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Phase 2 N=13 Randomized Quadruple-blind Other

Effect of Endotoxin on Alcohol Consumption

Alcohol Use Disorder

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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