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Completed

NCT Number: NCT00015210

Nefazodone in the Treatment of Cocaine Dependence and Depression - 4

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

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Key information

Conditions

Cocaine-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Boston University

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nefazodone

Drug

Other names: Serzone

Psychosocial treatment

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Hamilton Depression Scale (HAM-D)

    Time frame: Baseline through Study Week 8

    HAM-D collected on a weekly basis.

  2. Cocaine-Craving Scale

    Time frame: Baseline through Week 8

    CCS scores were collected on a weekly basis.

  3. Adverse Events Self Report

    Time frame: Study Weeks 1 through 8

    Data for adverse events were collected on a weekly basis

  4. 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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Boston University

Registry information

Official study title

Efficacy of Nefazodone in Cocaine Dependent Subjects

Important dates

Study start
1997
Primary completion
1999
First posted
Apr 18, 2001
Registry last updated
Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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