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Clinical Trials/NCT01315184
NCT01315184
Completed
Phase 2

Pilot Trial of a Therapeutic Interactive Voice Response System for Buprenorphine Maintenance: The Recovery Line Support System

Yale University1 site in 1 country36 target enrollmentJuly 2010

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Opioid-Related Disorders
Sponsor
Yale University
Enrollment
36
Locations
1
Primary Endpoint
Opioid Abstinence
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the whether an automated telephone-based system is useful and helpful for opioid dependent patients receiving buprenorphine in primary care. The Recovery Line support system is a Therapeutic Interactive Voice Response system based on cognitive behavioral therapy (CBT). The Recovery Line support system includes a variety of modules presenting the basic principles and strategies of CBT. Each module includes learning sections and activities sections to provide direct guidance in using skills. The Recovery Line support system is interactive and also includes a questionnaire to help patients identify problems and recommend modules for use, as well as an inspiration section, an introduction, and an immediate assistance menu. Following development of an initial system the current trial will recruit 40 patients receiving buprenorphine maintenance from a physician provider in the local community. Patients will be randomly (flip of a coin) to receive the Recover Line Support system or to treatment as usual with their physician. Patients assigned to TIVR will be trained on the system and provided 24-hr access to the TIVR system for a four week period. Primary outcome variables will be how long patients remain in treatment, self-reported abstinence from opioids and other drugs, and abstinence as measured by weekly drug screens. It is expected that patients assigned to TIVR will better treatment outcomes than patients assigned to TAU.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
July 2012
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • are at least 18 years old
  • have initiated buprenorphine maintenance treatment from an approved physician in the previous two weeks

Exclusion Criteria

  • are a current suicide or homicide risk or meet criteria for psychiatric disorder that would interfere with ability to complete study
  • are unable to read or understand English
  • have a life-threatening or unstable medical problem

Outcomes

Primary Outcomes

Opioid Abstinence

Time Frame: 4 Weeks

Continuous opioid abstinence as documented by weekly urinalysis

Retention

Time Frame: 4 Weeks

Retention in the study

Secondary Outcomes

  • Self Reported Drug Abstinent(4 weeks)
  • system use(4 weeks)

Study Sites (1)

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