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CBT With Disulfiram and Contingency Management

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ClinicalTrials.gov Identifier: NCT00350870
Recruitment Status : Completed
First Posted : July 11, 2006
Results First Posted : December 3, 2014
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Brief Summary:
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 or disease Intervention/treatment Phase
Cocaine Abuse Drug: disulfiram Drug: Placebo Behavioral: Placebo plus Contingency Management Drug: Disulfiram plus Contingency Management Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Maximizing the Efficacy of Cognitive Behavioral Therapy With Medication and Contingency Management
Study Start Date : April 2005
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Disulfiram

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo (plus Cognitive Behavioral Therapy- CBT)
Drug: Placebo
Placebo plus CBT

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




Primary Outcome Measures :
  1. Change in Cocaine Use by Self Report [ Time Frame: 12 weeks ]
    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.

  2. Change in Cocaine Use by Urine Toxicology Results [ Time Frame: 12 weeks ]
    We will use the Roche onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepenes, and opioids.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350870


Locations
United States, Connecticut
APT Foundation
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Kathleen M. Carroll, PhD Yale School of Medicine

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 ( U.S. NIH Grant/Contract )
First Posted: July 11, 2006    Key Record Dates
Results First Posted: December 3, 2014
Last Update Posted: December 3, 2014
Last Verified: November 2014

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
Cocaine
Disulfiram
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Alcohol Deterrents
Acetaldehyde Dehydrogenase Inhibitors
Enzyme Inhibitors