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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA013964 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.
This study is a 13 week clinical trial. During the 13 weeks participants receive placebo, ondansetron and topiramate alone or in combination. During the 13 weeks participants come to an outpatient clinic to receive the study medication, physical checks, and cognitive behavioral therapy. The duration of the weekly visit is 3 hours. There is a 1, 2, and 3 month post-study follow up visit. Screening for this study is initially done over the telephone and takes 15-20 minutes. If there is nothing found to make someone ineligible to participate, they come to the out-patient clinic for a more thorough in-clinic screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ondansetron | Experimental | Ondansetron + cognitive behavioral therapy |
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| Topiramate | Experimental | Topiramate + cognitive behavioral therapy |
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| Placebo | Placebo Comparator | Placebo + cognitive behavioral therapy |
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| Ondansetron + Topiramate | Experimental | Ondansetron + Topiramate + cognitive behavioral therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ondansetron + cognitive behavioral therapy | Drug | ondansetron (4 mcg/kg b.i.d) |
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| Measure | Description | Time Frame |
|---|---|---|
| Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption | Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT | Throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors | Pill Count, Q-LES-Q, SFQ, AASE, ADBS, OCDS, CIWA-Ar, CGI, TCI, MAC, AOQ, FHAM | Throughout the study |
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Inclusion Criteria:
Exclusion Criteria:
Please contact site for additional information
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mindy Borszich | Contact | 1-888-882-2345 | mcb3x@virginia.edu | |
| Eva Jenkins-Mendoza | Contact | (434) 243-0562 | emj9c@virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bankole Johnson, DSc, MD, PhD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Center for Addiction Research and Education | Recruiting | Charlottesville | Virginia | 22911 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15330732 | Background | Johnson BA. An overview of the development of medications including novel anticonvulsants for the treatment of alcohol dependence. Expert Opin Pharmacother. 2004 Sep;5(9):1943-55. doi: 10.1517/14656566.5.9.1943. |
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| topiramate + cognitive behavioral therapy | Drug | topiramate (up to 300 mg/day) |
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| Placebo + cognitive behavioral therapy | Drug | placebo |
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| ondansetron + topiramate + cognitive behavioral therapy | Drug | ondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day) |
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| University of Virginia Center for Addiction Research and Education | Recruiting | Richmond | Virginia | 23294 | 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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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| D015928 | Cognitive Behavioral Therapy |
| D000077236 | Topiramate |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D002241 | Carbohydrates |
| D007661 | Ketoses |
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