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NCT02360007 · ClinicalTrials.gov registry record · Phase 1
Interim Buprenorphine: Leveraging Medication + Technology to Bridge Delays in Treatment Access
A Phase 1 study, sponsored by University of Vermont Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT02360007 is a Phase 1 study that has completed, run by University of Vermont Medical Center. The registered enrollment target is 70 participants.
The verdict
NCT02360007, a Phase 1 study, has completed, sponsored by University of Vermont Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study Summary
Despite the undisputed effectiveness of agonist maintenance for treating opioid dependence, current capacity is inadequate to meet need in the U.S. and internationally. Indeed, an alarming number of clinics have extensive waitlists for treatment slots. Patients can remain on these waitlists for years, placing them at elevated risk for illicit drug use, criminal activity, infectious disease, overdose and mortality during this period. These delays in treatment access represent a significant barrier to the widespread delivery of effective opioid treatment, and there is a critical need to develop creative new approaches for mitigating these delays. Our overarching goal in this application is to develop a novel Interim Buprenorphine Treatment (IBT) that can bridge delays in treatment access. Our integrative treatment package includes five key components, each strategically chosen to maximize patient access to pharmacotherapy for opioid dependence while minimizing nonadherence, abuse and diversion: Buprenorphine, Computerized adherence monitoring, mHealth clinical support delivered via Interactive Voice Response, Automated random call-backs for urinalysis and adherence monitoring, and HIV+Hepatitis Education delivered via iPad. The Primary Aim of this Stage I Behavioral and Integrative Treatment Development application is to evaluate the feasibility and initial efficacy of IBT in a 12-week randomized trial in which 70 opioid-dependent adults wait-listed for agonist maintenance are randomized to receive IBT (n=35) or continue in a Waitlist Control condition (WLC; n=35). WLC participants who have not entered treatment by Week 12 will be offered the opportunity to cross over to IBT at that time, contributing additional within-subject data with which to evaluate the efficacy of the IBT intervention. The proposed research is innovative in several important ways: By facilitating the eradication of waitlists for opioid treatment, it represents a significant departure from the st
Interventions
- DRUG Interim Buprenorphine Treatment (IBT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02360007
The ClinicalTrials.gov registry entry for NCT02360007 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont Medical Center, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Interim Buprenorphine Treatment (IBT) is the first listed.
NCT02360007 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02360007 about?
NCT02360007 is a clinical study titled "Interim Buprenorphine: Leveraging Medication + Technology to Bridge Delays in Treatment Access". Despite the undisputed effectiveness of agonist maintenance for treating opioid dependence, current capacity is inadequate to meet need in the U.S. and internationally. Indeed, an alarming number of clinics have extensive waitlists for treatment slots. Patients can remain on these waitlists for year...
What is the current status of trial NCT02360007?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2015-01. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02360007?
The interventions under investigation include: Interim Buprenorphine Treatment (IBT) (DRUG).
Who is sponsoring clinical trial NCT02360007?
This trial is sponsored by University of Vermont Medical Center, which has 27 total clinical trials registered on ClinicalTrials.gov.
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