Nefazodone in the Treatment of Cocaine Dependence and Depression - 4

This study has been completed.
Sponsor:
Collaborator:
Boston University
Information provided by (Responsible Party):
Dominic Ciraulo, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00015210
First received: April 18, 2001
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Cocaine-Related Disorders
Substance-Related Disorders
Drug: Nefazodone
Behavioral: Psychosocial Treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Nefazodone in Cocaine Dependent Subjects

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Urine benzoylecgonine (BE) concentration [ Time Frame: Study Weeks Basekine to Week 8 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline through Study Week 8 ] [ Designated as safety issue: No ]
    HAM-D collected on a weekly basis.

  • Cocaine-Craving Scale [ Time Frame: Baseline through Week 8 ] [ Designated as safety issue: No ]
    CCS scores were collected on a weekly basis.

  • Adverse Events Self Report [ Time Frame: Study Weeks 1 through 8 ] [ Designated as safety issue: Yes ]
    Data for adverse events were collected on a weekly basis

  • Alcohol Drug Use Inventory [ Time Frame: Baseline through Study Week 8 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 69
Study Start Date: February 1997
Primary Completion Date: May 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nefazodone
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
Other Name: Serzone
Behavioral: Psychosocial Treatment
All subjects attended a weekly 1-hour therapy session during the 8 week treatment period.
Other Names:
  • Indivdual Manual-quided relapse prevention therapy
  • or Individual Dug Counseling
Placebo Comparator: Matched Placebo Tablet
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
Other Name: Serzone
Behavioral: Psychosocial Treatment
All subjects attended a weekly 1-hour therapy session during the 8 week treatment period.
Other Names:
  • Indivdual Manual-quided relapse prevention therapy
  • or Individual Dug Counseling

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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00015210

Locations
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Boston University
Investigators
Principal Investigator: Dom Ciraulo, M.D. Boston University
  More Information

Publications:
Responsible Party: Dominic Ciraulo, Principal Investigator, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00015210     History of Changes
Other Study ID Numbers: NIDA-5-0013-4, Y01-5-0013-4
Study First Received: April 18, 2001
Last Updated: November 14, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Disease
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes
Nefazodone
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014