral suppression -- based on viral load cut-off of < 200 c/mL blood -- over 12 weeks
Time Frame
Once every 4 weeks over 12 weeks (i.e., baseline, Week 4, Week 8, Week 12)

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Assigned male sex at birth but does not identify as female.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For Contingency Management: Assigned male sex at birth 18 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 18 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael J Li, PhD
Phone
3107948530
Email
mjli@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Li, PhD
Organizational Affiliation
UCLA Department of Family Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Vine Street Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90038
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael J Li, PhD
Phone
310-794-8530
Email
mjli@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Michael J Li, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Links:
URL
https://vinestreet.uclacbam.org/study/express+
Description
Landing Page for Enrollment

Learn more about this trial

Expression of Stress Markers During Meth Treatment (EXPRESS+)

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