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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Brent A. Moore, Yale University
ClinicalTrials.gov Identifier:
NCT01315184
First received: September 16, 2010
Last updated: February 13, 2013
Last verified: February 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Yale University:

Primary Outcome Measures:
  • Opioid Abstinence [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    Continuous opioid abstinence as documented by weekly urinalysis

  • Retention [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    Retention in the study


Secondary Outcome Measures:
  • Self Reported Drug Abstinent [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Drug Abstinence based on weekly interviews

  • system use [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

Other Name: Recovery Line support system
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315184

Locations
United States, Connecticut
APT Foundation
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Brent A. Moore, Ph.D. Yale University
  More Information

Additional Information:
No publications provided

Responsible Party: Brent A. Moore, Associate Research Scientist, Yale University
ClinicalTrials.gov Identifier: NCT01315184     History of Changes
Other Study ID Numbers: K01DA022398, K01DA022398-01A2
Study First Received: September 16, 2010
Last Updated: February 13, 2013
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Interactive Voice Response
Computer-based Treatment
Opioid Agonist
Buprenorphine
Methadone

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

ClinicalTrials.gov processed this record on July 26, 2014