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NCT03906721 · ClinicalTrials.gov registry record · Phase 2
Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Patients With Spinal Cord Injury, Polytrauma and Burn Injury
A Phase 2 study of Spinal Cord Injuries and Burn Injury, sponsored by Spaulding Rehabilitation Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03906721: Completed Phase 2 study of Spinal Cord Injuries and Burn Injury, sponsored by Spaulding Rehabilitation Hospital.
NCT03906721 is a Phase 2 study of Spinal Cord Injuries and Burn Injury that has completed, run by Spaulding Rehabilitation Hospital. The registered enrollment target is 30 participants, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03906721, a Phase 2 study of Spinal Cord Injuries and Burn Injury, has completed, sponsored by Spaulding Rehabilitation Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The use of conditioning open-label placebo (COLP) will be studied as a dose extension method to lower opioid dosage in patients with spinal cord injury, polytrauma, and burn injury. The goal is to provide the same level of pain relief with a reduced opioid dose to diminish adverse effects as well as the risk of addiction associated with narcotic treatment.
Primary Outcome
Morphine Milligram Equivalents (MME) are used to standardize opioid exposure by expressing the analgesic potency of different opioids relative to morphine. MME is calculated by multiplying the prescribed opioid dose by the daily frequency of administration and then by an opioid-specific conversion factor. The resulting value is expressed as milligrams of morphine equivalents (mg MME). Values range from 0 mg MME upward, with higher values indicating greater opioid exposure, which has been associa
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Oxycodone
- OTHER Essential Oil
Study Locations (1)
Massachusetts
- Spaulding Rehabilitation Hospital - Charlestown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-02-20 |
| Est. Completion | 2021-11-01 |
| Phase | Phase 2 |
What the finished NCT03906721 record still lists
NCT03906721 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (51% lower).
The record links to 3 conditions, with Spinal Cord Injuries appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03906721 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03906721 about?
NCT03906721 is a clinical study titled "Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Patients With Spinal Cord Injury, Polytrauma and Burn Injury". The use of conditioning open-label placebo (COLP) will be studied as a dose extension method to lower opioid dosage in patients with spinal cord injury, polytrauma, and burn injury. The goal is to provide the same level of pain relief with a reduced opioid dose to diminish adverse effects as well as...
What is the current status of trial NCT03906721?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2019-02-20. Estimated completion is 2021-11-01.
What conditions does trial NCT03906721 study?
This clinical trial studies the following conditions: Spinal Cord Injuries, Burn Injury, Polytrauma.
What interventions are being tested in trial NCT03906721?
The interventions under investigation include: Placebo (DRUG), Oxycodone (DRUG), Essential Oil (OTHER).
Who is sponsoring clinical trial NCT03906721?
This trial is sponsored by Spaulding Rehabilitation Hospital, which has 101 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03906721 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03906721's enrollment target sits among peer trials
30 90th of 202 higher than 99 of 202 other Spinal Cord Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injuries 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.
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