NTX-2001 for reducing alcohol use in adults with alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

NTX-2001, a TAAR1 receptor partial agonist, is given daily for two weeks and compared with a matching placebo in adults with alcohol use disorder. This Phase 1b trial emphasizes safety and tolerability while collecting early data on alcohol consumption, with participants attending four clinic visits over a 10-week period. Eligible participants are adults aged 21–60 with DSM-5–confirmed AUD and BMI between 18 and 35 kg/m2, and those currently seeking formal alcohol treatment are excluded. The study is sponsored by Newleos Therapeutics and conducted in collaboration with Yale University School of Medicine.

Why it matters

Who can join: the full rules

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

Where it's running

• Yale University School of Medicine, Connecticut Mental Health Center
  New Haven, Connecticut, United States Recruiting

Study contacts

• Study coordinator: Newleos Therapeutics Clinical Trial Team
• Email: clinicaltrials@newleos.com
• Phone: 978-780-5937

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.