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NCT01788306 · ClinicalTrials.gov registry record · Phase 4
Project OOPEN: Opioid Overdose Prevention, Education and Intervention
A Phase 4 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 4
- Development phase
- 256
- Enrollment target
NCT01788306: Completed Phase 4 study, sponsored by University of Washington.
NCT01788306 is a Phase 4 study that has completed, run by University of Washington. The registered enrollment target is 256 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01788306, a Phase 4 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 256 participants
- Enrollment target
Study Summary
This prospective, randomized emergency department trial will study the effectiveness of an intervention that combines opioid overdose prevention, education and intervention that includes take home naloxone with brief behavioral change counseling. The study will recruit both heroin users (n=500) and pharmaceutical opioid users at elevated risk for overdose (n=500). Outcomes of interest include subsequent opioid overdoses and overdose risk behaviors. Primary Aims The primary aims are to test whether those who receive the intervention compared to standard care have: 1) Lower rates of opioid non-fatal and fatal overdose; 2) Reduce drug use, inappropriate medication use, and other overdose risk behaviors. Secondary Aims The secondary aims are to test whether those who receive the intervention compared to standard care have: 3) More appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care); 4) Lower total health care costs; 5) Determine the prevalence of HIV risk behaviors among heroin and pharmaceutical opioid users at risk for overdose and whether the intervention impacts these behaviors.
Primary Outcome
Rate of fatal opioid overdose
Interventions
- DRUG OOPEN+BBCC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2013-01 |
| Est. Completion | 2018-10 |
| Phase | Phase 4 |
What the finished NCT01788306 record still lists
NCT01788306 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 1 intervention - of which OOPEN+BBCC is the first listed.
NCT01788306 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01788306 about?
NCT01788306 is a clinical study titled "Project OOPEN: Opioid Overdose Prevention, Education and Intervention". This prospective, randomized emergency department trial will study the effectiveness of an intervention that combines opioid overdose prevention, education and intervention that includes take home naloxone with brief behavioral change counseling. The study will recruit both heroin users (n=500) and ...
What is the current status of trial NCT01788306?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 256 participants. The study started on 2013-01. Estimated completion is 2018-10.
What interventions are being tested in trial NCT01788306?
The interventions under investigation include: OOPEN+BBCC (DRUG).
Who is sponsoring clinical trial NCT01788306?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01788306's enrollment target sits among peer trials
256 332nd of 2000 higher than 1,667 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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