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NCT04973748 · ClinicalTrials.gov registry record · NA
Conditioned Open-label Placebo (COLP) for Peri-operative Pain Management in Patients With Head and Neck Cancer
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 9
- Enrollment target
NCT04973748: Completed NA study, sponsored by Johns Hopkins University.
NCT04973748 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04973748, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
Study Summary
The opioid epidemic is a considerable problem in the United States, and prescription opioids significantly contribute to the epidemic. Head and neck cancer (HNC) patients are inherently at increased risk for opioid dependence as surgical treatment can cause significant pain and up to 50% of patients also suffer from psychiatric comorbidities. Novel methods are needed to decrease opioid consumption following HNC surgeries to limit the risk of chronic opioid dependence in these patients. Conditioning therapy with placebo aims to elicit a classically conditioned response to an inactive medication through consistent pairing of the medication with a neutral stimulus (i.e. an odor) and has been shown to be effective for decreasing the amount of active drug require for certain clinical responses, including for acute pain. However, studies have not been completed for the treatment of acute pain in the inpatient post-operative setting. The overall goal of this pilot study is to determine the feasibility and effectiveness of conditioned open-label placebo (COLP) as an adjunct for post-operative pain management in complex head and neck cancer patients. This randomized, controlled, open-label trial will specifically compare post-operative opioid consumption and pain scales between patients receiving multimodal analgesia along with conditioned open-label placebo (COLP group) to those receiving multimodal analgesia, alone (Treatment as usual group). Findings from this study will determine the efficacy of COLP as an innovative approach to decrease opioid consumption and improve pain control in head and neck cancer patients and will provide rationale for development of future large scale trials.
Interventions
- BEHAVIORAL Conditioned open-label placebo (COLP)
- BEHAVIORAL Surveys about pain, opioid use and depression symptoms
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2023-02-07 |
| Est. Completion | 2024-06-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04973748
The ClinicalTrials.gov registry entry for NCT04973748 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Conditioned open-label placebo (COLP) is the first listed.
NCT04973748 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04973748 about?
NCT04973748 is a clinical study titled "Conditioned Open-label Placebo (COLP) for Peri-operative Pain Management in Patients With Head and Neck Cancer". The opioid epidemic is a considerable problem in the United States, and prescription opioids significantly contribute to the epidemic. Head and neck cancer (HNC) patients are inherently at increased risk for opioid dependence as surgical treatment can cause significant pain and up to 50% of patients...
What is the current status of trial NCT04973748?
This trial is currently completed. It is a NA study. The enrollment target is 9 participants. The study started on 2023-02-07. Estimated completion is 2024-06-28.
What interventions are being tested in trial NCT04973748?
The interventions under investigation include: Conditioned open-label placebo (COLP) (BEHAVIORAL), Surveys about pain, opioid use and depression symptoms (BEHAVIORAL).
Who is sponsoring clinical trial NCT04973748?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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