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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: Completed Phase 2 study of Opioid-Related Disorders and Heroin Dependence, sponsored by Yale University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Continuous opioid abstinence as documented by weekly urinalysis
Conditions Studied
Interventions
- BEHAVIORAL Recovery Line Support System
Study Locations (1)
Connecticut
- APT Foundation - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
What the finished NCT01315184 record still lists
NCT01315184 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 346-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01315184's enrollment target sits among peer trials
36 37th of 47 higher than 11 of 47 other Opioid-Related Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid-Related Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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