Alcohol Use Disorder
Conditions
Brief summary
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
Interventions
DRUGNTX-2001
Daily (QD) x 2 weeks.
DRUGPlacebo
Daily (QD) x 2 weeks.
Sponsors
Newleos Therapeutics, Inc.
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of drinks consumed during the alcohol drinking paradigm (ADP). | Day 0 to Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs), vital signs, and clinical laboratory throughout the study. | Day 0 to Day 21 |
Countries
United States
Contacts
CONTACTNewleos Therapeutics Clinical Trial Team
Outcome results
None listed