Study of Computer-Based Treatment for Drug Dependence

NCT ID: NCT01315184

Last Updated: 2020-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-07-31

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.

Detailed Description

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Conditions

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Opioid-Related Disorders Heroin Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Recovery Line Support System

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brent A. Moore, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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APT Foundation

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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K01DA022398-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0804003684

Identifier Type: -

Identifier Source: org_study_id

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