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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 is a Phase 4 study that has completed, run by University of Washington. The registered enrollment target is 256 participants.
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.
Interventions
- DRUG OOPEN+BBCC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2013-01 |
| Est. Completion | 2018-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01788306
The ClinicalTrials.gov registry entry for NCT01788306 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which OOPEN+BBCC is the first listed.
NCT01788306 reports 0 study locations.
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.
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