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NCT Number: NCT07520292

Study of NTX-2001 on Alcohol Consumption in Alcohol Use Disorder

The primary goal of this Phase 1b clinical trial is to evaluate the effects of a novel TAAR1 receptor partial agonist (NTX-2001) in adults with Alcohol Use Disorder (AUD). The main questions this trial aims to answer are:

* Does NTX-2001 affect alcohol consumption in adults with AUD? * Is NTX-2001 safe and well tolerated in adults with AUD?

Researchers will compare the effects of NTX-2001 with matching placebo (look-alike capsule that contains no drug).

Participants will:

* Take NTX-2001 or matching placebo every day for 2 weeks * Visit the clinic 4 times over the course of 10 weeks

Recruiting

Interested in participating?

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale University School of Medicine, Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location status: Recruiting

Location contact

Yale University School of Medicine, Connecticut Mental Health

CONTACT

[email protected]

978-780-5937

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has provided written informed consent for the study and is willing to comply with all requirements of the protocol
  • English speaker
  • Male or female, ≥21 and ≤60 years of age.
  • Has a body mass index (BMI) 18 to 35 kg/m2 inclusive.
  • Meets DSM-5 criteria for Alcohol Use Disorder (AUD) confirmed by Mini-International Neuropsychiatric Interview (MINI).
  • 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

  • Currently seeking alcohol treatment or have been in alcohol treatment within the past 6 months
  • Reports disliking spirits (hard liquor)
  • 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)
  • Past or current diagnosis of schizophrenia spectrum or other psychotic disorder as defined by the DSM-5
  • Receiving psychotropics regularly, except for a stable dose of an antidepressant for at least 2 months prior to Screening
  • Is at risk for suicidal ideation as per C-SSRS
  • Has moderate or severe hepatic impairment
  • Has moderate or severe renal impairment
  • Women who are pregnant or women who are currently breastfeeding unless they plan to stop breastfeeding for the duration of the study

Treatment and study plan

NTX-2001

Drug

Daily (QD) x 2 weeks.

Placebo

Drug

Daily (QD) x 2 weeks.

Primary outcomes

  1. Number of drinks consumed during the alcohol drinking paradigm (ADP).

    Time frame: Day 0 to Day 14

Secondary outcomes

  1. Incidence and severity of treatment-emergent adverse events (TEAEs), vital signs, and clinical laboratory throughout the study.

    Time frame: Day 0 to Day 21

Study contacts

Contact information is provided by the study sponsor or research team.

Newleos Therapeutics Clinical Trial Team

CONTACT

[email protected]

978-780-5937

Sponsors and collaborators

Lead sponsor

Newleos Therapeutics, Inc.

Industry

Collaborators

  • Yale University

Registry information

Official study title

The Effects of NTX-2001, a Novel TAAR1 Partial Agonist, on Alcohol Consumption in Adults With Alcohol Use Disorder: A Phase 1b, Randomized, Placebo-Controlled, Proof-of-Concept Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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