Endotoxin Exposure to Examine the Role of Inflammation in Alcohol Use

Sponsor
University of California, Los Angeles
Study ID
NCT07452146
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Endotoxin — DRUG
    Bolus dose of 0.8 ng/kg
  • Placebo saline — OTHER
    Matched to endotoxin

Study Details

The study design consists of a randomized, double-blind, placebo-controlled study of low dose endotoxin. Individuals with current AUD (n=32) and matched controls without AUD (n=32) will be randomly assigned to receive a single intravenous (I.V.) infusion of either low dose endotoxin (0.8 ng/kg of body weight) or placebo (same volume of 0.9% saline solution) to determine the acute and protracted role of inflammation in alcohol use.

Key Dates

First listed
Mar 5, 2026
Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Endotoxin
    Individuals with alcohol use disorder vs. control who receive a bolus dose of endotoxin (0.8 ng/kg of body weight).
  • Placebo Comparator: Placebo
    Individuals with alcohol use disorder vs. control matched to endotoxin at same volume of 0.9% saline solution.

Primary Outcome Measure

Acute Phase: To determine the effect of acute inflammation on mood in AUD versus controls. [ Time Frame: Mood will be collected at baseline (prior to infusion) and hourly for 6 hours post-infusion. ]

Central Contacts

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