NCT01406899

Brief Summary

In this behavioral trial 80 substance abusing individuals will be randomly assigned to either treatment as usual in the substance abuse clinic of the Newington, CT VA hospital 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 substance 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2010

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

Study Start

First participant enrolled

January 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 23, 2014

Status Verified

March 1, 2012

Enrollment Period

3.3 years

First QC Date

July 27, 2011

Last Update Submit

December 22, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reduction in substance use

    percent days abstinent, confirmed by urine toxicology screens

    8 weeks

Secondary Outcomes (1)

  • Retention in treatment

    6 months

Study Arms (2)

Treatment as Usual

NO INTERVENTION

Standard treatment as usual (TAU) in the VA Connecticut Healthcare System substance abuse clinic consisting of individual and group therapy sessions and regular urine monitoring.

Computer-based treatment

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 substance use and increasing coping skills twice weekly for 8 weeks.

Behavioral: Computer Based Treatment

Interventions

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 substance use and increasing coping skills twice weekly for 8 weeks.

Also known as: Cognitive Behavioral Therapy
Computer-based treatment

Eligibility Criteria

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

You may qualify if:

  • years and older
  • Recent (within 3 months) substance use
  • meet current DSM-IV (Diagnostic and Statistical Manual-IV) criteria for substance use disorder
  • fluent in English or at least a 6th grade reading level
  • can commit to at least 8 weeks of treatment and willing to be randomized to treatment

You may not qualify if:

  • Unstable housing situation
  • Likelihood of going to prison during the intervention portion of study
  • Recent opiate or benzodiazepine prescription

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut VA Healthcare System

Newington, Connecticut, 06111, United States

Location

Related Publications (1)

  • Lichenstein SD, Kohler R, Ye F, Potenza MN, Kiluk B, Yip SW. Distinct neural networks predict cocaine versus cannabis treatment outcomes. Mol Psychiatry. 2023 Aug;28(8):3365-3372. doi: 10.1038/s41380-023-02120-0. Epub 2023 Jun 12.

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Kathleen Carroll, Ph.D.

    Yale University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 27, 2011

First Posted

August 1, 2011

Study Start

January 1, 2010

Primary Completion

May 1, 2013

Study Completion

December 1, 2013

Last Updated

December 23, 2014

Record last verified: 2012-03

Locations