NCT07520292 Study of NTX-2001 on Alcohol Consumption in Alcohol Use Disorder
| NCT ID | NCT07520292 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Newleos Therapeutics, Inc. |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-03-20 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2026-03-20 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Has provided written informed consent for the study and is willing to comply with all requirements of the protocol 2. English speaker 3. Male or female, ≥21 and ≤60 years of age. 4. Has a body mass index (BMI) 18 to 35 kg/m2 inclusive. 5. Meets DSM-5 criteria for Alcohol Use Disorder (AUD) confirmed by Mini-International Neuropsychiatric Interview (MINI). 6. 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. Exclusion Criteria: 1. Currently seeking alcohol treatment or have been in alcohol treatment within the past 6 months 2. Reports disliking spirits (hard liquor) 3. 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) 4. Past or current diagnosis of schizophrenia spectrum or other psychotic disorder as defined by the DSM-5 5. Receiving psychotropics regularly, except for a stable dose of an antidepressant for at least 2 months prior to Screening 6. Is at risk for suicidal ideation as per C-SSRS 7. Has moderate or severe hepatic impairment 8. Has moderate or severe renal impairment 9. Women who are pregnant or women who are currently breastfeeding unless they plan to stop breastfeeding for the duration of the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07520292 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 60 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07520292 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07520292 currently recruiting?
Yes, NCT07520292 is actively recruiting participants. Contact the research team at clinicaltrials@newleos.com for enrollment information.
Where is the NCT07520292 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT07520292 clinical trial?
NCT07520292 is sponsored by Newleos Therapeutics, Inc.. The trial plans to enroll 50 participants.