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

Yale University

Status and phase: Completed; Phase 2

Conditions: Heroin Dependence; Opioid-Related Disorders

Treatments: Behavioral: Recovery Line Support System

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01315184

0804003684

K01DA022398-01A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Recovery Line Support System

Experimental group

Description:

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.

Treatment:

Behavioral: Recovery Line Support System

Treatment as Usual

No Intervention group

Description:

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.