Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182598
Status:
UNKNOWN
Last Update Posted:
2008-08-13
First Post:
2005-09-10
Brief Title:
Applying Web Technology to Buprenorphine Treatment
Sponsor:
National Development and Research Institutes Inc
Organization:
National Development and Research Institutes Inc
Study Overview
Official Title:
Applying Web Technology to Buprenorphine Treatment
Status:
UNKNOWN
Status Verified Date:
2008-08
Last Known Status:
RECRUITING
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 this clinical trial is to examine the efficacy and cost-effectiveness of an interactive computer-based psychoeducational system when used by opioid-dependent patients in office-based buprenorphine treatment
Detailed Description:
The partial opioid agonist buprenorphine was recently approved by the FDA for the treatment of opioid-dependence and will be available via physician prescription enabling a greatly needed expansion of access to opioid treatment services However physicians because of considerable demands on their time will likely be unable to provide or coordinate referral for opioid-dependent patients to receive supplemental educational interventions that are critical to the success of their treatment To address this challenge we are developing an interactive web-based patient education system for opioid-dependent individuals in office-based buprenorphine treatment In this system we plan to provide patients with educational interventions of demonstrated efficacy eg information about buprenorphine HIVAIDS education relapse prevention skills training In Phase I we demonstrated the scientific technical and commercial merit and feasibility of this web-based patient education system by developing several modules of the program as well as the appropriate technology for the program to be delivered in an office-based setting We subsequently assessed these modules in the context of feedback sessions conducted with opioid-dependent individuals in a lab designed to mimic the technical constraints of a physicians office Results demonstrated that this system represents a viable approach to patient education in office-based buprenorphine treatment During Phase II we plan to complete our research and development efforts on this project We will complete all educational modules of the system We will also develop a customization program that patients can use to help them identify the optimal order in which they may access the program modules while in treatment Additionally we will establish an electronic reporting system that will provide physicians prescribing buprenorphine with patient activity reports enabling them to track and document patient progress through the system and ensure that patients are compliant with ancillary educational interventions Additionally we plan to conduct a randomized controlled trial to evaluate the efficacy and cost-effectiveness of this patient education system delivered via the Internet compared to the delivery of patient educational services by community-based treatment facilities outside of the office-based setting This system will provide patients physicians and the larger community with assurance that patients in office-based buprenorphine treatment are receiving ancillary services along with their medication thereby improving their likelihood for a successful treatment outcome
Study Oversight
Has Oversight DMC:
None
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?:
None