Nefazodone in the Treatment of Cocaine Dependence and Depression - 4

Study Overview
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Brief Summary
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The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and depression comorbidity.

Detailed Description
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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.

Official Title
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Efficacy of Nefazodone in Cocaine Dependent Subjects

Conditions
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Cocaine-Related Disorders, Substance-Related Disorders

Intervention / Treatment
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* Drug: Nefazodone
* Behavioral: Psychosocial Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nefazodone<br>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. | Drug: Nefazodone<br> <br> * Other names: Serzone;Behavioral: Psychosocial Treatment<br>* All subjects attended a weekly 1-hour therapy session during the 8 week treatment period.<br>* Other names: or Individual Dug Counseling;|
| Placebo Comparator: Matched Placebo Tablet<br>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. | Drug: Nefazodone<br> <br> * Other names: Serzone;Behavioral: Psychosocial Treatment<br>* All subjects attended a weekly 1-hour therapy session during the 8 week treatment period.<br>* Other names: or Individual Dug Counseling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cocaine Use Disorders Dependence Depression