Endotoxin for Alcohol Consumption Behavior
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how endotoxin, a substance that can trigger immune responses, affects drinking behavior in people with alcohol use disorder. Participants will receive either endotoxin or a placebo (a harmless substance) during a lab session to observe any changes in their drinking habits. The study seeks adults who have been drinking heavily for the past few months, specifically those exceeding 14 drinks a week for men or 7 drinks for women and often consuming more in one sitting. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used psychoactive drugs like anxiolytics or antidepressants in the past 30 days.
Is there any evidence suggesting that this protocol is likely to be safe for humans?
Research has shown that people with alcohol use disorder (AUD) may have a weaker immune response to endotoxins. This results in a less pronounced increase in certain immune signals, such as TNF-α, IL-6, and IL-8. Although this might seem beneficial, endotoxins can still cause physical and mental discomfort. Thus, even with a milder immune response, other side effects may occur.
This trial is in Phase 2, indicating some evidence of the treatment's safety, with the main focus on its tolerability. Researchers are still assessing its safety for a broader population. Joining such a trial involves some risk but also offers an opportunity to contribute to scientific understanding.12345Why are researchers excited about this trial?
Most treatments for alcohol consumption behavior focus on behavioral therapy or medications like naltrexone and acamprosate, which help reduce the urge to drink. But endotoxin is different because it introduces a novel approach by using a small dose of bacterial endotoxin to potentially influence alcohol consumption behavior. This treatment works by triggering the immune system, which might affect brain pathways related to alcohol cravings. Researchers are excited about endotoxin because it could offer a new way to address alcohol use disorders by targeting the immune system, an area not typically explored with current medications.
What evidence suggests that endotoxin is effective for reducing alcohol consumption?
Studies have shown that endotoxin might affect drinking habits by influencing the immune system. Research suggests that introducing endotoxin can reduce the usual inflammatory response in people with alcohol use disorder, weakening the body's typical reaction to inflammation. Additionally, evidence indicates that endotoxin might help decrease certain drinking-related behaviors. In this trial, participants will receive either endotoxin or a placebo to further investigate these effects. Although this research is ongoing, these findings suggest that endotoxin could alter how people with alcohol use disorder react to drinking.13678
Who Is on the Research Team?
Terril Verplaetse, PhD
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of endotoxin or placebo during a laboratory session
Follow-up
Participants are monitored for drinking behavior and adverse events after the laboratory session
What Are the Treatments Tested in This Trial?
Interventions
- Endotoxin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator