For this protocol, the investigators plan to collect pilot data to examine the effect of endotoxin on drinking behavior in the human laboratory.
This pilot study is a double-blind, placebo-controlled design, which will compare endotoxin (0.4ng/kg i.v.) to placebo (0.0ng/kg) in non-treatment seeking adults meeting criteria for DSM-5 alcohol use disorders (n=32 total, n=16 per group). Eligibility screening consists of an intake session and a physical exam. Participants meeting eligibility criteria will be randomized to receive a single dose of 0.4ng/kg i.v. endotoxin or placebo during a single laboratory session to evaluate ad-libitum alcohol consumption. During the laboratory session, endotoxin (or placebo) administration will precede a 2-hour alcohol self-administration period. Participants will be scheduled for a follow-up appointment to evaluate drinking behavior. Adverse events are evaluated during the laboratory session and follow-up, and will be tabulated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
27
Endotoxin 0.4ng/kg i.v.
Yale School of Medicine
New Haven, Connecticut, United States
Alcohol Consumption
Mean mls of alcohol consumed for endotoxin and placebo groups during 120 minute alcohol self-administration session.
Time frame: 120 minutes
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