Endotoxin Exposure to Examine the Role of Inflammation in Alcohol Use (NCT07452146) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Endotoxin Exposure to Examine the Role of Inflammation in Alcohol Use
64 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range21 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Be between the ages of 21 and 65
✓. Meet current (i.e., past month) DSM-5 diagnostic criteria for moderate to severe AUD
✓. Be non-treatment seeking for AUD
✓. Report drinking at least 28 drinks per week if male (21 drinks per week if female) in the 28 days prior to consent.
✓. Must agree to one of the following methods of birth control (if female), unless she or partner are surgically sterile:
Exclusion criteria
✕. Have a current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine
✕. Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
✕. Have current moderate to severe depression as indicated by a score of ≥ 21 on the Beck Depression Inventory - II (BDI-II)
✕. Have current suicidal ideation or lifetime history of suicide attempt as reported on the Columbia-Suicide Severity Rating Scale (C-SSRS)
✕. Have a positive urine screen for drugs other than cannabis;
✕. Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R)
✕
What they're measuring
1
Acute Phase: To determine the effect of acute inflammation on mood in AUD versus controls.
Timeframe: Mood will be collected at baseline (prior to infusion) and hourly for 6 hours post-infusion.
2
Acute Phase: To determine the effect of acute inflammation on cue-reactivity in AUD versus controls.
Timeframe: The cue-reactivity paradigm is conducted at baseline and at 2 hours post-infusion during the experimental visit.
3
Acute Phase: To determine the effect of acute inflammation on biomarkers in AUD versus controls.
Timeframe: Blood samples will be collected at baseline (prior to infusion) and hourly for 6 hours post-infusion.
4
Follow-up Phase: To determine the protracted effects of acute inflammation on self-reported craving and alcohol use in AUD versus controls.
Timeframe: 7-day follow-up phase after acute infusion visit.
5
Follow-up Phase: To determine the protracted effects of acute inflammation on mood in AUD versus controls.
Timeframe: 7-day follow-up phase after acute infusion visit.