Study of Computer-Based Treatment for Drug Dependence

Study Overview
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Brief Summary
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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.

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

Conditions
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Opioid-Related Disorders, Heroin Dependence

Intervention / Treatment
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* Behavioral: Recovery Line Support System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recovery Line Support System<br>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<br>* 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.<br>|
| No Intervention: Treatment as Usual<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interactive Voice Response, Computer-based Treatment, Opioid Agonist, Buprenorphine, Methadone