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Endotoxin Challenge for Alcoholism

Phase 2
Waitlist Available
Led By Lara Ray, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between the ages of 21 and 45
For heavy drinkers: Report drinking at binge levels at least 1 time in the past month (5+ drinks/day for men, 4+ drinks/day for women); For light drinkers: report no occasions of binge drinking in the past month
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the prt and rrs will be completed at 2 timepoints during the experimental visit. specifically, reward responsiveness will be assessed at baseline (prior to infusion) and 2 hours post-infusion of placebo or low dose endotoxin.
Awards & highlights

Study Summary

This trial is testing the effects of low dose endotoxin on heavy drinkers and light drinkers. The study design is double-blind and placebo-controlled.

Who is the study for?
This trial is for men and women aged 21-45 who drink alcohol but aren't seeking treatment. Heavy drinkers must have binged at least once in the past month, while light drinkers shouldn't have binged. Participants should be healthy without severe depression or drug use disorders, not pregnant or nursing, and willing to use birth control if applicable.Check my eligibility
What is being tested?
The study tests how a low dose of endotoxin affects inflammation compared to a placebo. It's randomized and double-blind, meaning neither participants nor researchers know who gets what. The test involves an IV infusion followed by assessments of mood, cravings, and brain responses related to alcohol cues.See study design
What are the potential side effects?
Potential side effects include temporary systemic inflammatory response with symptoms like fever or chills due to cytokine release after the endotoxin infusion. These are expected to normalize within hours post-infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 45 years old.
Select...
I am a heavy drinker if I'm a man who had 5+ drinks/day or a woman who had 4+ drinks/day at least once last month. I am a light drinker if I had no such occasions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the prt and rrs will be completed at 2 timepoints during the experimental visit. specifically, reward responsiveness will be assessed at baseline (prior to infusion) and 2 hours post-infusion of placebo or low dose endotoxin.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the prt and rrs will be completed at 2 timepoints during the experimental visit. specifically, reward responsiveness will be assessed at baseline (prior to infusion) and 2 hours post-infusion of placebo or low dose endotoxin. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in depressed mood
Cue-induced craving
Secondary outcome measures
Change in reward responsiveness
Effect on neural alcohol cue-reactivity

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%
Febrile neutropenia
20%
Insomnia
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
Bolus dose of endotoxin (0.8 ng/kg)
Group II: PlaceboPlacebo Group1 Intervention
Matched to endotoxin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Escherichia coli
Not yet FDA approved

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,528 Previous Clinical Trials
10,276,831 Total Patients Enrolled
1 Trials studying Craving
Lara Ray, PhDPrincipal InvestigatorUniversity of California, Los Angeles
6 Previous Clinical Trials
340 Total Patients Enrolled

Media Library

Endotoxin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04310423 — Phase 2
Craving Research Study Groups: Placebo, Endotoxin
Craving Clinical Trial 2023: Endotoxin Highlights & Side Effects. Trial Name: NCT04310423 — Phase 2
Endotoxin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04310423 — Phase 2

Frequently Asked Questions

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

Are there long-term repercussions to prescription Endotoxin?

"Endotoxin received a score of 2 on our team's 1-3 scale because, while there is some data supporting safety, no clinical evidence exists yet to support efficacy."

Answered by AI

Could people who are over the age of 45 still participate in this research?

"For this specific clinical trial, only patients aged 21 to 45 are eligible. In contrast, there are 22 other trials involving patients under 18 and 235 studies for individuals over the age of 65."

Answered by AI

How can I become a part of this research project?

"This trial is open to 76 individuals that report experiencing cravings and meet the following eligibility requirements: Be aged between 21 and 45, have consumed at least one alcoholic beverage in the last month, score 8-15 on the Alcohol Use Disorder Identification Test for heavy drinkers or less than 4 for light drinkers, self-report no occasions of binge drinking in the past month for light drinkers or at least one occasion of binge drinking for heavy drinkers."

Answered by AI

What are some of the common ailments that doctors use Endotoxin to treat?

"urethritis is most commonly treated with Endotoxin. However, this medication can also treat other conditions like urinary tract infection, irritable bowel syndrome (ibs), and bacteriuria."

Answered by AI

What else is known about Endotoxin from other scientific research?

"Currently, there is one clinical trial underway for endotoxin research. This study has not yet reached phase 3. Most of the trials related to endotoxin are based in Los Angeles, but there is also one location outside of California conducting these kinds of studies."

Answered by AI

Are individuals currently being sought out for this experiment?

"That is correct. The clinical trial, which was created on 10/19/2021, is still looking for patients according to information found on clinicaltrials.gov. So far, 1 location has been identified and 76 individuals are needed in total."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
65+
What site did they apply to?
UCLA Addictions Laboratory
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
An Inflammatory Challenge Using Endotoxin
Lara Ray, PhD 2021. "An Inflammatory Challenge Using Endotoxin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04310423.
~6 spots leftby Apr 2025
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