Clinical trial NCT00586534: Developing Computer Based Treatments for Addiction
Official title: Developing Computer Based Treatments for Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Addiction
Keywords: crack, cocaine, addiction treatment, virtual reality
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-01-04
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Urinalyses
timeFrame: 1 year
Secondary outcomes:
measure: Physiological measures: skin conductance, heart rate, and skin temperature
timeFrame: Intake, 6 month, 9 month, and 12 month follow-up assessments
measure: Interview measures: Structured Clinical Interview for DSM-IV, Axis I (SCID-I), Addiction Severity Index
timeFrame: Intake, 6 month, 9 month, and 12 month assessments.
measure: Self-report measures of Substance use [e.g., TLFB; Minnesota Cocaine Craving Questionnaire (MCCS); Cocaine Craving Questionnaire (CCQ)]
timeFrame: Intake assessment, 6 months, 9months, 12 months
measure: HIV Risk Behaviors
timeFrame: 6 months, 9 months, 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Zachary Rosenthal, PhD
role: PRINCIPAL_INVESTIGATOR
References: