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
This trial accepts healthy volunteersQualifiers
Be between the ages of 21 and 65
Meet current (i.e., past month) DSM-5 diagnostic criteria for moderate to severe AUD
Alcohol use disorder identification test (AUDIT) score <20
Be non-treatment seeking for AUD
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, major depressive 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 onvthe Columbia-Suicide Severity Rating Scale (C-SSRS)
Trial design
Design model
Parallel
Treatments tested in this trial
Endotoxin
DrugBolus dose of 0.8 ng/kg
Placebo saline
Other interventionMatched to endotoxin
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: EndotoxinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Acute Phase: To determine the effect of acute inflammation on mood in AUD versus controls.
The Profile of Mood States (POMS) is a self-report questionnaire that measures dimensions of mood. Four items from the POMS were summed to calculate the negative mood subscale. The items included "discouraged," downhearted," "uneasy," and "anxious." Participants rated the extent that they felt items "right now" on a scale from 0-4, with higher scores indicating more endorsement of the items. Items were summed to calculate negative mood subscale with the score ranging from 0-16, with higher scores indicating higher negative mood. The investigators were interested in whether low dose endotoxin would increase negative mood as compared to placebo in AUD vs control.
Time frame
Mood will be collected at baseline (prior to infusion) and hourly for 4 hours post-infusion.2
Acute Phase: To determine the effect of acute inflammation on cue-reactivity in AUD versus controls.
Alcohol Urge Questionnaire (AUQ) score is the primary outcome for the cue-reactivity paradigm. The AUQ is comprised of eight items rated on a 7-point Likert scale with items related to the subjective experience of alcohol craving. The minimum value is 8 and the maximum value is 56 with a higher score indicating greater subjective alcohol craving. Phasic craving for alcohol following alcohol cue exposure was assessed using the first and last items from the AUQ during an alcohol cue reactivity paradigm at baseline and at time of expected peak cytokine response (T2). This subscale of 2 items about desire to drink rated on a 7-point Likert scale provided a minimum possible value of 2 and a maximum value of 14, with higher values indicating a higher craving to drink alcohol. The investigators are primarily interested in whether low dose endotoxin increases cue-induced craving for alcohol relative to placebo in AUD vs control.
Time frame
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.
Plasma levels of inflammatory cytokines Interleukin-6 (IL-6), IL-8, and tumor necrosis factor-α (TNF- α) will be collected at baseline and hourly timepoints post-infusion for 6 hours. The investigators are primarily interested in whether low dose endotoxin increases peripheral cytokines relative to placebo in AUD vs control.
Time frame
Blood samples will be collected at baseline (prior to infusion) and hourly for 4 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.
Individuals will complete a 14-day follow-up after the infusion visit consisting of daily diary online questionnaires to assess protracted endotoxin-induced effects on alcohol craving (Alcohol Urge Questionnaire (AUQ)) and alcohol consumption.
Time frame
14-day follow-up phase after acute infusion visit.Locations
Sponsors and contacts
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University of California, Los Angeles
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov
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