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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA019804 | U.S. NIH Grant/Contract | View source | |
| DPMCDA | Other Identifier | NIDA |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to evaluate the effects of Topiramate and Cognitive Behavioral Therapy for the treatment of alcohol and cocaine dependence.
Our objective is to understand the basic mechanisms that underpin substance dependence, and to develop efficacious treatments for individuals with comorbid cocaine and alcohol dependence.
Participants in this study will be randomly assigned to receive either 300 mg per day of topiramate or placebo. In addition, participants will receive weekly cognitive behavioral therapy for 12 weeks.Follow-up visits will occur at 2 weeks and 1,2,, and 3 months following completion of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topiramate | Experimental | Topiramate + Cognitive Behavioral Therapy |
|
| Placebo | Placebo Comparator | Placebo + Cognitive Behavioral Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiramate + Cognitive Behavioral Therapy | Drug | Topiramate up to 300 mg per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| The topiramate group will be superior to the placebo group on the following outcome measures:increasing the weekly mean proportion of cocaine-free days, decreasing self-reported drinking, and decreasing craving for cocaine and alcohol. | Alcohol - assessed by self-report of use (TLFB,DD,DDD,PDA, PHDD), biochemical markers (GGT, CDT), OCDS Cocaine - assessed by self-report of use (CTFB, substance use inventory, QFI),urine assay for benzoylecgonine, and CCQ-NOW | According to Preston Rules from weeks 6 to 12. |
| Measure | Description | Time Frame |
|---|---|---|
| a. Cocaine free weeks; b. Topiramate, compared with placebo, will be associated with an improvement in psychosocial functioning as exemplified by improved general well-being, social functioning, and quality of life. |
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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 |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077236 | Topiramate |
| D015928 | Cognitive Behavioral Therapy |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D002241 | Carbohydrates |
| D007661 |
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| Placebo + Cognitive Behavioral Therapy | Drug | Placebo twice a day |
|
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| According to Preston Rules from weeks 1 to 12 |
| University of Virginia Center for Addiction Research and Education | Recruiting | Richmond | Virginia | 23294 | United States |
|
| Ketoses |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |