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CompletedNCT05162391IMSTIUpdated Jun 11, 2026Results posted

Inflammation in Methamphetamine and STIs (IMSTI)

An interventional study of Contingency Management in Methamphetamine-dependence, Rectal Gonorrhea and Rectal Chlamydia, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
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Study 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.

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Conditions studied

  • Methamphetamine-dependence
  • Rectal Gonorrhea
  • Rectal Chlamydia
03

In context

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Other
    Contingency management

    All enrolled participants will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use.

    Behavioral: Contingency Management

Interventions

  • BehavioralContingency Management

    Contingency management intervention with incentives tied to provision of urine samples with no detectable levels of methamphetamine (MA).

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What researchers measure

Primary outcomes

  1. Methamphetamine Abstinence

    Percentage of visits in which there are no detectable methamphetamine metabolites in participant urine samples

    Time frame: 8 weeks

  2. Rectal Inflammation

    Rectal concentrations of IL-6 (pg/mL)

    Time frame: 8 weeks

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Results

Posted Jun 11, 2026

Participant flow

Participant flow — Overall Study
MilestoneContingency Management
Started59
Completed30
Not completed29

Outcome measures

PrimaryMethamphetamine Abstinence

Percentage of visits in which there are no detectable methamphetamine metabolites in participant urine samples

Time frame:
8 weeks
Reported as:
Count of units · Visits
Methamphetamine Abstinence
VisitsContingency Management
Methamphetamine Abstinence41
PrimaryRectal Inflammation

Rectal concentrations of IL-6 (pg/mL)

Time frame:
8 weeks
Reported as:
Median · pg/ml
Rectal Inflammation
pg/mlContingency Management
Rectal Inflammation1.27 (0.07 to 3462.39)

Adverse events

Collected over From enrollment until end of follow-up, up to 8 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Contingency Management0/30 (0%)0/30 (0%)0/30 (0%)

Baseline characteristics

Participants who were lost to follow-up were not included in analyses

Age, Categorical
Age, Categorical(Participants)Contingency Management
<=18 years0
Between 18 and 65 years30
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Contingency Management
Female0
Male30
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Contingency Management
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American10
White8
More than one race8
Unknown or Not Reported4
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Contingency Management
Hispanic or Latino13
Not Hispanic or Latino15
Unknown or Not Reported2
STI at baseline
STI at baseline(Participants)Contingency Management
Count of participants7
08

Study locations

1 site
  • UCLA Vine Street Clinic
    Los Angeles, California 90038, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 7, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05162391
Lead sponsor
University of California, Los Angeles
Responsible party
Cherie Blair, MD, PhD (Assistant Clinical Professor, University of California, Los Angeles) — Principal investigator
First posted
Dec 17, 2021
Start date
May 31, 2022
Primary completion
Apr 15, 2026
Completion
Apr 15, 2026
Results posted
Jun 11, 2026
Last update
Jun 11, 2026

Study contacts

Cherie Blair
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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