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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00350610
Other study ID # 0207017894
Secondary ID DA015969
Status Completed
Phase Phase 1
First received July 7, 2006
Last updated January 28, 2013
Start date November 2007
Est. completion date December 2012

Study information

Verified date January 2013
Source Yale University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States APT Foundation Orchard Hill Clinic 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 reduction in drug use 8 weeks No
Secondary patients ability to demonstrate coping skills through a computerized role-playing evaluation 8 weeks No
Secondary retention in treatment 8 weeks No
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