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Endotoxin

Endotoxin for Alcohol Consumption Behavior

Phase 2
Recruiting
Led By Terril Verplaetse, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Age 21-65
Must not have
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)
Subjects with medical conditions contraindicating alcohol use (e.g., liver enzymes ≥3× normal)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes

Summary

This trial will study the effects of endotoxin on drinking behavior in humans.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the side effects are not explicitly listed here, endotoxins typically cause symptoms like fever, chills, headaches, muscle pains and may affect various body systems which could potentially influence drinking behavior.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I drink more than the specified weekly limit for my gender.
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I am between 21 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or nursing and use effective birth control or am surgically sterile/postmenopausal.
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I cannot consume alcohol due to a medical condition.
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I do not have any major health issues like heart problems, kidney or liver disease, seizures, or HIV.
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I have not had severe mental health issues like schizophrenia, bipolar disorder, major depression, or anxiety in the past 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Alcohol consumption

Side effects data

From 2016 Phase 1 & 2 trial • 10 Patients • NCT00923910
100%
Platelets-low
80%
Glucose, serum-low (hypoglycemia)
80%
Hemoglobin-low
80%
Pruritis/itching
80%
Leukocytes (total WBC) - low
80%
Rash/desquamation
80%
Neutrophils/granulocytes (ANC/AGC) - low
60%
Sodium, serum-low (hyponatremia)
60%
ALT, SGPT (serum glutamic pyruvic transaminase) - high
60%
AST, SGOT (serum glutamic oxaloacetic transaminase) - high
60%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0x10e9/L)
60%
Pain: Abdomen NOS
40%
Supraventricular and nodal arrhythmia: sinus tachycardia
40%
Mood alteration:anxiety
40%
Albumin, serum low (hypoalbuminemia)
40%
Glucose (serum -high (hyperglycemia)
40%
Bicarbonate, serum low
40%
Diarrhea
40%
PTT (partial thromboplastin time)
40%
Magnesium, serum high (hypermagnesemia)
40%
Magnesium, serum low (hypomagnesemia)
40%
Pain: Head/Headache
40%
Potassium, serum-low (hypokalemia)
40%
Cough
40%
Nausea
40%
Pain: throat/pharynx/larynx
40%
Calcium, serum-low (hypocalcemia)
20%
Supraventricular and nodal arrhythmia: sinus bradycardia
20%
Potassium, serum-high (hyperkalemia)
20%
Phosphate, serum low (hypophosphatemia)
20%
Proteinuria
20%
Triglyceride, serum high (hypertriglyceridemia)
20%
Sodium, serum-high (hypernatremia)
20%
Infection with normal ANC or Grade 1 or 2 neutrophils:lung (pneumonia)
20%
Pain: chest wall
20%
Dry eye syndrome
20%
Infection with normal ANC or Grade 1 or 2 neutriphils:lung (pneumonia)
20%
GGT (gamma-Glutamyl transpeptidase)
20%
Allergy/Immunology - Other, Specify - allergy to Sorbaview
20%
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
20%
Insomnia
20%
Rigors/chills
20%
Pain: neck
20%
Cholesterol, serum-high (hypercholesteremia)
20%
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
20%
Hypotension
20%
Fatigue (asthenia, lethargy, malaise)
20%
Coagulation - Other, Specify - PT, prolonged
20%
Hemorrhage, pulmonary/upper respiratory: Nose
20%
Hepatobiliary/pancreas- Other, Specify - non-alcoholic Steatoheptits
20%
Esophagitis
20%
Febrile neutropenia
20%
Anorexia
20%
Iron overload
20%
Infection with unknown ANC:sinus
20%
Pain:muscle
20%
Pain:pain NOS
20%
Ocular/Visual - Other, Specify - Eye drainage
20%
Pain: Eye
20%
Striae
20%
Uric acid, serum high (hyperuricemia)
20%
Urinary frequency/urgency
20%
Vision-blurred vision
20%
Infection with normal ANC or Grade 1 or 2 neutrophils: upper airway NOS
20%
Pain:Joint
20%
Sweating (diaphoresis)
20%
Bilirubin (hyperbilirubinemia)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Recipients

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endotoxin
2008
Completed Phase 4
~660

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,919 Previous Clinical Trials
3,040,323 Total Patients Enrolled
91 Trials studying Alcoholism
10,945 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
833 Previous Clinical Trials
1,082,509 Total Patients Enrolled
456 Trials studying Alcoholism
823,741 Patients Enrolled for Alcoholism
Terril Verplaetse, PhDPrincipal InvestigatorYale University

Media Library

Endotoxin (Endotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT04527185 — Phase 2
Alcoholism Research Study Groups: Endotoxin, Placebo
Alcoholism Clinical Trial 2023: Endotoxin Highlights & Side Effects. Trial Name: NCT04527185 — Phase 2
Endotoxin (Endotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04527185 — Phase 2
~9 spots leftby Nov 2025
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