NCT04973748Completed
Conditioned Open-label Placebo (COLP) for Peri-operative Pain Management in Patients With Head and Neck Cancer
Open-label Conditioning Therapy for Peri-operative Pain Management in Head and Neck Cancer Patients
Source: ClinicalTrials.gov · Last updated 23 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 9 Jul 2021
- Start date
- 7 Feb 2023
- Primary completion date
- 28 Jun 2024
- Lead sponsor
- Johns Hopkins University
- Diseases
- Head and neck cancer
- NCT number
- NCT04973748
What you commit to
- Study type: Interventional
- Participants enrolled: 9
- From 7 Feb 2023 to the primary completion date, 28 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to receiving acetaminophen, ibuprofen, oxycodone, or hydromorphone
- New gabapentin prescription started \<2 weeks prior to surgery
Other illness
- Past medical history of substance use disorder
- Psychosis, delirium or other significant cognitive impairment preventing participation in study
Other
- Chronic pain (defined as pain lasting \>3 months) or chronic opioid use (for \>3 months).
Who the study is looking for
- Patients receiving pre-operative evaluation for head and neck cancer in the Otolaryngology - Head and Neck Surgery Department at Johns Hopkins Hospital
- Scheduled for surgery for resection of and/or reconstruction following resection of a head and neck tumor between November 15, 2022 - May 15, 2024, with expected inpatient admission of at least 5 days after surgery.
- Age 18 years or older
- Ability to comprehend and willingness to participate in open-label conditioning portion of study regardless of study group assignment
- Ability to participate in study for 1 week prior to surgery and 6 months following surgery at time of enrollment
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.