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

Primary Purpose

Opioid-Related Disorders, Heroin Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Recovery Line Support System
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Related Disorders focused on measuring Interactive Voice Response, Computer-based Treatment, Opioid Agonist, Buprenorphine, Methadone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • APT Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Recovery Line Support System

Treatment as Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Opioid Abstinence
Continuous opioid abstinence as documented by weekly urinalysis
Retention
Retention in the study

Secondary Outcome Measures

Self Reported Drug Abstinent
Drug Abstinence based on weekly interviews
system use
Call total amount, frequency, and specific system utilization

Full Information

First Posted
September 16, 2010
Last Updated
March 31, 2020
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01315184
Brief Title
Study of Computer-Based Treatment for Drug Dependence
Acronym
RLSS
Official Title
Pilot Trial of a Therapeutic Interactive Voice Response System for Buprenorphine Maintenance: The Recovery Line Support System
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Heroin Dependence
Keywords
Interactive Voice Response, Computer-based Treatment, Opioid Agonist, Buprenorphine, Methadone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recovery Line Support System
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Recovery Line Support System
Intervention Description
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 Outcome Measure Information:
Title
Opioid Abstinence
Description
Continuous opioid abstinence as documented by weekly urinalysis
Time Frame
4 Weeks
Title
Retention
Description
Retention in the study
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
Self Reported Drug Abstinent
Description
Drug Abstinence based on weekly interviews
Time Frame
4 weeks
Title
system use
Description
Call total amount, frequency, and specific system utilization
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent A. Moore, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
APT Foundation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Computer-Based Treatment for Drug Dependence

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