Study of NTX-2001 on Alcohol Consumption in Alcohol Use Disorder

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Newleos Therapeutics, Inc.
Study ID
NCT07520292
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • NTX-2001 — DRUG
    Daily (QD) x 2 weeks.
  • Placebo — DRUG
    Daily (QD) x 2 weeks.

Study Details

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

Key Dates

Start date
Mar 20, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NTX-2001
  • Placebo Comparator: Placebo

Primary Outcome Measure

Number of drinks consumed during the alcohol drinking paradigm (ADP). [ Time Frame: Day 0 to Day 14 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale University School of Medicine, Connecticut Mental Health CenterNew HavenConnecticut06519
Yale University School of Medicine, Connecticut Mental Health
[email protected]
978-780-5937

Find similar trials in New Haven, CT

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Yale University School of Medicine, Connecticut Mental Health Center· New Haven, CT

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