Opioid-Related Disorders Clinical Trial
— RLSSOfficial title:
Pilot Trial of a Therapeutic Interactive Voice Response System for Buprenorphine Maintenance: The Recovery Line Support System
Verified date | March 2020 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | APT Foundation | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute on Drug Abuse (NIDA) |
United States,
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 |
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