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Clinical Trials/NCT00350870
NCT00350870
Completed
Phase 1

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

Yale University1 site in 1 country181 target enrollmentApril 2005

Overview

Phase
Phase 1
Intervention
Placebo
Conditions
Cocaine Abuse
Sponsor
Yale University
Enrollment
181
Locations
1
Primary Endpoint
Change in Cocaine Use by Self Report
Status
Completed
Last Updated
11 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 2005
End Date
December 2010
Last Updated
11 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Placebo

Placebo (plus Cognitive Behavioral Therapy- CBT)

Intervention: Placebo

Disulfiram

Disulfiram (plus CBT)

Intervention: disulfiram

Placebo plus Contingency Management

Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).

Intervention: Placebo plus Contingency Management

Disulfiram plus Contingency Management

Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).

Intervention: Disulfiram plus Contingency Management

Outcomes

Primary Outcomes

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.

Study Sites (1)

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