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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01315184
First Posted: March 15, 2011
Last Update Posted: February 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Brent A. Moore, Yale University
  Purpose
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.

Condition Intervention Phase
Opioid-Related Disorders Heroin Dependence Behavioral: Recovery Line Support System Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Trial of a Therapeutic Interactive Voice Response System for Buprenorphine Maintenance: The Recovery Line Support System

Resource links provided by NLM:


Further study details as provided by Brent A. Moore, Yale University:

Primary Outcome Measures:
  • Opioid Abstinence [ Time Frame: 4 Weeks ]
    Continuous opioid abstinence as documented by weekly urinalysis

  • Retention [ Time Frame: 4 Weeks ]
    Retention in the study


Secondary Outcome Measures:
  • Self Reported Drug Abstinent [ Time Frame: 4 weeks ]
    Drug Abstinence based on weekly interviews

  • system use [ Time Frame: 4 weeks ]
    Call total amount, frequency, and specific system utilization


Enrollment: 36
Study Start Date: July 2010
Study Completion Date: July 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315184


Locations
United States, Connecticut
APT Foundation
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Brent A. Moore, Ph.D. Yale University
  More Information

Responsible Party: Brent A. Moore, Associate Research Scientist, Yale University
ClinicalTrials.gov Identifier: NCT01315184     History of Changes
Other Study ID Numbers: K01DA022398 ( U.S. NIH Grant/Contract )
K01DA022398-01A2 ( U.S. NIH Grant/Contract )
First Submitted: September 16, 2010
First Posted: March 15, 2011
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Brent A. Moore, Yale University:
Interactive Voice Response
Computer-based Treatment
Opioid Agonist
Buprenorphine
Methadone

Additional relevant MeSH terms:
Opioid-Related Disorders
Heroin Dependence
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists