Actively Recruiting
Study of NTX-2001 on Alcohol Consumption in Alcohol Use Disorder
Led by Newleos Therapeutics, Inc. · Updated on 2026-04-09
50
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
Sponsors
N
Newleos Therapeutics, Inc.
Lead Sponsor
Y
Yale University
Collaborating Sponsor
AI-Summary
What this Trial 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). 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
CONDITIONS
Official Title
Study of NTX-2001 on Alcohol Consumption in Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent and agree to follow the study rules
- Speak English
- Male or female between 21 and 60 years old
- Body mass index between 18 and 35 kg/m2
- Meet DSM-5 criteria for Alcohol Use Disorder confirmed by MINI
- If of childbearing potential, agree to use highly effective birth control during the study and for 14 days after last dose
You will not qualify if you...
- Currently seeking alcohol treatment or have had alcohol treatment in the past 6 months
- Dislike spirits (hard liquor)
- Have a current substance use disorder except tobacco or mild cannabis use disorder
- Have schizophrenia spectrum or other psychotic disorder
- Regularly taking psychotropic drugs except stable antidepressant dose for 2 months prior to screening
- At risk for suicidal thoughts as per C-SSRS
- Have moderate or severe liver impairment
- Have moderate or severe kidney impairment
- Women who are pregnant or breastfeeding and do not plan to stop breastfeeding during the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Yale University School of Medicine, Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
Research Team
N
Newleos Therapeutics Clinical Trial Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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