Study of NTX-2001 on Alcohol Consumption in Alcohol Use Disorder
ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-60
SponsorNewleos Therapeutics, Inc.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- NTX-2001
- Placebo
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Newleos Therapeutics, Inc.
Lead sponsor
Yale University
Collaborator
Source ClinicalTrials.gov