Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 6:45 AM
Study NCT ID:
NCT06107595
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conditioned Open Label Placebo for Postoperative Pain Management
Sponsor:
Centre de Médecine Intégrative et Complémentaire (CEMIC)
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial Evaluating the Efficacy of Conditioned Open Label Placebo (COLP) to Limit Opioid Reliance for Postoperative Pain Management
Status:
RECRUITING
Status Verified Date:
2024-02
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:
COLP
Brief Summary:
The primary objective is to evaluate the efficacy of two Conditioned Open Label Placebos (COLP): COLP pill and COLP odor to reduce opioid intake for postoperative (thoracic and spinal surgery) pain management compared to the opioid only usual treatment (TAU).
Detailed Description:
Patients, eligible for an elective thoracic or spinal surgery, will be randomized into either standard of care, COLP\_pill or COLP\_odor. Patients in COLP groups will be asked to pair each opioid intake with an open label placebo intake (either a pill or an inhalation) for postoperative (POD) day 0 to 17. From POD 2, patients in the intervention arms will be additionally asked to take OLP alone 3 times a day. Patients will have unrestricted access to pain killers. Patients will daily assess opioid intake, pain intensity, side effects, mobility and sense of agency using a e-dairy.
Study Oversight
Has Oversight DMC:
None
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?: