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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: Completed Phase 1 study, sponsored by University of Vermont Medical Center.
NCT02360007 is a Phase 1 study that has completed, run by University of Vermont Medical Center. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
IBT and WLC experimental groups will be compared on percentage of subjects abstinent for illicit opioids across Week 4, 8, and 12 assessments
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 |
What the finished NCT02360007 record still lists
NCT02360007 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 1 intervention - of which Interim Buprenorphine Treatment (IBT) is the first listed.
NCT02360007 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02360007's enrollment target sits among peer trials
70 749th of 2000 higher than 1,227 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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