Applying Web Technology to Buprenorphine Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by National Development and Research Institutes, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier:
NCT00182598
First received: September 10, 2005
Last updated: August 11, 2008
Last verified: August 2008

September 10, 2005
August 11, 2008
December 2004
Not Provided
opiate use
Same as current
Complete list of historical versions of study NCT00182598 on ClinicalTrials.gov Archive Site
  • treatment retention
  • other drug use
  • HIV risk behavior
  • opiate craving
  • psychosocial status
  • feedback on intervention
Same as current
Not Provided
Not Provided
 
Applying Web Technology to Buprenorphine Treatment
Applying Web Technology to Buprenorphine Treatment

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Adult Opioid-Dependence
  • Procedure: computer-based psychoeducational intervention
  • Procedure: community-based substance abuse counseling
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
Not Provided
Not Provided

Inclusion Criteria:

  • Opioid dependence
  • Adults ( >/= 18 years)
  • In first month of office-based buprenorphine maintenance treatment

Exclusion Criteria:

  • In buprenorphine-assisted taper
Both
18 Years and older
No
Contact: Lisa Marsch, PhD 212-845-4655 marsch@ndri.org
Contact: Honoria Guarino, PhD 212-845-4540 guarino@ndri.org
United States
 
NCT00182598
R42 DA14727
Not Provided
Not Provided
National Development and Research Institutes, Inc.
Not Provided
Principal Investigator: Lisa Marsch, PhD National Development and Research Institutes, Inc.
National Development and Research Institutes, Inc.
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP