Phase 2
N=13
Effect of Endotoxin on Alcohol Consumption
Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04527185 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Alcohol Consumption — 37.57; 50.08 Milliliters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Endotoxin (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alcohol Consumption |
37.57; 50.08 | — |
Summary
For this protocol, the investigators plan to collect pilot data to examine the effect of endotoxin on drinking behavior in the human laboratory.
Eligibility Criteria
Inclusion Criteria
- Age 21-65;
- Able to read and write English;
- Meets DSM-5 criteria for current (past 6 months) alcohol use disorder;
- Drinking criteria: Males - Drinks > 14 drinks per week and exceeds 4 drinks per day at least twice per week; Females -Drinks > 7 drinks per week and exceeds 3 drinks per day at least twice per week.
- Must meet drinking criteria during a consecutive 30-day period within the 90 days prior to baseline;
- Laboratory sessions will be scheduled such that subjects will not have major responsibilities on the following day which might limit drinking during the self-administration session (e.g., job interview, exam).
- Negative urine pregnancy test for women.
Exclusion Criteria
- Participants with any significant current medical conditions (neurological, cardiovascular [including hypertension or hypotension: sitting BP >160/100 or 8 on the Clinical Institute Withdrawal Assessment scale at intake appointments;
- Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current application.
- Subjects >38 on the Alcohol Use Disorders Identification Test (AUDIT)
- Subjects with resting pulse >100 at challenge
- Subjects with recent (past 2 weeks) acute illness or vaccination
- Subjects with >Grade 2 laboratory abnormalities on screening
Data sourced from ClinicalTrials.gov (NCT04527185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.