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

September 16, 2010
February 13, 2013
July 2010
July 2011   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01315184 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study of Computer-Based Treatment for Drug Dependence
Pilot Trial of a Therapeutic Interactive Voice Response System for Buprenorphine Maintenance: The Recovery Line Support System

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Opioid-Related Disorders
  • Heroin Dependence
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
  • 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.
    Intervention: Behavioral: 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
July 2012
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01315184
K01DA022398, K01DA022398-01A2
Yes
Brent A. Moore, Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Brent A. Moore, Ph.D. Yale University
Yale University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP