~0 spots leftby Apr 2025

Endotoxin for Alcohol Consumption Behavior

Recruiting in Palo Alto (17 mi)
Overseen byTerril Verplaetse, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Yale University
Prior Safety Data

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.

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.
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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.
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Treatment Details

Interventions

  • Endotoxin (Endotoxin)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EndotoxinExperimental Treatment1 Intervention
Endotoxin (0.4ng/kg i.v.) will be administered one time during the laboratory session.
Group II: PlaceboPlacebo Group1 Intervention
Administered one time during the laboratory session.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Yale School of MedicineNew Haven, CT
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Who Is Running the Clinical Trial?

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

References