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| Tracking Information | |||||
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| First Received Date ICMJE | April 18, 2001 | ||||
| Last Updated Date | August 28, 2008 | ||||
| Start Date ICMJE | February 1997 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00015210 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Nefazodone in the Treatment of Cocaine Dependence and Depression - 4 | ||||
| Official Title ICMJE | Efficacy of Nefazodone in Cocaine Dependent Subjects | ||||
| Brief Summary | The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and depression comorbidity. |
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| Detailed Description | 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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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Placebo Control | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Nefazodone | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 0 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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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| Gender | Both | ||||
| Ages | 21 Years to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00015210 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | NIDA-5-0013-4, Y01-5-0013-4 | ||||
| Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Collaborators ICMJE | New York MDRU | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Drug Abuse (NIDA) | ||||
| Verification Date | August 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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