Nefazodone in the Treatment of Cocaine Dependence and Depression - 4

Phase 2

Completed

• Conditions: Cocaine-Related Disorders; Substance-Related Disorders
• Interventions: Drug: Nefazodone; Behavioral: Psychosocial Treatment

• Registration Number: NCT00015210
• Lead Sponsor: Boston Medical Center

Brief Summary

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

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 Timeline

• Study Start: 1997-02
• Primary Completion: 1999-05
• Study First Submitted QC: 2001-04-17
• Study First Submitted: 2001-04-18
• Study First Posted: 2001-04-18
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nefazodone	Psychosocial Treatment	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.
Matched Placebo Tablet	Psychosocial Treatment	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.
Nefazodone	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.
Matched Placebo Tablet	Nefazodone	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.

Primary Outcome Measures

Name	Time	Method
Urine benzoylecgonine (BE) concentration	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 Outcome Measures

Name	Time	Method
Alcohol Drug Use Inventory	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.
Hamilton Depression Scale (HAM-D)	Baseline through Study Week 8	HAM-D collected on a weekly basis.
Cocaine-Craving Scale	Baseline through Week 8	CCS scores were collected on a weekly basis.
Adverse Events Self Report	Study Weeks 1 through 8	Data for adverse events were collected on a weekly basis

Trial Locations

Locations (1)

Boston University; 🇺🇸 Boston, Massachusetts, United States