CBT With Disulfiram and Contingency Management

Phase 1

Completed

• Conditions: Cocaine Abuse
• Interventions: Drug: Placebo; Behavioral: Placebo plus Contingency Management; Drug: Disulfiram plus Contingency Management; Drug: disulfiram

• Registration Number: NCT00350870
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2005-04
• Study First Submitted: 2006-07-07
• Study First Submitted QC: 2006-07-07
• Study First Posted: 2006-07-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2014-11
• Results First Submitted: 2014-11-12
• Results First Submitted QC: 2014-11-26
• Last Update Submitted: 2014-11-26
• Results First Posted: 2014-12-03
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

Inclusion Criteria

• 18-50 year old
• cocaine dependent
• willing to sign consent
• willing to accept randomization to intervention

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo (plus Cognitive Behavioral Therapy- CBT)
Placebo plus Contingency Management	Placebo plus Contingency Management	Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Disulfiram plus Contingency Management	Disulfiram plus Contingency Management	Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Disulfiram	disulfiram	Disulfiram (plus CBT)

Primary Outcome Measures

Name	Time	Method
Change in Cocaine Use by Self Report	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	12 weeks	We will use the Roche onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepenes, and opioids.

Trial Locations

Locations (1)

APT Foundation; 🇺🇸 New Haven, Connecticut, United States