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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

NTX-2001
Drug
Daily (QD) x 2 weeks.
Placebo
Drug
Daily (QD) x 2 weeks.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: NTX-2001Experimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Number of drinks consumed during the alcohol drinking paradigm (ADP).

Time frame

Day 0 to Day 14

Secondary outcomes

Incidence and severity of treatment-emergent adverse events (TEAEs), vital signs, and clinical laboratory throughout the study.

Time frame

Day 0 to Day 21

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Newleos Therapeutics, Inc.

Lead sponsor

Yale University

Collaborator

Source ClinicalTrials.gov

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