Trial Outcomes & Findings for Inflammation in Methamphetamine and STIs (IMSTI) (NCT NCT05162391)
NCT ID: NCT05162391
Last Updated: 2026-06-11
Results Overview
Percentage of visits in which there are no detectable methamphetamine metabolites in participant urine samples
COMPLETED
NA
59 participants
8 weeks
2026-06-11
Participant Flow
Participants who were lost to follow-up or withdrawn from the study were replaced to ensure sufficient power in analyses.
Participant milestones
| Measure |
Contingency Management
All enrolled participants will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use.
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inflammation in Methamphetamine and STIs (IMSTI)
Baseline characteristics by cohort
| Measure |
Contingency Management
n=30 Participants
All enrolled participants will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
|
STI at baseline
|
7 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: 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.
Percentage of visits in which there are no detectable methamphetamine metabolites in participant urine samples
Outcome measures
| Measure |
Contingency Management
n=213 Visits
All enrolled participants will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use.
|
|---|---|
|
Methamphetamine Abstinence
|
41 Visits
|
PRIMARY outcome
Timeframe: 8 weeksRectal concentrations of IL-6 (pg/mL)
Outcome measures
| Measure |
Contingency Management
n=30 Participants
All enrolled participants will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use.
|
|---|---|
|
Rectal Inflammation
|
1.27 pg/ml
Interval 0.07 to 3462.39
|
Adverse Events
Contingency Management
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place