Official Title: “Computer-Based Training in Cognitive Behavior Therapy”

The computer-based training program (CBT for CBT) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving substance abuse treatment.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2009

In this behavioral trial 120 methadone maintained cocaine abusing individuals will be randomly assigned to either treatment as usual in a community-based clinic OR treatment as usual plus 8 hours of access to the 'CBT for CBT' computer program over a period of 8 weeks.

Primary outcomes will be retention in treatment and reduction in cocaine use (percent days abstinent, confirmed by urine toxicology screens). The patients' ability to demonstrate coping skills through a computerized role-play evaluation will be a secondary outcome. A six-month follow-up will assess durability and/or delayed emergence of effects.

Intervention(s) in this Clinical Trial

• Other: Treatment as usual (TAU)
  • Standard treatment as usual in a community based treatment setting
• Behavioral: CBT for CBT
  • Standard treatment as usual (TAU) plus computer based therapy using CBT

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: 1
  • Standard treatment as usual (TAU) in a community based clinic consisting of individual and group therapy sessions and regular urine monitoring.
• Experimental: 2
  • Standard treatment as usual (TAU) plus coping skills computer program. In addition to the individual and group therapy sessions (TAU), individuals will work with a computerized program that teaches skills for stopping cocaine use and increasing coping skills twice weekly for 8 weeks.

Primary Measures

• reduction in drug use
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• patients ability to demonstrate coping skills through a computerized role-playing evaluation
  • Time Frame: 8 weeks
    Safety Issue?: No
• retention in treatment
  • Time Frame: 8 weeks
    Safety Issue?: No

Inclusion Criteria:

• 18 years and older
• methadone maintained for at least 3 months
• meet current DSM-IV criteria for cocaine use disorder
• fluent in English or at least a6th grade reading level
• can commit to at least 8 weeks of treatment and willing to be randomized to treatment

Exclusion Criteria:

• untreated bipolar or schizophrenic disorder
• current legal case pending (pending incarceration during 8 weeks of study)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

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 Carroll, PhD Principal Investigator Yale University/Department of Psychiatry  

Overall Contact: Galina Portnoy, BA 203-581-0265 gportnoy@abhct.com

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00350610

Study ID Number: DA015969

ClinicalTrials.gov Identifier: NCT00350610

Health Authority: United States: Federal Government