Applying Web Technology to Buprenorphine Treatment
Primary Purpose
Adult Opioid-Dependence
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
computer-based psychoeducational intervention
community-based substance abuse counseling
Sponsored by
About this trial
This is an interventional treatment trial for Adult Opioid-Dependence focused on measuring buprenorphine, computer, treatment, opioid, heroin
Eligibility Criteria
Inclusion Criteria: Opioid dependence Adults ( >/= 18 years) In first month of office-based buprenorphine maintenance treatment Exclusion Criteria: In buprenorphine-assisted taper
Sites / Locations
- Dr. Steven LeeRecruiting
- Dr. Tania TaubesRecruiting
Outcomes
Primary Outcome Measures
opiate use
Secondary Outcome Measures
treatment retention
other drug use
HIV risk behavior
opiate craving
psychosocial status
feedback on intervention
Full Information
NCT ID
NCT00182598
First Posted
September 10, 2005
Last Updated
August 11, 2008
Sponsor
National Development and Research Institutes, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00182598
Brief Title
Applying Web Technology to Buprenorphine Treatment
Official Title
Applying Web Technology to Buprenorphine Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Development and Research Institutes, Inc.
4. Oversight
5. Study Description
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 (e.g., information about buprenorphine, HIV/AIDS 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 physician's 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Opioid-Dependence
Keywords
buprenorphine, computer, treatment, opioid, heroin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
computer-based psychoeducational intervention
Intervention Type
Procedure
Intervention Name(s)
community-based substance abuse counseling
Primary Outcome Measure Information:
Title
opiate use
Secondary Outcome Measure Information:
Title
treatment retention
Title
other drug use
Title
HIV risk behavior
Title
opiate craving
Title
psychosocial status
Title
feedback on intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Opioid dependence
Adults ( >/= 18 years)
In first month of office-based buprenorphine maintenance treatment
Exclusion Criteria:
In buprenorphine-assisted taper
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Marsch, PhD
Phone
212-845-4655
Email
marsch@ndri.org
First Name & Middle Initial & Last Name or Official Title & Degree
Honoria Guarino, PhD
Phone
212-845-4540
Email
guarino@ndri.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Marsch, PhD
Organizational Affiliation
National Development and Research Institutes, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Steven Lee
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Marsch, PhD
Phone
212-845-4655
Email
marsch@ndri.org
First Name & Middle Initial & Last Name & Degree
Honoria Guarino, PhD
Phone
212-845-4540
Email
guarino@ndri.org
First Name & Middle Initial & Last Name & Degree
Lisa Marsch, PhD
Facility Name
Dr. Tania Taubes
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Marsch, PhD
Phone
212-845-4655
Email
marsch@ndri.org
First Name & Middle Initial & Last Name & Degree
Honoria Guarino, PhD
Phone
212-845-4540
Email
guarino@nri.org
First Name & Middle Initial & Last Name & Degree
Lisa Marsch, PhD
12. IPD Sharing Statement
Learn more about this trial
Applying Web Technology to Buprenorphine Treatment
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