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New treatment option for Alcohol Use Disorder
Official title Study of NTX-2001 on Alcohol Consumption in Alcohol Use Disorder
ClinicalTrials.gov ID: NCT07520292
What this study is testing
What is NTX-2001?
NTX-2001 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for alcohol use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 60
You may be able to join if
- 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.
- Meets DSM-5 criteria for Alcohol Use Disorder (AUD) confirmed by Mini-International Neuropsychiatric Interview (MINI).
You likely can't join if
- 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...
- Past or current diagnosis of schizophrenia spectrum or other psychotic disorder as defined by the DSM-5
- Receiving psychotropics regularly, except for a stable dose of an antidepressant for at least 2 months prior to Screening
- Is at risk for suicidal ideation as per C-SSRS
See the full eligibility criteria
- 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.
- Meets DSM-5 criteria for Alcohol Use Disorder (AUD) confirmed by Mini-International Neuropsychiatric Interview (MINI).
- 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.
- 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
- Receiving psychotropics regularly, except for a stable dose of an antidepressant for at least 2 months prior to Screening
- Is at risk for suicidal ideation as per C-SSRS
- Has moderate or severe hepatic impairment
- Has moderate or severe renal impairment
- Women who are pregnant or women who are currently breastfeeding unless they plan to stop breastfeeding for the duration of the study
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.