Developing Computer Based Treatments for 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.

Inclusion Criteria:

- Meets SCID-I criteria for cocaine dependence; crack cocaine is primary substance of
abuse

- Consents to outpatient treatment for drug addiction.

Exclusion Criteria:

- Full criteria met for psychosis

- 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