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Bacterial toxin may fuel alcohol cravings in heavy drinkers

NCT ID NCT04527185

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a bacterial toxin called endotoxin can increase alcohol consumption in people with alcohol use disorder. 27 participants received either endotoxin or a placebo, and their alcohol intake was measured during a 2-hour session. The goal was to gather early data on how inflammation might affect drinking behavior.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Endotoxin (lipopolysaccharide)
What this could lead to
If this study shows a link, it could point toward new ways to understand and treat alcohol use disorder by targeting inflammation.
What could go wrong
This is a small, early-phase pilot study with only 27 people. The results may not apply to everyone with alcohol use disorder, and the findings are preliminary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

27 people

The number who actually took part.

Started

Feb 2022

Finished

Oct 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 21-65; 2. Able to read and write English; 3. Meets DSM-5 criteria for current (past 6 months) alcohol use disorder; 4. 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. 5. Must meet drinking criteria during a consecutive 30-day period within the 90 days prior to baseline; 6. Laboratory sessions will be scheduled such that subjects will not have major responsibilities on the following day which might limit drinking during the self-administration session (e.g., job interview, exam). 7. Negative urine pregnancy test for women. Exclusion Criteria: 1. Participants with any significant current medical conditions (neurological, cardiovascular \[including hypertension or hypotension: sitting BP \>160/100 or \<90/60mmHg at baseline screening\], endocrine, thyroid, renal, liver), seizures, delirium or hallucinations, or other unstable medical conditions including HIV; 2. Current DSM-5 substance use disorders, other than alcohol or nicotine; 3. A positive test result at intake appointment on urine drug screens conducted for illicit drugs, excluding cannabis; 4. Past 30 day use of psychoactive drugs including anxiolytics and antidepressants; 5. 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); 6. Suicidal, homicidal or evidence of current (past 6-month) severe mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders; 7. Subjects treatment-seeking or who are currently in treatment for alcohol use; 8. Subjects with medical conditions contraindicating alcohol use (e.g., liver enzymes ≥3× normal); 9. Subjects likely to exhibit clinically significant alcohol withdrawal during the study. We will exclude subjects who a) have a history of perceptual distortions, seizures, delirium, or hallucinations upon withdrawal, or b) have a score of \> 8 on the Clinical Institute Withdrawal Assessment scale at intake appointments; 10. Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current application. 11. Subjects \>38 on the Alcohol Use Disorders Identification Test (AUDIT) 12. Subjects with resting pulse \>100 at challenge 13. Subjects with recent (past 2 weeks) acute illness or vaccination 14. Subjects with \>Grade 2 laboratory abnormalities on screening

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Yale School of Medicine

    New Haven, Connecticut, 06519, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.