Developing Computer Based Treatments for Addiction
Condition: Cocaine Addiction
MeSH terms: Cocaine-Related Disorders; Behavior, Addictive
Study type: Interventional

Summary: 
      The purpose of our research is to examine the promise of a new computer based approach to use
      in usual drug counseling when treating crack cocaine addiction.
    

Detailed description: 
      This is the next part of the project under a National Institute of Drug Abuse-funded R01
      treatment development study with the purpose of developing a computer-based augmentation of
      standard drug counseling for cocaine dependence. This project has received additional funding
      from NIDA. Specifically, the aims of the next part of the proposal are to develop and
      manualize a cue-exposure based cocaine treatment using virtual reality (VR) based cue
      exposure/extinction software and cellular phone-based computerized extinction reminder (CER)
      technology for use in high-risk situations outside treatment sessions. We will enroll a total
      of 270 cocaine dependent subjects in order to meet the target goal of 180 subjects in
      treatment. This randomized clinical trial will be conducted in order to determine the
      acceptability and feasibility of this treatment to subjects and therapists, and to obtain
      treatment outcome effect size estimates. Specifically, during the next stage of the study,
      180 cocaine dependent individuals will be randomly assigned to receive a NIDA approved
      Individual/Group Drug Counseling (I/GDC) cocaine treatment or I/GDC plus VR/CER. Matching
      between treatment groups will be based on age, sex, severity of crack use (using the
      Addiction Severity Index), and presence or absence of antisocial personality disorder.
      Treatment assignment will be conducted using a computerized urn matching program by the
      off-site study statistician. Current psychiatric diagnoses will be assessed, as will changes
      in crack use. Comprehensive assessments will be conducted during treatment at baseline, and
      at a six-month and twelve-month follow-up. To measure outcomes, substance use will be
      assessed via self-report and urinary analysis three times weekly during 24 weeks of active
      treatment and weekly during six month and twelve month of follow-up assessment.

      This new larger part of project follows work we have conducted in a NIDA-funded pilot project
      over the past four years, developing the complementary intervention. In our preliminary
      studies (Phase I a/b), we conducted focus groups, an open trial, and a small randomized
      controlled trial (n = 53) to demonstrate the promise of the novel intervention. The pilot
      phase I a/b portion enrolled 171 subjects (signed consent) at Duke. 19 of 53 completed the
      treatment portion. During Phase 1a, the VR and CER technology was developed and refined using
      two small open clinical trials. At the conclusion of Phase 1a, a treatment manual detailing
      the rationale and parameters of VR and CER technology was completed. Next, as mentioned, a
      Phase Ib pilot randomized clinical trial was conducted in order to determine the
      acceptability and feasibility of this treatment to patients and therapists, and to obtain
      treatment outcome effect size estimates.
    

Intervention name(s): I/GDC + VR/CER; I/GDC
Intervention type(s): Behavioral; Behavioral
Intervention description(s): NIDA approved Individual/Group Drug Counseling (I/GDC) cocaine treatment plus virtual reality (VR) based cue exposure/extinction software and cellular phone-based computerized extinction reminder (CER) technology for use in high-risk situations outside treatment sessions.; NIDA approved Individual/Group Drug Counseling (I/GDC) cocaine treatment
Other intervention name(s): drug counseling; group drug counseling; individual drug counseling; virtual reality; exposure/extinction software; cellular phone based computerized extinction reminder; drug counseling; group drug counseling; individual drug counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: crack, cocaine, addiction treatment, virtual reality