NCT00350610

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2006

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

5.1 years

First QC Date

July 7, 2006

Last Update Submit

January 28, 2013

Conditions

Cocaine Abuse

Keywords

cognitive behavior therapycomputer assisted instructiondrug abuse therapyeducational resource design and development

Outcome Measures

Primary Outcomes (1)

  • reduction in drug use

    8 weeks

Secondary Outcomes (2)

  • patients ability to demonstrate coping skills through a computerized role-playing evaluation

    8 weeks

  • retention in treatment

    8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Standard treatment as usual (TAU) in a community based clinic consisting of individual and group therapy sessions and regular urine monitoring.

Other: Treatment as usual (TAU)

2

EXPERIMENTAL

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.

Other: Treatment as usual (TAU)Behavioral: CBT for CBT

Interventions

Treatment as usual (TAU)OTHER

Standard treatment as usual in a community based treatment setting

12
CBT for CBTBEHAVIORAL

Standard treatment as usual (TAU) plus computer based therapy using CBT

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APT Foundation Orchard Hill Clinic

New Haven, Connecticut, 06516, United States

Location

Related Publications (6)

  • DeVito EE, Kober H, Carroll KM, Potenza MN. fMRI Stroop and behavioral treatment for cocaine-dependence: Preliminary findings in methadone-maintained individuals. Addict Behav. 2019 Feb;89:10-14. doi: 10.1016/j.addbeh.2018.09.005. Epub 2018 Sep 6.

    PMID: 30240978DERIVED

  • Decker SE, Morie K, Hunkele K, Babuscio T, Carroll KM. Emotion regulation strategies in individuals with cocaine use disorder maintained on methadone. Am J Addict. 2016 Oct;25(7):529-32. doi: 10.1111/ajad.12439. Epub 2016 Sep 22.

    PMID: 27658192DERIVED

  • Morie KP, Nich C, Hunkele K, Potenza MN, Carroll KM. Alexithymia level and response to computer-based training in cognitive behavioral therapy among cocaine-dependent methadone maintained individuals. Drug Alcohol Depend. 2015 Jul 1;152:157-63. doi: 10.1016/j.drugalcdep.2015.04.004. Epub 2015 Apr 27.

    PMID: 25982006DERIVED

  • Carroll KM, Kiluk BD, Nich C, Gordon MA, Portnoy GA, Marino DR, Ball SA. Computer-assisted delivery of cognitive-behavioral therapy: efficacy and durability of CBT4CBT among cocaine-dependent individuals maintained on methadone. Am J Psychiatry. 2014 Apr;171(4):436-44. doi: 10.1176/appi.ajp.2013.13070987.

    PMID: 24577287DERIVED

  • Worhunsky PD, Stevens MC, Carroll KM, Rounsaville BJ, Calhoun VD, Pearlson GD, Potenza MN. Functional brain networks associated with cognitive control, cocaine dependence, and treatment outcome. Psychol Addict Behav. 2013 Jun;27(2):477-88. doi: 10.1037/a0029092. Epub 2012 Jul 9.

    PMID: 22775772DERIVED

  • Carroll KM, Kiluk BD, Nich C, Babuscio TA, Brewer JA, Potenza MN, Ball SA, Martino S, Rounsaville BJ, Lejuez CW. Cognitive function and treatment response in a randomized clinical trial of computer-based training in cognitive-behavioral therapy. Subst Use Misuse. 2011;46(1):23-34. doi: 10.3109/10826084.2011.521069.

    PMID: 21190403DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Kathleen Carroll, PhD

    Yale University/Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2006

First Posted

July 11, 2006

Study Start

November 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

US(1)