Endotoxin Exposure to Examine the Role of Inflammation in Alcohol Use
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-65
SponsorUniversity of California, Los Angeles
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Endotoxin
- Placebo saline
Treatment groups
64 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
University of California, Los Angeles
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov