Nefazodone in the Treatment of Cocaine Dependence and Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-02-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cocaine-Related Disorders Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Nefazodone

Intervention Type DRUG

Psychosocial Treatment

Intervention Type BEHAVIORAL

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

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.

Group Type PLACEBO_COMPARATOR

Nefazodone

Intervention Type DRUG

Psychosocial Treatment

Intervention Type BEHAVIORAL

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

Interventions

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Nefazodone

Intervention Type DRUG

Psychosocial Treatment

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Serzone Indivdual Manual-quided relapse prevention therapy or Individual Dug Counseling

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No