Back to resultsCBT With Disulfiram and Contingency Management
Primary Purpose
Cocaine Abuse
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
disulfiram
Placebo
Placebo plus Contingency Management
Disulfiram plus Contingency Management
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine Abuse focused on measuring disulfiram, cognitive behavioral therapy, contingency management, drug abuse therapy, educational/resource design/development
Eligibility 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
Sites / Locations
- APT Foundation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Placebo
Disulfiram
Placebo plus Contingency Management
Disulfiram plus Contingency Management
Arm Description
Placebo (plus Cognitive Behavioral Therapy- CBT)
Disulfiram (plus CBT)
Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Outcomes
Primary Outcome Measures
Change in Cocaine Use by Self Report
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
We will use the Roche onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepenes, and opioids.
Secondary Outcome Measures
Full Information
NCT ID
NCT00350870
First Posted
July 7, 2006
Last Updated
November 26, 2014
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00350870
Brief Title
CBT With Disulfiram and Contingency Management
Official Title
Maximizing the Efficacy of Cognitive Behavioral Therapy With Medication and Contingency Management
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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:
placebo
disulfiram
placebo plus incentives for cocaine abstinence and medication compliance (prize CM)
disulfiram plus incentives for cocaine abstinence and medication compliance
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Abuse
Keywords
disulfiram, cognitive behavioral therapy, contingency management, drug abuse therapy, educational/resource design/development
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
181 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (plus Cognitive Behavioral Therapy- CBT)
Arm Title
Disulfiram
Arm Type
Active Comparator
Arm Description
Disulfiram (plus CBT)
Arm Title
Placebo plus Contingency Management
Arm Type
Placebo Comparator
Arm Description
Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Arm Title
Disulfiram plus Contingency Management
Arm Type
Active Comparator
Arm Description
Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Intervention Type
Drug
Intervention Name(s)
disulfiram
Other Intervention Name(s)
antabuse, antabus
Intervention Description
250mg per day of Disulfiram plus CBT
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo plus CBT
Intervention Type
Behavioral
Intervention Name(s)
Placebo plus Contingency Management
Intervention Description
Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT
Intervention Type
Drug
Intervention Name(s)
Disulfiram plus Contingency Management
Other Intervention Name(s)
antabuse, antabus
Intervention Description
250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT.
Primary Outcome Measure Information:
Title
Change in Cocaine Use by Self Report
Description
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.
Time Frame
12 weeks
Title
Change in Cocaine Use by Urine Toxicology Results
Description
We will use the Roche onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepenes, and opioids.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen M. Carroll, PhD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
APT Foundation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22775772
Citation
Worhunsky PD, Stevens MC, Carroll KM, Rounsaville BJ, Calhoun VD, Pearlson GD, Potenza MN. Functional brain networks associated with cognitive control, cocaine dependence, and treatment outcome. Psychol Addict Behav. 2013 Jun;27(2):477-88. doi: 10.1037/a0029092. Epub 2012 Jul 9.
Results Reference
derived
PubMed Identifier
22695473
Citation
Carroll KM, Nich C, Shi JM, Eagan D, Ball SA. Efficacy of disulfiram and Twelve Step Facilitation in cocaine-dependent individuals maintained on methadone: a randomized placebo-controlled trial. Drug Alcohol Depend. 2012 Nov 1;126(1-2):224-31. doi: 10.1016/j.drugalcdep.2012.05.019. Epub 2012 Jun 12.
Results Reference
derived
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CBT With Disulfiram and Contingency Management
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