Evaluation of Open-Label Conditioned Placebo Analgesia for Postoperative Opioid Reduction Following Spinal Fusion
COLP
1 other identifier
interventional
51
1 country
1
Brief Summary
This research aims to understand the impact of conditioned open label placebo (COLP) on opioid consumption and pain after surgery. The hypothesis being tested is that by pairing a non-deceptive placebo pill with regularly prescribed pain killers after surgery, will allow reduction in opioids taken while maintaining the same level of analgesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2018
CompletedFirst Submitted
Initial submission to the registry
December 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedSeptember 13, 2021
September 1, 2021
1.3 years
December 6, 2018
September 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
self administration of PRN opioids
daily report of post-discharge opioid use in sub-acute postoperative period, converted into morphine milligram equivalents
day 3-17
acute postoperative pain
daily brief pain inventory (BPI)
day 3-17
Study Arms (2)
open label placebo
ACTIVE COMPARATORparticipants will take open label placebo pills TID and in conjunction with other PRN analgesics
treatment as usual
NO INTERVENTIONparticipants will take PRN analgesics as usual
Interventions
open label placebo pill
Eligibility Criteria
You may qualify if:
- (1) aged 18-75 years, (2) scheduled for spinal fusion surgery up to, and including 4 levels, (3) able to comprehend and willingness to participate in COLP, (4) willingness to undergo psychophysical and psychosocial testing (5) willingness to participate in long-term follow-up.
You may not qualify if:
- (1) delirium, psychosis, or other cognitive impairment limiting completion of study procedures (2) non-English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
Flowers KM, Patton ME, Hruschak VJ, Fields KG, Schwartz E, Zeballos J, Kang JD, Edwards RR, Kaptchuk TJ, Schreiber KL. Conditioned open-label placebo for opioid reduction after spine surgery: a randomized controlled trial. Pain. 2021 Jun 1;162(6):1828-1839. doi: 10.1097/j.pain.0000000000002185.
PMID: 33449503DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Kristin Schreiber, M.D., Ph.D.
Brigham and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Principle Investigator
Study Record Dates
First Submitted
December 6, 2018
First Posted
October 5, 2020
Study Start
November 30, 2018
Primary Completion
March 10, 2020
Study Completion
March 10, 2020
Last Updated
September 13, 2021
Record last verified: 2021-09