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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I drink more than the specified weekly limit for my gender.
Select...
I am between 21 and 65 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alcohol consumption

Side effects data

From 2016 Phase 1 & 2 trial • 10 Patients • NCT00923910
100%
Platelets-low
80%
Glucose, serum-low (hypoglycemia)
80%
Neutrophils/granulocytes (ANC/AGC) - low
80%
Rash/desquamation
80%
Leukocytes (total WBC) - low
80%
Pruritis/itching
80%
Hemoglobin-low
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
60%
Sodium, serum-low (hyponatremia)
60%
ALT, SGPT (serum glutamic pyruvic transaminase) - high
40%
Bicarbonate, serum low
40%
Albumin, serum low (hypoalbuminemia)
40%
Cough
40%
Magnesium, serum high (hypermagnesemia)
40%
Magnesium, serum low (hypomagnesemia)
40%
Nausea
40%
Potassium, serum-low (hypokalemia)
40%
Glucose (serum -high (hyperglycemia)
40%
Pain: Head/Headache
40%
Supraventricular and nodal arrhythmia: sinus tachycardia
40%
Mood alteration:anxiety
40%
Pain: throat/pharynx/larynx
40%
PTT (partial thromboplastin time)
40%
Calcium, serum-low (hypocalcemia)
40%
Diarrhea
20%
Insomnia
20%
Febrile neutropenia
20%
Hemorrhage, pulmonary/upper respiratory: Nose
20%
Hypotension
20%
Fatigue (asthenia, lethargy, malaise)
20%
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
20%
Hepatobiliary/pancreas- Other, Specify - non-alcoholic Steatoheptits
20%
Infection with normal ANC or Grade 1 or 2 neutriphils:lung (pneumonia)
20%
GGT (gamma-Glutamyl transpeptidase)
20%
Dry eye syndrome
20%
Esophagitis
20%
Iron overload
20%
Ocular/Visual - Other, Specify - Eye drainage
20%
Pain: Eye
20%
Supraventricular and nodal arrhythmia: sinus bradycardia
20%
Pain:pain NOS
20%
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
20%
Anorexia
20%
Allergy/Immunology - Other, Specify - allergy to Sorbaview
20%
Coagulation - Other, Specify - PT, prolonged
20%
Pain:Joint
20%
Rigors/chills
20%
Striae
20%
Sweating (diaphoresis)
20%
Triglyceride, serum high (hypertriglyceridemia)
20%
Uric acid, serum high (hyperuricemia)
20%
Urinary frequency/urgency
20%
Vision-blurred vision
20%
Potassium, serum-high (hyperkalemia)
20%
Phosphate, serum low (hypophosphatemia)
20%
Pain: chest wall
20%
Pain: neck
20%
Infection with normal ANC or Grade 1 or 2 neutrophils:lung (pneumonia)
20%
Infection with normal ANC or Grade 1 or 2 neutrophils: upper airway NOS
20%
Pain:muscle
20%
Proteinuria
20%
Sodium, serum-high (hypernatremia)
20%
Infection with unknown ANC:sinus
20%
Bilirubin (hyperbilirubinemia)
20%
Cholesterol, serum-high (hypercholesteremia)
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
~500

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
796 Previous Clinical Trials
1,361,391 Total Patients Enrolled
420 Trials studying Alcoholism
984,913 Patients Enrolled for Alcoholism
Yale UniversityLead Sponsor
1,841 Previous Clinical Trials
2,734,495 Total Patients Enrolled
82 Trials studying Alcoholism
10,204 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Endotoxin completed the necessary steps for FDA approval?

"There is early data supporting the safety of this medication, but nothing yet for efficacy. Consequently, we've given it a score of 2."

Answered by AI

Does this research project allow people who are octogenarians to participate?

"According to the study's eligibility requirements, participants must be between 21 and 65 years old. Out of the 300 active trials, this is one of 34 that accept patients below 18 or above 65."

Answered by AI

Are researchers actively looking for more participants for this trial?

"The online database clinicaltrials.gov indicates that this study is still looking for participants. This information was originally posted on January 27th, 2022 and last updated April 21st of the same year."

Answered by AI

To whom is this trial open?

"To qualify for this study, individuals must suffer from alcoholism and be between 21-65 years old. Only 32 patients will be accepted in total."

Answered by AI

How many people are being treated with this new medication?

"Yes, the information available on clinicaltrials.gov suggests that this research is ongoing and presently looking for more participants. The study was first made public on 1/27/2022 with the most recent update being on 4/21/2022. At the moment, 32 patients are needed at a single location."

Answered by AI
~2 spots leftby May 2024