Effect of Endotoxin on Alcohol Consumption

Alcohol Use Disorder Clinical Trial

Official title:

Does Endotoxin Administration Increase Alcohol Consumption in Individuals With AUD?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04527185
• Other study ID #: 2000028772
• Secondary ID: 1R03AA028361-01A
• Status: Recruiting
• Phase: Phase 2
• Start date: February 27, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: Terril Verplaetse, PhD
• Phone: 203-737-6496
• Email: terril.verplaetse[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• Endotoxin
Endotoxin 0.4ng/kg i.v.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol consumption	Mean mls of alcohol consumed for endotoxin and placebo groups during 120 minute alcohol self-administration session.	120 minutes