Methamphetamine-dependence, Rectal Chlamydia, Rectal Gonorrhea
Conditions
Brief summary
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.
Interventions
BEHAVIORALContingency Management
Contingency management intervention with incentives tied to provision of urine samples with no detectable levels of methamphetamine (MA).
Sponsors
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Cisgender male * 18 years of age or older * Understand written and spoken English * Condomless receptive anal intercourse in past 90 days * Meet DSM-5 criteria for methamphetamine use disorder * Positive urine toxicology screen for MA metabolites at study entry * Negative rectal GC/CT screen (n=20) or Positive rectal GC and/or CT screen (n=20) * Able to provide written informed consent and willing/able to complete study visits.
Exclusion criteria
* Reports current treatment for another substance use disorder * Positive test for opioids, cocaine, and/or hallucinogens * Treatment for gonorrhea and/or chlamydia infection in past 3 months * Presence of a condition that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Methamphetamine Abstinence | 8 weeks | Percentage of visits in which there are no detectable methamphetamine metabolites in participant urine samples |
| Rectal Inflammation | 8 weeks | Rectal concentrations of IL-6 (pg/mL) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCherie Blair
University of California, Los Angeles
Participant flow
Pre-assignment details
Participants who were lost to follow-up or withdrawn from the study were replaced to ensure sufficient power in analyses.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 30 Participants |
| STI at baseline | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
None listed