Who is eligible for clinical trial NCT07520292?

Participants must meet protocol criteria for Alcohol Use Disorder. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07520292 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-03

Study of NTX-2001 on Alcohol Consumption in Alcohol Use Disorder (NCT07520292)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Newleos Therapeutics, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (10 items).

Location: Yale University School of Medicine, Connecticut Mental Health Center — New Haven, Connecticut

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Yale University School of Medicine, Connecticut Mental Health Center — New Haven, Connecticut

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗