NCT04973748

Conditioned Open-label Placebo (COLP) for Peri-operative Pain Management in Patients With Head and Neck Cancer

Completed NA Last updated 23 August 2024

What this trial tests

NA trial testing Conditioned open-label placebo (COLP) in Postoperative Pain in 9 participants. Completed in 28 June 2024.

Timeline

7 February 2023

Primary endpoint
28 June 2024

28 June 2024

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	9
Start date	7 February 2023
Primary completion	28 June 2024
Estimated completion	28 June 2024
Sites	1 location across United States

Drugs / interventions tested

• Conditioned open-label placebo (COLP)
• Surveys about pain, opioid use and depression symptoms

Conditions studied

• Postoperative Pain — all drugs for Postoperative Pain →
• Opioid Use — all drugs for Opioid Use →

Sponsor

Johns Hopkins University

Who can join

18 and older, any sex, with Postoperative Pain or Opioid Use. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Study protocol: randomised controlled trial of conditioned open-label placebo (COLP) for perioperative pain management in patients with head and neck cancer.
   Trakimas DR, Colloca L, Fakhry C, Tan M, et al · · 2023 · PMID 37419646 · DOI 10.1136/bmjopen-2022-069785