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
  Purpose

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.


Condition Intervention
Adult Opioid-Dependence
Procedure: computer-based psychoeducational intervention
Procedure: community-based substance abuse counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Applying Web Technology to Buprenorphine Treatment

Resource links provided by NLM:


Further study details as provided by National Development and Research Institutes, Inc.:

Primary Outcome Measures:
  • opiate use

Secondary Outcome Measures:
  • treatment retention
  • other drug use
  • HIV risk behavior
  • opiate craving
  • psychosocial status
  • feedback on intervention

Estimated Enrollment: 90
Study Start Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • In buprenorphine-assisted taper
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182598

Contacts
Contact: Lisa Marsch, PhD 212-845-4655 marsch@ndri.org
Contact: Honoria Guarino, PhD 212-845-4540 guarino@ndri.org

Locations
United States, New York
Dr. Steven Lee Recruiting
New York, New York, United States, 10011
Contact: Lisa Marsch, PhD    212-845-4655    marsch@ndri.org   
Contact: Honoria Guarino, PhD    212-845-4540    guarino@ndri.org   
Principal Investigator: Lisa Marsch, PhD         
Dr. Tania Taubes Recruiting
New York, New York, United States, 10023
Contact: Lisa Marsch, PhD    212-845-4655    marsch@ndri.org   
Contact: Honoria Guarino, PhD    212-845-4540    guarino@nri.org   
Principal Investigator: Lisa Marsch, PhD         
Sponsors and Collaborators
National Development and Research Institutes, Inc.
Investigators
Principal Investigator: Lisa Marsch, PhD National Development and Research Institutes, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00182598     History of Changes
Other Study ID Numbers: R42 DA14727
Study First Received: September 10, 2005
Last Updated: August 11, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by National Development and Research Institutes, Inc.:
buprenorphine
computer
treatment
opioid
heroin

Additional relevant MeSH terms:
Buprenorphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014