Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

CBT With Disulfiram and Contingency Management

This study has been completed.
Information provided by (Responsible Party):
Yale University Identifier:
First received: July 7, 2006
Last updated: November 26, 2014
Last verified: November 2014

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
Drug: Placebo
Behavioral: Placebo plus Contingency Management
Drug: Disulfiram plus Contingency Management
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:
  • Change in Cocaine Use by Self Report [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Self-reports of substance use will be documented at each contact via the Substance Use Calendar. Similar to the Form-90 and the Time Line Follow-Back, which have been shown to be reliable and valid instruments for monitoring substance use and other outcomes in longitudinal studies202-204, the Substance Use Calendar allows a flexible, continuous evaluation of substance use on a daily basis.

  • Change in Cocaine Use by Urine Toxicology Results [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    We will use the Roche onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepenes, and opioids.

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: Placebo
Placebo (plus Cognitive Behavioral Therapy- CBT)
Drug: Placebo
Placebo plus CBT
Other Name: placebo
Active Comparator: Disulfiram
Disulfiram (plus CBT)
Drug: disulfiram
250mg per day of Disulfiram plus CBT
Other Names:
  • antabuse
  • antabus
Placebo Comparator: Placebo plus Contingency Management
Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Behavioral: Placebo plus Contingency Management
Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT
Active Comparator: Disulfiram plus Contingency Management
Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Drug: Disulfiram plus Contingency Management
250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT.
Other Names:
  • antabuse
  • antabus

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

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

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 identifier: NCT00350870

United States, Connecticut
APT Foundation
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
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 Identifier (NCT Number):
Responsible Party: Yale University Identifier: NCT00350870     History of Changes
Other Study ID Numbers: 0408026992, 5R01DA019078
Study First Received: July 7, 2006
Results First Received: November 12, 2014
Last Updated: November 26, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Alcohol Deterrents
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on February 27, 2015