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| Name | Class |
|---|---|
| Yale University | OTHER |
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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:
Researchers will compare the effects of NTX-2001 with matching placebo (look-alike capsule that contains no drug).
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NTX-2001 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTX-2001 | Drug | Daily (QD) x 2 weeks. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of drinks consumed during the alcohol drinking paradigm (ADP). | Day 0 to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs), vital signs, and clinical laboratory throughout the study. | Day 0 to Day 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Newleos Therapeutics Clinical Trial Team | Contact | 978-780-5937 | clinicaltrials@newleos.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine, Connecticut Mental Health Center | Recruiting | New Haven | Connecticut | 06519 | United States |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Drug |
Daily (QD) x 2 weeks. |
|