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This clinical trial aims to investigate the effects of a decline in methamphetamine use on rectal inflammatory cytokine levels, substance use contexts, and HIV/STI risk behavior. This clinical trial also seeks to evaluate joint effects of methamphetamine use and rectal gonorrhea/chlamydia infection on rectal inflammatory cytokine levels. The proposed trial will consist of 40 MSM, half with rectal gonorrhea/chlamydia infection at enrollment (n=20), with methamphetamine use disorder that will receive contingency management for methamphetamine reduction. Following baseline measurement, participants will be observed over the course of 8 weeks, where participants will complete behavioral surveys, provide urine for drug testing, and rectal samples for measurement of rectal inflammatory cytokine levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contingency management | Other | All enrolled participants will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contingency Management | Behavioral | Contingency management intervention with incentives tied to provision of urine samples with no detectable levels of methamphetamine (MA). |
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| Measure | Description | Time Frame |
|---|---|---|
| Methamphetamine Abstinence | Percentage of visits in which there are no detectable methamphetamine metabolites in participant urine samples | 8 weeks |
| Rectal Inflammation | Rectal concentrations of IL-6 (pg/mL) | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cherie Blair | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Vine Street Clinic | Los Angeles | California | 90038 | United States |
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Participants who were lost to follow-up or withdrawn from the study were replaced to ensure sufficient power in analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Contingency Management | All enrolled participants will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who were lost to follow-up were not included in analyses
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| ID | Title | Description |
|---|---|---|
| BG000 | Contingency Management | All enrolled participants will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Methamphetamine Abstinence | Percentage of visits in which there are no detectable methamphetamine metabolites in participant urine samples | All 30 participants included in the analysis were evaluated for the primary outcome. Data is evaluated by total number of study visits completed (n=213). Of the 213 study visits total, 41 visits had no detectable methamphetamine metabolites in participant urine samples. | Posted | Count of Units | Visits | 8 weeks | Visits | Visits |
|
From enrollment until end of follow-up, up to 8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Contingency Management | All enrolled participants will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cherie Blair | David Geffen School of Medicine at UCLA | 3108253807 | cherieblair@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2023 | May 14, 2026 | Prot_SAP_000.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| STI at baseline | Count of Participants | Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
| Visits |
|
|
| Primary | Rectal Inflammation | Rectal concentrations of IL-6 (pg/mL) | Posted | Median | Full Range | pg/ml | 8 weeks |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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