Study of Computer-Based Treatment for Drug Dependence (RLSS)
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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 |
- 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
- 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 |
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
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 May 16, 2013