Disulfiram and Cognitive Behavioral Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00350870
First received: July 7, 2006
Last updated: February 17, 2012
Last verified: February 2012
  Purpose

This is a study of four treatments for chronic cocaine use and may help study participants to control their drug use. All participants will receive weekly individual cognitive behavioral therapy (CBT).


Condition Intervention Phase
Cocaine Abuse
Drug: disulfiram
Behavioral: Placebo
Behavioral: Placebo plus CM
Drug: Disulfiram plus CM
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Maximizing the Efficacy of Cognitive Behavioral Therapy With Medication and Contingency Management

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Reduction in cocaine use by self report and urine toxicology results [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurocognitive functioning [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 181
Study Start Date: April 2005
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo plus CBT
Behavioral: Placebo
Placebo plus CBT
Active Comparator: 2
Disulfiram plus CBT
Drug: disulfiram
250mg per day of Disulfiram plus CBT
Placebo Comparator: 3
Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT.
Behavioral: Placebo plus CM
Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT
Active Comparator: 4
Disulfiram plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT.
Drug: Disulfiram plus CM
250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT.

Detailed Description:

This study will compare four types of treatment involving skills training and incentives for attending sessions or taking study medication. Disulfiram is a widely prescribed deterrent to alcohol use. In addition to weekly cognitive behavioral therapy (CBT), participants will be assigned to one of the following treatments:

  1. placebo
  2. disulfiram
  3. placebo plus incentives for cocaine abstinence and medication compliance (prize CM)
  4. disulfiram plus incentives for cocaine abstinence and medication compliance
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-50 year old
  • cocaine dependent
  • willing to sign consent
  • willing to accept randomization to intervention

Exclusion Criteria:

  • significant medical conditions
  • psychiatric disorder with current use of prescribed psychotropic medication
  • lifetime schizophrenia or bipolar disorder
  • suicidality or homicidality
  • unlikely to be able to complete 1 year follow up
  • unable to speak or read English at a third grade level
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350870

Locations
United States, Connecticut
APT Foundation
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Kathleen M. Carroll, PhD Yale School of Medicine
  More Information

No publications provided by Yale University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00350870     History of Changes
Other Study ID Numbers: 0408026992, 5R01DA019078
Study First Received: July 7, 2006
Last Updated: February 17, 2012
Health Authority: United States: Federal Government

Keywords provided by Yale University:
disulfiram
cognitive behavioral therapy
contingency management
drug abuse therapy
educational/resource design/development

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Disulfiram
Alcohol Deterrents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014