Nefazodone in the Treatment of Cocaine Dependence and Depression - 4

July 29, 2015 updated by: Dominic Ciraulo, Boston Medical Center

Efficacy of Nefazodone in Cocaine Dependent Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine benzoylecgonine (BE) concentration
Time Frame: Study Weeks Basekine to Week 8
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)
Time Frame: Baseline through Study Week 8
HAM-D collected on a weekly basis.
Baseline through Study Week 8
Cocaine-Craving Scale
Time Frame: Baseline through Week 8
CCS scores were collected on a weekly basis.
Baseline through Week 8
Adverse Events Self Report
Time Frame: Study Weeks 1 through 8
Data for adverse events were collected on a weekly basis
Study Weeks 1 through 8
Alcohol Drug Use Inventory
Time Frame: Baseline through Study Week 8
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Collaborators

Boston University

Investigators

  • Principal Investigator: Dom Ciraulo, M.D., Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1997

Primary Completion (Actual)

May 1, 1999

Study Registration Dates

First Submitted

April 18, 2001

First Submitted That Met QC Criteria

April 17, 2001

First Posted (Estimate)

April 18, 2001

Study Record Updates

Last Update Posted (Estimate)

July 30, 2015

Last Update Submitted That Met QC Criteria

July 29, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-5-0013-4
  • Y01-5-0013-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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