Endotoxin for Alcohol Consumption Behavior

Overseen By Terril L Verplaetse, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must not be taking: Anxiolytics, Antidepressants

Disqualifiers: Hypertension, Seizures, Schizophrenia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

32 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Terril Verplaetse, PhD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for adults aged 21-65 who can read and write English, meet the criteria for current alcohol use disorder, and have a specific pattern of drinking. Pregnant or nursing women, those on certain medications or with medical conditions that make alcohol dangerous are excluded.

Inclusion Criteria

I drink more than the specified weekly limit for my gender.

You have been diagnosed with a drinking problem in the past 6 months according to the DSM-5 guidelines.

I am between 21 and 65 years old.

Exclusion Criteria

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.

Current DSM-5 substance use disorders, other than alcohol or nicotine

I am not pregnant or nursing and use effective birth control or am surgically sterile/postmenopausal.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive a single dose of endotoxin or placebo during a laboratory session

1 day

1 visit (in-person)

Follow-up

Participants are monitored for drinking behavior and adverse events after the laboratory session

1 week

1 visit (in-person)

Treatment Details

Interventions

• Endotoxin

Trial Overview The study is investigating how endotoxin affects drinking behavior in people with alcohol use disorder. Participants will be observed in a controlled environment to see if endotoxin influences their alcohol consumption.

Participant Groups

Group I: Endotoxin Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

Administered one time during the laboratory session.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+