Effect of Endotoxin on Alcohol Consumption

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04527185
Study type	Interventional
Source	Yale University
Contact	Terril Verplaetse, PhD
Phone	203-737-6496
Email	terril.verplaetse@yale.edu
Status	Recruiting
Phase	Phase 2
Start date	February 27, 2022
Completion date	October 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04788004` - Long-term Recovery: Longitudinal Study of Neuro-behavioral Markers of Recovery and Precipitants of Relapse
Recruiting	`NCT05684094` - Mechanisms of Risky Alcohol Use in Young Adults: Linking Sleep to Reward- and Stress-Related Brain Function	N/A
Completed	`NCT03406039` - Testing the Efficacy of an Online Integrated Treatment for Comorbid Alcohol Misuse and Emotional Problems	N/A
Completed	`NCT03573167` - Mobile Phone-Based Motivational Interviewing in Kenya	N/A
Completed	`NCT04817410` - ED Initiated Oral Naltrexone for AUD	Phase 1
Active, not recruiting	`NCT04267692` - Harm Reduction Talking Circles for American Indians and Alaska Natives With Alcohol Use Disorders	N/A
Completed	`NCT03872128` - The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders	Phase 1
Completed	`NCT02989662` - INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers	Phase 1/Phase 2
Recruiting	`NCT06030154` - Amplification of Positivity for Alcohol Use	N/A
Active, not recruiting	`NCT05419128` - Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19	N/A
Completed	`NCT04564807` - Testing an Online Insomnia Intervention	N/A
Completed	`NCT04284813` - Families With Substance Use and Psychosis: A Pilot Study	N/A
Completed	`NCT04203966` - Mental Health and Well-being of People Who Seek Help From Their Member of Parliament
Recruiting	`NCT05861843` - Craving Assessment in Patients With Alcohol Use Disorder Using Virtual Reality Exposure
Terminated	`NCT04404712` - FAAH Availability in Psychiatric Disorders: A PET Study	Early Phase 1
Enrolling by invitation	`NCT04128761` - Decreasing the Temporal Window in Individuals With Alcohol Use Disorder	N/A
Not yet recruiting	`NCT06163651` - Evaluating a One-Year Version of the Parent-Child Assistance Program	N/A
Not yet recruiting	`NCT06444243` - Psilocybin-assisted Therapy for Alcohol Use Disorder	Phase 2
Not yet recruiting	`NCT06337721` - Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults	N/A
Enrolling by invitation	`NCT02544581` - Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare	N/A