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

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