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NCT01315184 · ClinicalTrials.gov registry record · Phase 2

Study of Computer-Based Treatment for Drug Dependence

A Phase 2 study of Opioid-Related Disorders and Heroin Dependence, sponsored by Yale University.

Completed
Registry status
Phase 2
Development phase
36
Enrollment target
1
Study location

NCT01315184 is a Phase 2 study of Opioid-Related Disorders and Heroin Dependence that has completed, run by Yale University. The registered enrollment target is 36 participants, below the 346-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01315184, a Phase 2 study of Opioid-Related Disorders and Heroin Dependence, has completed, sponsored by Yale University.

COMPLETED
Registry status
Phase 2
Development phase
36 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • BEHAVIORAL Recovery Line Support System

Study Locations (1)

Connecticut

  • APT Foundation - New Haven

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2010-07
Est. Completion 2012-07
Phase Phase 2

Sponsor

Yale University

1,492 total trials

What the Registry Record Tells You About NCT01315184

The ClinicalTrials.gov registry entry for NCT01315184 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 346-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (90% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Opioid-Related Disorders appearing as the primary indexed condition, and to 1 intervention - of which Recovery Line Support System is the first listed.

NCT01315184 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.

Frequently Asked Questions

What is clinical trial NCT01315184 about?

NCT01315184 is a clinical study titled "Study of Computer-Based Treatment for Drug Dependence". 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 ther...

What is the current status of trial NCT01315184?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2010-07. Estimated completion is 2012-07.

What conditions does trial NCT01315184 study?

This clinical trial studies the following conditions: Opioid-Related Disorders, Heroin Dependence.

What interventions are being tested in trial NCT01315184?

The interventions under investigation include: Recovery Line Support System (BEHAVIORAL).

Who is sponsoring clinical trial NCT01315184?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01315184 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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