Trial Outcomes & Findings for Effect of Endotoxin on Alcohol Consumption (NCT NCT04527185)
NCT ID: NCT04527185
Last Updated: 2025-11-03
Results Overview
Mean mls of alcohol consumed for endotoxin and placebo groups during 120 minute alcohol self-administration session.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
120 minutes
Results posted on
2025-11-03
Participant Flow
Participants randomly assigned to endotoxin or placebo prior to the lab session.
Participant milestones
| Measure |
Endotoxin
Endotoxin (0.4ng/kg i.v.) will be administered one time during the laboratory session.
|
Placebo
Administered one time during the laboratory session.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Endotoxin on Alcohol Consumption
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Administered one time during the laboratory session.
|
Total
n=13 Participants
Total of all reporting groups
|
Endotoxin
n=7 Participants
Endotoxin (0.4ng/kg i.v.) will be administered one time during the laboratory session.
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
2 Participants
n=18 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=15 Participants
|
5 Participants
n=18 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=15 Participants
|
5 Participants
n=18 Participants
|
3 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=15 Participants
|
13 participants
n=18 Participants
|
7 participants
n=3 Participants
|
|
Marital Status
Married
|
0 Participants
n=15 Participants
|
2 Participants
n=18 Participants
|
2 Participants
n=3 Participants
|
|
Marital Status
Divorced
|
1 Participants
n=15 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=3 Participants
|
|
Marital Status
Single
|
4 Participants
n=15 Participants
|
9 Participants
n=18 Participants
|
5 Participants
n=3 Participants
|
|
Marital Status
Cohabitating
|
1 Participants
n=15 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=15 Participants
|
13 Participants
n=18 Participants
|
7 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=15 Participants
|
5 Participants
n=18 Participants
|
3 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=15 Participants
|
8 Participants
n=18 Participants
|
4 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=15 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 120 minutesMean mls of alcohol consumed for endotoxin and placebo groups during 120 minute alcohol self-administration session.
Outcome measures
| Measure |
Endotoxin
n=7 Participants
Endotoxin (0.4ng/kg i.v.) will be administered one time during the laboratory session.
|
Placebo
n=6 Participants
Administered one time during the laboratory session.
|
|---|---|---|
|
Alcohol Consumption
|
37.57 Milliliters
Standard Deviation 47.27
|
50.08 Milliliters
Standard Deviation 37.58
|
Adverse Events
Endotoxin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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