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NCT04303000 · ClinicalTrials.gov registry record · Phase 4
Increasing Naloxone Access for Persons Who Use Opioids
A Phase 4 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 4
- Development phase
- 111
- Enrollment target
NCT04303000: Completed Phase 4 study, sponsored by University of Alabama at Birmingham.
NCT04303000 is a Phase 4 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 111 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04303000, a Phase 4 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 111 participants
- Enrollment target
Study Summary
Deaths relating to opioid overdose have rapidly increased over the past two decades. Due to the serious public health concern of the opioid epidemic, federal agencies recommend employing various harm reduction interventions. The implementation of Opioid Overdose Education and Naloxone Distribution (OEND) programs is effective in reducing opioid overdose mortality, yet these programs do not reach many high-risk individuals. Traditionally, OEND program venues are found in large, urban medical centers, drug treatment facilities, and needle exchange programs. Identifying unreached, high-risk individuals and providing training and naloxone kits through online recruitment could significantly expand access to this life-saving intervention. The primary goal of the current proposed project is to examine the acceptability and feasibility of online recruitment, online opioid overdose and naloxone administration education, and postal distribution of naloxone kits.
Primary Outcome
Feasibility of online opioid overdose education and remote naloxone distribution as indicated by recruitment of at least 80 total participants in 6 months. There was not a calculated measure, and this aspect of feasibility was based on ability to recruit a set number of participants in a predetermined amount of time.
Interventions
- DRUG Opioid Overdose Education with Naloxone Distribution
- DRUG Opioid Overdose Education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2021-07-11 |
| Est. Completion | 2022-01-13 |
| Phase | Phase 4 |
What the finished NCT04303000 record still lists
NCT04303000 is an interventional study that assigns participants to a tested intervention. The registered 111 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 (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Opioid Overdose Education with Naloxone Distribution is the first listed.
NCT04303000 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04303000 about?
NCT04303000 is a clinical study titled "Increasing Naloxone Access for Persons Who Use Opioids". Deaths relating to opioid overdose have rapidly increased over the past two decades. Due to the serious public health concern of the opioid epidemic, federal agencies recommend employing various harm reduction interventions. The implementation of Opioid Overdose Education and Naloxone Distribution (...
What is the current status of trial NCT04303000?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 111 participants. The study started on 2021-07-11. Estimated completion is 2022-01-13.
What interventions are being tested in trial NCT04303000?
The interventions under investigation include: Opioid Overdose Education with Naloxone Distribution (DRUG), Opioid Overdose Education (DRUG).
Who is sponsoring clinical trial NCT04303000?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04303000's enrollment target sits among peer trials
111 726th of 2000 higher than 1,274 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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