Nefazodone in the Treatment of Cocaine Dependence and Depression - 4

Boston Medical Center (BMC)

Status and phase: Completed; Phase 2

Conditions: Substance-Related Disorders; Cocaine-Related Disorders

Treatments: Behavioral: Psychosocial Treatment; Drug: Nefazodone

Study type: Interventional

Funder types: Other

Identifiers

NCT00015210

NIDA-5-0013-4

Y01-5-0013-4

Details and patient eligibility

About

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

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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69 participants in 2 patient groups, including a placebo group

Nefazodone

Active Comparator group

Description:

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.

Treatment:

Drug: Nefazodone

Behavioral: Psychosocial Treatment

Matched Placebo Tablet

Placebo Comparator group

Description:

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.

Treatment:

Drug: Nefazodone

Behavioral: Psychosocial Treatment