CBT With Disulfiram and Contingency Management

Study Overview
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Brief Summary
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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
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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

Official Title
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Maximizing the Efficacy of Cognitive Behavioral Therapy With Medication and Contingency Management

Conditions
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Cocaine Abuse

Intervention / Treatment
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* Drug: disulfiram
* Drug: Placebo
* Behavioral: Placebo plus Contingency Management
* Drug: Disulfiram plus Contingency Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo (plus Cognitive Behavioral Therapy- CBT) | Drug: Placebo<br>* Placebo plus CBT<br>|
| Active Comparator: Disulfiram<br>Disulfiram (plus CBT) | Drug: disulfiram<br>* 250mg per day of Disulfiram plus CBT<br>* Other names: antabus;|
| Placebo Comparator: Placebo plus Contingency Management<br>Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT). | Behavioral: Placebo plus Contingency Management<br>* Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT<br>|
| Active Comparator: Disulfiram plus Contingency Management<br>Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT). | Drug: Disulfiram plus Contingency Management<br>* 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT.<br>* Other names: antabus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disulfiram, cognitive behavioral therapy, contingency management, drug abuse therapy, educational/resource design/development