Study of Computer-Based Treatment for Drug Dependence (RLSS)

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

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.

Study Overview

• Status: Completed
• Conditions: Opioid-Related Disorders; Heroin Dependence
• Intervention / Treatment: Behavioral: Recovery Line Support System

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • APT Foundation

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recovery Line Support System; Patients assigned to the Recovery Line Support System will be trained on the system and provided 24-hr access to the system for a four week period, provided with a Recovery notebook, and given reminder calls to contact the system.	Behavioral: Recovery Line Support System; 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.
No Intervention: Treatment as Usual; Patients assigned to the TAU condition will receive any services provided by their buprenorphine provider and any additional services that their provider refers or recommends that patients attend. No additional services will be provided by the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Abstinence	Continuous opioid abstinence as documented by weekly urinalysis	4 Weeks
Retention	Retention in the study	4 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self Reported Drug Abstinent	Drug Abstinence based on weekly interviews	4 weeks
system use	Call total amount, frequency, and specific system utilization	4 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Brent A. Moore, Ph.D., Yale University

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: September 16, 2010
• First Submitted That Met QC Criteria: March 14, 2011
• First Posted (Estimate): March 15, 2011

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Methadone; Buprenorphine; Interactive Voice Response; Computer-based Treatment; Opioid Agonist
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Heroin Dependence
• Other Study ID Numbers: 0804003684; K01DA022398-01A2 (U.S. NIH Grant/Contract)