NCT07520292 · Newleos Therapeutics, Inc.
Study of NTX-2001 on Alcohol Consumption in Alcohol Use Disorder
What this study is about
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).
View original scientific description
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).
Interventions
DRUG
NTX-2001
Daily (QD) x 2 weeks.
DRUG
Placebo
Daily (QD) x 2 weeks.
Primary outcome measures
Number of drinks consumed during the alcohol drinking paradigm (ADP).
Time frame: Day 0 to Day 14
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New Haven, Connecticut
Collaborators
Yale University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 9, 2026 · Source of record for eligibility and locations