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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Factorial Assignment, Efficacy Study

Study Primary Completion Date: February 2009

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, 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

Intervention(s) in this Clinical Trial

• Drug: disulfiram
  • 250mg per day of Disulfiram plus CBT
• Behavioral: Placebo
  • Placebo plus CBT
• Behavioral: Placebo plus CM
  • Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT
• Drug: Disulfiram plus CM
  • 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Placebo plus CBT
• Active Comparator: 2
  • Disulfiram plus CBT
• Placebo Comparator: 3
  • Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT.
• Active Comparator: 4
  • Disulfiram plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT.

Primary Measures

• Reduction in cocaine use by self report and urine toxicology results
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Neurocognitive functioning
  • Time Frame: 12 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Kathleen M. Carroll, PhD Principal Investigator Yale School of Medicine  

Overall Contact: Dorothy Eagan, RN, MPH 203-781-0282 deagan@aptfoundation.org

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00350870

Study ID Number: 0408026992

ClinicalTrials.gov Identifier: NCT00350870

Health Authority: United States: Federal Government