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NCT04257695 · ClinicalTrials.gov registry record · NA
Developing and Pilot Testing an Opioid Tapering Protocol
A NA study, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT04257695: Completed NA study, sponsored by Albert Einstein College of Medicine.
NCT04257695 is a NA study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04257695, a NA study, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study Summary
This study proposes to pilot test an intervention to facilitate opioid pain reliever (OPR) tapering in primary care. The intervention will incorporate a clinician embedded within primary care to follow tapering dose schedules to support providers as well to deliver a psychosocial curriculum to support and engage patients. In a pilot randomized controlled trial (RCT), the study will examine the preliminary efficacy and feasibility of the manualized, protocol-based tapering intervention ("TapPro") compared to usual care. As there is no standard definition or outcome for tapering, the primary efficacy outcome is a decrease in OPR dose over six months. Separately, the study proposes a clinically meaningful dose reduction (greater than or equal to 30 percent) as a secondary outcome. The central hypotheses' are that a tapering intervention with patient and provider support is feasible in a primary care setting and can result in greater dose reduction when compared to usual care.
Primary Outcome
Repeated measure analysis of opioid dosage over six months
Interventions
- BEHAVIORAL TapPro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2021-05-04 |
| Est. Completion | 2023-08-31 |
| Phase | NA |
What the finished NCT04257695 record still lists
NCT04257695 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which TapPro is the first listed.
NCT04257695 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04257695 about?
NCT04257695 is a clinical study titled "Developing and Pilot Testing an Opioid Tapering Protocol". This study proposes to pilot test an intervention to facilitate opioid pain reliever (OPR) tapering in primary care. The intervention will incorporate a clinician embedded within primary care to follow tapering dose schedules to support providers as well to deliver a psychosocial curriculum to suppo...
What is the current status of trial NCT04257695?
This trial is currently completed. It is a NA study. The enrollment target is 2 participants. The study started on 2021-05-04. Estimated completion is 2023-08-31.
What interventions are being tested in trial NCT04257695?
The interventions under investigation include: TapPro (BEHAVIORAL).
Who is sponsoring clinical trial NCT04257695?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04257695's enrollment target sits among peer trials
2 1997th of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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