Nefazodone in the Treatment of Cocaine Dependence and Depression - 4

NCT00015210 | Completed Phase 2

• 2 other identifiers: NIDA-5-0013-4Y01-5-0013-4
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cocaine-Related Disorders; Substance-Related Disorders

Keywords

Cocaine Use Disorders Dependence Depression

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Hamilton Depression Scale (HAM-D)

  Baseline through Study Week 8

• Cocaine-Craving Scale

  Baseline through Week 8

• Adverse Events Self Report

  Study Weeks 1 through 8

• Alcohol Drug Use Inventory

  Baseline through Study Week 8

Study Arms (2)

Nefazodone

ACTIVE COMPARATOR

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.

Drug: Nefazodone; Behavioral: Psychosocial Treatment

Matched Placebo Tablet

PLACEBO COMPARATOR

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.

Drug: Nefazodone; Behavioral: Psychosocial Treatment

Interventions

Nefazodone DRUG

Also known as: Serzone

Matched Placebo Tablet; Nefazodone

Psychosocial Treatment BEHAVIORAL

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

Also known as: Indivdual Manual-quided relapse prevention therapy, or Individual Dug Counseling

Matched Placebo Tablet; Nefazodone

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: lead
• Boston University: collaborator

Study Sites (1)

Boston University

Boston, Massachusetts, 02118, United States

Location

Related 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. doi: 10.1111/j.1360-0443.2005.00984.x.

  PMID: 15730347 BACKGROUND

MeSH Terms

Conditions

Cocaine-Related Disorders; Substance-Related Disorders

Interventions

nefazodone

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Dom Ciraulo, M.D.

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2001
• First Posted: April 18, 2001
• Study Start: February 1, 1997
• Primary Completion: May 1, 1999
• Last Updated: July 30, 2015

Record last verified: 2015-07

Locations

US (1)