Nefazodone in the Treatment of Cocaine Dependence and Depression - 4

Boston Medical Center69 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Interventions

NefazodoneDRUG

Psychosocial TreatmentBEHAVIORAL

All subjects attended a weekly 1-hour therapy session during the 8 week treatment period.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (1)

Boston University

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Urine benzoylecgonine (BE) concentration

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 Outcomes

Hamilton Depression Scale (HAM-D)

HAM-D collected on a weekly basis.

Time frame: Baseline through Study Week 8

Cocaine-Craving Scale

CCS scores were collected on a weekly basis.

Time frame: Baseline through Week 8

Adverse Events Self Report

Data for adverse events were collected on a weekly basis

Time frame: 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.

Time frame: Baseline through Study Week 8

Data from ClinicalTrials.gov

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