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 19, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Cocaine Addiction
Behavioral: I/GDC + VR/CER
Behavioral: I/GDC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Developing Computer Based Treatments for Addiction

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 180
Study Start Date: January 2007
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I/GDC
NIDA approved Individual/Group Drug Counseling (I/GDC) cocaine treatment
Behavioral: I/GDC
NIDA approved Individual/Group Drug Counseling (I/GDC) cocaine treatment
Other Names:
  • drug counseling
  • group drug counseling
  • individual drug counseling
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00586534

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Zachary Rosenthal, PhD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00586534     History of Changes
Other Study ID Numbers: Pro00011048, R01DA026454
Study First Received: December 21, 2007
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
crack, cocaine, addiction treatment, virtual reality

Additional relevant MeSH terms:
Behavior, Addictive
Cocaine-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014