Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2025-12-29 @ 4:16 AM
Study NCT ID:
NCT04257695
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2020-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing and Pilot Testing an Opioid Tapering Protocol
Sponsor:
Albert Einstein College of Medicine
Organization:
Study Overview
Official Title:
Developing and Pilot Testing an Intervention to Increase Opioid Tapering in Primary Care
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TapPro
Brief 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.
Detailed Description:
In a 12-week randomized controlled trial based in a primary care outpatient clinic, the study will recruit 60 patients on moderate to high dose chronic opioid therapy for whom providers recommend opioid tapering and randomize 1:1 to an opioid tapering protocolized intervention (TapPro) or to usual care. Over three months, participants in the TapPro arm will visit with a clinician on the telephone on a biweekly basis in order to facilitate opioid prescribing and tapering and a pain self-care and coping curriculum. In the control arm, participants will see their primary care providers as per usual and decisions on opioid prescribing and tapering will be made by the primary care providers. Participants will be assessed throughout the study with questionnaires, urine drug screens, prescription database review, and medical record review.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K23DA044327 | NIH | None | https://reporter.nih.gov/quic… | View |