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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01315184
Other study ID # 0804003684
Secondary ID K01DA022398-01A2
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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