Nefazodone in the Treatment of Cocaine Dependence and Depression - 4

Substance-Related Disorders Clinical Trial

Official title:

Efficacy of Nefazodone in Cocaine Dependent Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00015210
• Other study ID #: NIDA-5-0013-4
• Secondary ID: Y01-5-0013-4
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2001
• Last updated: July 29, 2015
• Start date: February 1997

Study information

• Verified date: July 2015
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. primary completion date: May 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders
• Disease
• Substance-Related Disorders

Intervention

Drug:
• Nefazodone

Behavioral:
• Psychosocial Treatment
All subjects attended a weekly 1-hour therapy session during the 8 week treatment period.

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Boston University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ciraulo DA, Knapp C, Rotrosen J, Sarid-Segal O, Ciraulo AM, LoCastro J, Greenblatt DJ, Leiderman D. Nefazodone treatment of cocaine dependence with comorbid depressive symptoms. Addiction. 2005 Mar;100 Suppl 1:23-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine benzoylecgonine (BE) concentration	Natural log BE in urine samples collected weekly were analyzed for the baseline week and the subsequent 8 treatment weeks.	Study Weeks Basekine to Week 8	No
Secondary	Hamilton Depression Scale (HAM-D)	HAM-D collected on a weekly basis.	Baseline through Study Week 8	No
Secondary	Cocaine-Craving Scale	CCS scores were collected on a weekly basis.	Baseline through Week 8	No
Secondary	Adverse Events Self Report	Data for adverse events were collected on a weekly basis	Study Weeks 1 through 8	Yes
Secondary	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.	Baseline through Study Week 8	Yes