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| Name | Class |
|---|---|
| Otsuka America Pharmaceutical | INDUSTRY |
The purpose of this clinical research study is to learn whether subjects treated with aripiprazole are able to abstain from alcohol use for a greater number of days than subjects treated with placebo. The safety of using aripiprazole will also be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Active Comparator |
| |
| A2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Tablets, Oral, 2-30mg, Once daily, 12 weeks. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of abstinence from the consumption of alcohol during the study |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of alcohol use during the study and behavioral measures of substance abuse an dependence |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Farmington | Connecticut | United States | |||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18204334 | Derived | Anton RF, Kranzler H, Breder C, Marcus RN, Carson WH, Han J. A randomized, multicenter, double-blind, placebo-controlled study of the efficacy and safety of aripiprazole for the treatment of alcohol dependence. J Clin Psychopharmacol. 2008 Feb;28(1):5-12. doi: 10.1097/jcp.0b013e3181602fd4. |
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| Placebo | Drug | Tablets, Oral, Once daily, 12 weeks. |
|
| New Haven |
| Connecticut |
| United States |
| Local Institution | Indianapolis | Indiana | United States |
| Local Institution | Boston | Massachusetts | United States |
| Local Institution | New York | New York | United States |
| Local Institution | Rochester | New York | United States |
| Local Institution | Chapel Hill | North Carolina | United States |
| Local Institution | Philadelphia | Pennsylvania | United States |
| Local Institution | Providence | Rhode Island | United States |
| Local Institution | Charleston | South Carolina | United States |
| Local Institution | Dallas | Texas | United States |
| Local Institution | Houston | Texas | United States |
| Local Institution | Charlottesville | Virginia | United States |
| Local Institution | Milwaukee | Wisconsin | United States |
| 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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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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