Overview
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
Eligibility
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
