Effect of Endotoxin on Alcohol Consumption

NCT ID: NCT04527185

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-27
• Study Completion Date: 2024-10-31

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.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Endotoxin

Endotoxin (0.4ng/kg i.v.) will be administered one time during the laboratory session.

Group Type: EXPERIMENTAL

Endotoxin

Intervention Type: DRUG

Endotoxin 0.4ng/kg i.v.

Placebo

Administered one time during the laboratory session.

Group Type: PLACEBO_COMPARATOR

Endotoxin

Intervention Type: DRUG

Endotoxin 0.4ng/kg i.v.

Interventions

Endotoxin

Endotoxin 0.4ng/kg i.v.

Intervention Type: DRUG

Other Intervention Names

Lipopolysaccharide

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Terril Verplaetse

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Terril Verplaetse, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R03AA028361-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000028772

Identifier Type: -

Identifier Source: org_study_id