Clinical Trial: Developing Computer Based Treatments for Addiction

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Developing Computer Based Treatments for Addiction

Brief 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 Summary:

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 follow
Sponsor: Duke University

Current Primary Outcome: Urinalyses [ Time Frame: 1 year ]

urinary analysis will be conducted three times weekly during 24 weeks of active treatment. During the booster phase (months 7-9), UA's will occur once monthly, before the booster sessions and again at 12 months. Urine will be tested for cocaine, marijuana, opiates, amphetamines, and benzodiazepines


Original Primary Outcome: Urinalyses [ Time Frame: 1 year ]

Current Secondary Outcome:

  • Physiological measures: skin conductance, heart rate, and skin temperature [ Time Frame: Intake, 6 month, 9 month, and 12 month follow-up assessments ]
    They will be measured using Ag-AgCl electrodes. They will be measured during a 5 minute videotape showing cocaine paraphernalia and use.
  • Interview measures: Structured Clinical Interview for DSM-IV, Axis I (SCID-I), Addiction Severity Index [ Time Frame: Intake, 6 month, 9 month, and 12 month assessments. ]
  • Self-report measures of Substance use [e.g., TLFB; Minnesota Cocaine Craving Questionnaire (MCCS); Cocaine Craving Questionnaire (CCQ)] [ Time Frame: Intake assessment, 6 months, 9months, 12 months ]
  • HIV Risk Behaviors [ Time Frame: 6 months, 9 months, 12 months ]
    The 11-item HIV Risk Behavior Scale (a brief self-report measure using a 6-point Likert-type scale, will be utilized at each time point.


Original Secondary Outcome:

  • Physiological measures: skin conductance, heart rate, and skin temperature [ Time Frame: Intake, 6 month, 9 month, and 12 month follow-up assessments ]
  • Interview measures: Structured Clinical Interview for DSM-IV, Axis I (SCID-I), Addiction Severity Index [ Time Frame: Intake, 6 month, 9 month, and 12 month assessments. ]
  • Self-report measures of Substance use (e.g., TLFB) [ Time Frame: Intake assessment, 6 months, 9months, 12 months ]
  • HIV Risk Behaviors [ Time Frame: 6 months, 9 months, 12 months ]


Information By: Duke University

Dates:
Date Received: December 21, 2007
Date Started: January 2007
Date Completion:
Last Updated: March 17, 2015
Last Verified: March 2015