Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-30 @ 6:37 AM
Study NCT ID:
NCT00586534
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2007-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing Computer Based Treatments for Addiction
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Developing Computer Based Treatments for Addiction
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DA026454 | NIH | None | https://reporter.nih.gov/quic… | View |