Developing Computer Based Treatments for Addiction

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00586534
First received: December 21, 2007
Last updated: August 6, 2013
Last verified: August 2013

December 21, 2007
August 6, 2013
January 2007
July 2014   (final data collection date for primary outcome measure)
Urinalyses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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
Urinalyses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00586534 on ClinicalTrials.gov Archive Site
  • Physiological measures: skin conductance, heart rate, and skin temperature [ Time Frame: Intake, 6 month, 9 month, and 12 month follow-up assessments ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • HIV Risk Behaviors [ Time Frame: 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
    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.
  • Physiological measures: skin conductance, heart rate, and skin temperature [ Time Frame: Intake, 6 month, 9 month, and 12 month follow-up assessments ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Self-report measures of Substance use (e.g., TLFB) [ Time Frame: Intake assessment, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • HIV Risk Behaviors [ Time Frame: 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Developing Computer Based Treatments for Addiction
Developing Computer Based Treatments for Addiction

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Cocaine Addiction
  • Behavioral: I/GDC + VR/CER
    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.
    Other Names:
    • drug counseling
    • group drug counseling
    • individual drug counseling
    • virtual reality
    • exposure/extinction software
    • cellular phone based computerized extinction reminder
  • Behavioral: I/GDC
    NIDA approved Individual/Group Drug Counseling (I/GDC) cocaine treatment
    Other Names:
    • drug counseling
    • group drug counseling
    • individual drug counseling
  • Active Comparator: I/GDC
    NIDA approved Individual/Group Drug Counseling (I/GDC) cocaine treatment
    Intervention: Behavioral: I/GDC
  • Experimental: I/GDC + VR/CER
    Second Arm: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.
    Intervention: Behavioral: I/GDC + VR/CER
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
180
October 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meets SCID-I criteria for cocaine dependence; crack cocaine is primary substance of abuse
  • Consents to outpatient treatment for drug addiction
  • Resides within commuting distance of treatment

Exclusion Criteria:

  • Full criteria met for psychotic disorders
  • Full criteria met for current mania
  • IQ less than 70
  • Unable to give consent
  • Can not read
  • Current and chronic absence of shelter
  • Impending jail/prison for more than three weeks (problems which by their presence or severity preclude ability to attend or understand treatment and/or requires priority treatment over substance use treatment)
  • Court order to treatment or to jail, or agency order to treatment or loss of child custody (due to inability to freely drop-out of treatment)
  • Refuses to discontinue current drug abuse treatment or refuses random assignment
  • If the potential participant lives with or is in an intimate relationship with another participant currently being treated in the study, they will be told that they cannot participate until that housemate or partner has completed treatment in the study
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00586534
Pro00011048, R01DA026454
Yes
Duke University
Duke University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Zachary Rosenthal, PhD Duke University
Duke University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP