Study of Computer-Based Treatment for Drug Dependence

Phase 2

Completed

• Conditions: Heroin Dependence; Opioid-Related Disorders
• Interventions: Behavioral: Recovery Line Support System

• Registration Number: NCT01315184
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Primary Completion: 2011-07
• Study Completion: 2012-07
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recovery Line Support System	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.

Primary Outcome Measures

Name	Time	Method
Retention	4 Weeks	Retention in the study
Opioid Abstinence	4 Weeks	Continuous opioid abstinence as documented by weekly urinalysis

Secondary Outcome Measures

Name	Time	Method
Self Reported Drug Abstinent	4 weeks	Drug Abstinence based on weekly interviews
system use	4 weeks	Call total amount, frequency, and specific system utilization

Trial Locations

Locations (1)

APT Foundation; 🇺🇸 New Haven, Connecticut, United States