Substance-Related DisordersEXPRESS+NCT05558345
Expression of Stress Markers During Meth Treatment (EXPRESS+)
A study testing Contingency Management in people with Substance-Related Disorders and HIV, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders, HIV
- What is being tested?
- Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 18Show fewer
- 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
Who cannot join
- 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:
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UCLA Vine Street Clinic
Los Angeles, California, 90038
Michael J Li, PhD, 310-794-8530, mjli@mednet.ucla.edu
Michael J Li, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance-Related Disorders, HIV
- Being tested
- Contingency Management
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Change in odds of viral suppression -- based on viral load cut-off of < 200 c/mL blood -- over 12 weeks
Measured: Once every 4 weeks over 12 weeks (i.e., baseline, Week 4, Week 8, Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Sep 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Michael J. Li, PhD, MPH, University of California, Los Angeles
- Investigators
- Michael J Li, PhD, Principal investigator, UCLA Department of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558345
- Sponsor's protocol ID
- 20-001564
- Other IDs
- K01DA051329
- Acronym
- EXPRESS+
- Status last verified
- May 2024
- First submitted
- 21 Sep 2022
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Stress Markers in MSM Living With HIV Receiving Contingency Management for Methamphetamine Use Disorder
- ClinicalTrials.gov ID
- NCT05558345
- Acronym / sponsor ID
- EXPRESS+ / 20-001564
- Conditions
- Substance-Related Disorders, HIV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingency Management for Methamphetamine Reduction | Experimental | Behavioral: Contingency Management8 weeks of contingency management, twice weekly visits, with escalating rewards from $10 to $40 for negative urine tests |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
- Identifies as (cis- or transgender) female
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency ManagementA 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. | Behavioural | Contingency Management for Methamphetamine Reduction |
Primary outcome
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
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.
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Li, PhD principal investigator
UCLA Department of Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management in people with Substance-Related Disorders and HIV, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael J Li, PhD (3107948530, mjli@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.