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
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Abuse||Drug: disulfiram Drug: Placebo Behavioral: Placebo plus Contingency Management Drug: Disulfiram plus Contingency Management||Phase 1|
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 plus incentives for cocaine abstinence and medication compliance (prize CM)
- disulfiram plus incentives for cocaine abstinence and medication compliance
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||181 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Placebo Comparator: Placebo
Placebo (plus Cognitive Behavioral Therapy- CBT)
Placebo plus CBT
Active Comparator: Disulfiram
Disulfiram (plus CBT)
250mg per day of Disulfiram plus CBT
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.
- 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.
- 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.
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
|United States, Connecticut|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Kathleen M. Carroll, PhD||Yale School of Medicine|