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Completed

NCT Number: NCT01315184

Study of Computer-Based Treatment for Drug Dependence

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

APT Foundation

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recovery Line Support System

Behavioral

Full time access (24 hours/7 days per week) to an automated, telephone-based, interactive, voice response (IVR)system for 4 weeks.

The program was developed based on a behavioral theory of substance abuse, and comprises four components: 1) self-assessment 2) learning about skills , 3) activities for current help and skills training, and 4) Feedback.

Primary outcomes

  1. Opioid Abstinence

    Time frame: 4 Weeks

    Continuous opioid abstinence as documented by weekly urinalysis

  2. Retention

    Time frame: 4 Weeks

    Retention in the study

Secondary outcomes

  1. Self Reported Drug Abstinent

    Time frame: 4 weeks

    Drug Abstinence based on weekly interviews

  2. system use

    Time frame: 4 weeks

    Call total amount, frequency, and specific system utilization

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: RLSS

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Mar 15, 2011
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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