Clinical trial NCT04527185: Effect of Endotoxin on Alcohol Consumption
Official title: Does Endotoxin Administration Increase Alcohol Consumption in Individuals with AUD?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Alcohol Use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-08-26
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: For this protocol, the investigators plan to collect pilot data to examine the effect of endotoxin on drinking behavior in the human laboratory.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 21-65;
2. Able to read and write English;
3. Meets DSM-5 criteria for current (past 6 months) alcohol use disorder;
4. Drinking criteria: Males - Drinks \> 14 drinks per week and exceeds 4 drinks per day at least twice per week; Females -Drinks \> 7 drinks per week and exceeds 3 drinks per day at least twice per week.
5. Must meet drinking criteria during a consecutive 30-day period within the 90 days prior to baseline;
6. Laboratory sessions will be scheduled such that subjects will not have major responsibilities on the following day which might limit drinking during the self-administration session (e.g., job interview, exam).
7. Negative urine pregnancy test for women.

Exclusion Criteria:

1. Participants with any significant current medical conditions (neurological, cardiovascular \[including hypertension or hypotension: sitting BP \>160/100 or \<90/60mmHg at baseline screening\], endocrine, thyroid, renal, liver), seizures, delirium or hallucinations, or other unstable medical conditions including HIV;
2. Current DSM-5 substance use disorders, other than alcohol or nicotine;
3. A positive test result at intake appointment on urine drug screens conducted for illicit drugs, excluding cannabis;
4. Past 30 day use of psychoactive drugs including anxiolytics and antidepressants;
5. Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives \[oral, implant, injection, patch, or ring\], contraceptive sponge, double barrier \[diaphragm or condom plus spermicide\], or IUD);
6. Suicidal, homicidal or evidence of current (past 6-month) severe mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders;
7. Subjects treatment-seeking or who are currently in treatment for alcohol use;
8. Subjects with medical conditions contraindicating alcohol use (e.g., liver enzymes ≥3× normal);
9. Subjects likely to exhibit clinically significant alcohol withdrawal during the study. We will exclude subjects who a) have a history of perceptual distortions, seizures, delirium, or hallucinations upon withdrawal, or b) have a score of \> 8 on the Clinical Institute Withdrawal Assessment scale at intake appointments;
10. Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current application.
11. Subjects \>38 on the Alcohol Use Disorders Identification Test (AUDIT)
12. Subjects with resting pulse \>100 at challenge
13. Subjects with recent (past 2 weeks) acute illness or vaccination
14. Subjects with \>Grade 2 laboratory abnormalities on screening

Primary outcomes:
measure: Alcohol consumption
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Terril Verplaetse, PhD
role: PRINCIPAL_INVESTIGATOR
References: