Computer-based psychoeducational intervention and community-based substance abuse counseling in Adult Opioid-Dependence - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Adult Opioid-Dependence

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New York
  - New York, New York, United States, 10011
    - Recruiting
    - Dr. Steven Lee
    - Principal Investigator:
      
      Lisa Marsch, PhD
    - Contact:
      
      Honoria Guarino, PhD
      
      Phone Number: 212-845-4540
      
      Email: guarino@ndri.org
    - Contact:
      
      Lisa Marsch, PhD
      
      Phone Number: 212-845-4655
      
      Email: marsch@ndri.org
  - New York, New York, United States, 10023
    - Recruiting
    - Dr. Tania Taubes
    - Principal Investigator:
      
      Lisa Marsch, PhD
    - Contact:
      
      Lisa Marsch, PhD
      
      Phone Number: 212-845-4655
      
      Email: marsch@ndri.org
    - Contact:
      
      Honoria Guarino, PhD
      
      Phone Number: 212-845-4540
      
      Email: guarino@nri.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

In buprenorphine-assisted taper

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
opiate use

Secondary Outcome Measures

Outcome Measure
HIV risk behavior
feedback on intervention
treatment retention
other drug use
opiate craving
psychosocial status

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Development and Research Institutes, Inc.

Investigators

Principal Investigator: Lisa Marsch, PhD, National Development and Research Institutes, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Registration Dates

First Submitted

September 10, 2005

First Submitted That Met QC Criteria