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| ID | Type | Description | Link |
|---|---|---|---|
| Y01-5-0013-4 |
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| Name | Class |
|---|---|
| Boston University | OTHER |
The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and depression comorbidity.
The objective of this study is to determine the safety and efficacy of nefazodone (Serzone ) in depressed cocaine dependent subjects. This is a hypothesis-testing study which will explore whether cocaine usage will be reduced in the nefazodone treatment group compared to a placebo control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nefazodone | Active Comparator | Nefazodone 100 mg tablet, titrated to a maximum of 200 mg administered twice daily by treatment day 10. Drug tapered over 7 days at the conclusion of the treatment period. Treatment was administered for 8 weeks. |
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| Matched Placebo Tablet | Placebo Comparator | Matched placebo tablet, titrated up to 2 tablets twice daily by day 10 and tapered over 7 days at the conclusion of the study. Treatment period lasted 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nefazodone | Drug |
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| Psychosocial Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Urine benzoylecgonine (BE) concentration | Natural log BE in urine samples collected weekly were analyzed for the baseline week and the subsequent 8 treatment weeks. | Study Weeks Basekine to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Scale (HAM-D) | HAM-D collected on a weekly basis. | Baseline through Study Week 8 |
| Cocaine-Craving Scale | CCS scores were collected on a weekly basis. |
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Inclusion Criteria:
DSM-IV diagnosis of cocaine dependence, Depression score of 12 or above and history of depression. Males and non-pregnant, non-nursing females 21-55 years of age.
Exclusion Criteria:
Axis I diagnosis other than substance use disorder, major depression, anxiety of dysthymic disorder. Physiological dependence on alcohol. Significant medical or neurological history. Abnormal UA, CBC or Chem 23 (LFT's may be up to 3 times normal). Enrollment in an opiate-substitution treatment program within 45 days of enrollment in the present study.
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| Name | Affiliation | Role |
|---|---|---|
| Dom Ciraulo, M.D. | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15730347 | Background | Ciraulo DA, Knapp C, Rotrosen J, Sarid-Segal O, Ciraulo AM, LoCastro J, Greenblatt DJ, Leiderman D. Nefazodone treatment of cocaine dependence with comorbid depressive symptoms. Addiction. 2005 Mar;100 Suppl 1:23-31. doi: 10.1111/j.1360-0443.2005.00984.x. |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C051752 | nefazodone |
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| Behavioral |
All subjects attended a weekly 1-hour therapy session during the 8 week treatment period. |
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| Baseline through Week 8 |
| Adverse Events Self Report | Data for adverse events were collected on a weekly basis | Study Weeks 1 through 8 |
| Alcohol Drug Use Inventory | Subjects were asked about the amount of cocaine consumed and the number of days in cocaine was used in the previous week, on a weekly basis. | Baseline through Study Week 8 |