Disulfiram and Cognitive Behavioral Therapy

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.

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 Investigator: Yale University Other

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

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