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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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This study evaluates the effects of the medication GET73 among non-treatment-seeking individuals who regularly drink alcohol. Participants in the study will take GET73 or placebo for an 8-day study. There are 4 study visits including 2 MRI scans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Placebo Comparator |
| |
| Group B | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Participants will be getting placebo for 8 days of dosing. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of drinks consumed during bar-lab paradigm (free drinking period) | 165 minutes | |
| Change in Gamma aminobutyric acid (GABA) and glutamate levels | Acquired via spectroscopy sequence completed at baseline and day 7 scans | baseline to day 7 |
| Levels of cortical activation to visual cues of alcohol | Acquired via functional magnetic resonance imaging completed at baseline and day 7 scans | baseline to day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Prisciandaro | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charleston Alcohol Research Center, Institute of Psychiatry, Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
Per NOT-AA-19-020, this study will submit and share data with NIAAA Data Archive, a data repository housed within the NIMH Data Archive. This includes broad sharing of all research subjects' de-identified data.
De-identified participant data will be uploaded to the NIMH Data Archive twice yearly (by April 1 and October 1) during the course of this study, and will remain available with no end date.
Data and supporting documentation submitted to the NIMH Data Archive may be accessed and used broadly by approved users for research and other activities as authorized by and consistent with law.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 24, 2025 | Feb 2, 2026 | ICF_000.pdf |
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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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| GET73 |
| Drug |
Participants will be getting GET73 for 8 days of dosing. |
|