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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Daily (QD) x 2 weeks.
Daily (QD) x 2 weeks.
Yale University School of Medicine, Connecticut Mental Health Center
New Haven, Connecticut, United States
RECRUITINGNumber of drinks consumed during the alcohol drinking paradigm (ADP).
Time frame: Day 0 to Day 14
Incidence and severity of treatment-emergent adverse events (TEAEs), vital signs, and clinical laboratory throughout the study.
Time frame: Day 0 to Day 21
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