Back to resultsNefazodone in the Treatment of Cocaine Dependence and Depression - 4
Primary Purpose
Cocaine-Related Disorders, Substance-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nefazodone
Psychosocial Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring Cocaine Use Disorders Dependence Depression
Eligibility Criteria
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.
Sites / Locations
- Boston University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nefazodone
Matched Placebo Tablet
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Urine benzoylecgonine (BE) concentration
Natural log BE in urine samples collected weekly were analyzed for the baseline week and the subsequent 8 treatment weeks.
Secondary Outcome Measures
Hamilton Depression Scale (HAM-D)
HAM-D collected on a weekly basis.
Cocaine-Craving Scale
CCS scores were collected on a weekly basis.
Adverse Events Self Report
Data for adverse events were collected on a weekly basis
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.
Full Information
NCT ID
NCT00015210
First Posted
April 18, 2001
Last Updated
July 29, 2015
Sponsor
Boston Medical Center
Collaborators
Boston University
1. Study Identification
Unique Protocol Identification Number
NCT00015210
Brief Title
Nefazodone in the Treatment of Cocaine Dependence and Depression - 4
Official Title
Efficacy of Nefazodone in Cocaine Dependent Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
February 1997 (undefined)
Primary Completion Date
May 1999 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
Collaborators
Boston University
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and depression comorbidity.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders, Substance-Related Disorders
Keywords
Cocaine Use Disorders Dependence Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nefazodone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Matched Placebo Tablet
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nefazodone
Other Intervention Name(s)
Serzone
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial Treatment
Other Intervention Name(s)
Indivdual Manual-quided relapse prevention therapy, or Individual Dug Counseling
Intervention Description
All subjects attended a weekly 1-hour therapy session during the 8 week treatment period.
Primary Outcome Measure Information:
Title
Urine benzoylecgonine (BE) concentration
Description
Natural log BE in urine samples collected weekly were analyzed for the baseline week and the subsequent 8 treatment weeks.
Time Frame
Study Weeks Basekine to Week 8
Secondary Outcome Measure Information:
Title
Hamilton Depression Scale (HAM-D)
Description
HAM-D collected on a weekly basis.
Time Frame
Baseline through Study Week 8
Title
Cocaine-Craving Scale
Description
CCS scores were collected on a weekly basis.
Time Frame
Baseline through Week 8
Title
Adverse Events Self Report
Description
Data for adverse events were collected on a weekly basis
Time Frame
Study Weeks 1 through 8
Title
Alcohol Drug Use Inventory
Description
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.
Time Frame
Baseline through Study Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dom Ciraulo, M.D.
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15730347
Citation
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.
Results Reference
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Nefazodone in the Treatment of Cocaine Dependence and Depression - 4
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