Study of Computer-Based Treatment for Drug Dependence

Opioid-Related Disorders Clinical Trial

— RLSS  

Official title:

Pilot Trial of a Therapeutic Interactive Voice Response System for Buprenorphine Maintenance: The Recovery Line Support System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01315184
• Other study ID #: 0804003684
• Secondary ID: K01DA022398-01A2
• Status: Completed
• Phase: Phase 2
• Start date: July 2010
• Est. completion date: July 2012

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heroin Dependence
• Opioid-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	APT Foundation	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Abstinence	Continuous opioid abstinence as documented by weekly urinalysis	4 Weeks
Primary	Retention	Retention in the study	4 Weeks
Secondary	Self Reported Drug Abstinent	Drug Abstinence based on weekly interviews	4 weeks
Secondary	system use	Call total amount, frequency, and specific system utilization	4 weeks