CBT With Disulfiram and Contingency Management

Cocaine Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350870
• Other study ID #: 0408026992
• Secondary ID: 5R01DA019078
• Status: Completed
• Phase: Phase 1
• First received: July 7, 2006
• Last updated: November 26, 2014
• Start date: April 2005
• Est. completion date: December 2010

Study information

• Verified date: November 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Abuse

Intervention

Drug:
• disulfiram
250mg per day of Disulfiram plus CBT
• Placebo
Placebo plus CBT

Behavioral:
• Placebo plus Contingency Management
Placebo 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.

Locations

Country	Name	City	State
United States	APT Foundation	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No