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Applying Web Technology to Buprenorphine Treatment

NCT ID: NCT00182598

Last Updated: 2008-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Brief Summary

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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

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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.

Conditions

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Adult Opioid-Dependence

Keywords

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buprenorphine computer treatment opioid heroin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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computer-based psychoeducational intervention

Intervention Type PROCEDURE

community-based substance abuse counseling

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* In buprenorphine-assisted taper
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Development and Research Institutes, Inc.

OTHER

Sponsor Role lead

Principal Investigators

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Lisa Marsch, PhD

Role: PRINCIPAL_INVESTIGATOR

National Development and Research Institutes, Inc.

Locations

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Dr. Steven Lee

New York, New York, United States

Site Status RECRUITING

Dr. Tania Taubes

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lisa Marsch, PhD

Role: CONTACT

Phone: 212-845-4655

Email: [email protected]

Honoria Guarino, PhD

Role: CONTACT

Phone: 212-845-4540

Email: [email protected]

Facility Contacts

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Lisa Marsch, PhD

Role: primary

Honoria Guarino, PhD

Role: backup

Lisa Marsch, PhD

Role: primary

Honoria Guarino, PhD

Role: backup

Other Identifiers

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R42DA014727

Identifier Type: NIH

Identifier Source: org_study_id

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