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New pill aims to curb alcohol cravings in early trial

NCT ID NCT07520292

Disease control Sponsor: Newleos Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new drug called NTX-2001 in 50 adults with alcohol use disorder. Participants take the drug or a placebo daily for two weeks. Researchers will measure how much alcohol they drink and check for side effects. The goal is to see if this drug can safely reduce drinking.

What this could mean

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

Active substance
NTX-2001 (a drug that targets a brain receptor to reduce alcohol cravings)
What this could lead to
If successful, this could point toward a new medication to help people with alcohol use disorder drink less.
What could go wrong
This is a very early (Phase 1b) proof-of-concept study with only 50 people. It may not show a clear benefit, and the drug could have side effects.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

21 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. Has provided written informed consent for the study and is willing to comply with all requirements of the protocol 2. English speaker 3. Male or female, ≥21 and ≤60 years of age. 4. Has a body mass index (BMI) 18 to 35 kg/m2 inclusive. 5. Meets DSM-5 criteria for Alcohol Use Disorder (AUD) confirmed by Mini-International Neuropsychiatric Interview (MINI). 6. If participant is of childbearing potential, must commit to practicing highly effective methods of birth control during the study and at least 14 days after the last dose. Exclusion Criteria: 1. Currently seeking alcohol treatment or have been in alcohol treatment within the past 6 months 2. Reports disliking spirits (hard liquor) 3. Current diagnosis of substance use disorder, except for tobacco use disorder or mild cannabis use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) 4. Past or current diagnosis of schizophrenia spectrum or other psychotic disorder as defined by the DSM-5 5. Receiving psychotropics regularly, except for a stable dose of an antidepressant for at least 2 months prior to Screening 6. Is at risk for suicidal ideation as per C-SSRS 7. Has moderate or severe hepatic impairment 8. Has moderate or severe renal impairment 9. Women who are pregnant or women who are currently breastfeeding unless they plan to stop breastfeeding for the duration of the study

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Conditions

The condition(s) this trial relates to.

alcohol abuse

As listed by the trial registrant

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

Alcohol use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Yale University School of Medicine, Connecticut Mental Health Center

    RECRUITING

    New Haven, Connecticut, 06519, United States

    Contact Email: •••••@•••••

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