Preoperative Opioid Tapering Before Spine Surgery
Recruiting · NCT07221786 · Interventional (participants receive a specific treatment) · Lead sponsor: Thomas Jefferson University
View the official record on ClinicalTrials.gov →Interventions studied
Opioid tapering with CBT and educationOpioid tapering with education alone
What this trial is about
This is a pilot study in which patients taking opioids chronically who are scheduled for spine surgery at least 4 weeks in advance will be randomly assigned to one of two groups: opioid tapering with education alone or opioid tapering with education plus cognitive behavioral therapy (CBT). The primary objective is to determine the proportion of each group that is successful in achieving their opioid tapering goals by the time of surgery.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Eligibility criteria (as published)
Inclusion:
* at least 18 years old
* scheduled for major spine surgery (i.e. at least 1 level of fusion) with hospital admission of at least one night
* scheduled for spine surgery at least 4 weeks ahead of time
* takes between 40 and 200 oral morphine equivalents daily
Exclusion:
* inability to use a computer or tablet for telemedicine encounters
* non-English-speaking
* inability to complete assessments
* positive screen on the Columbia Suicide Screening Assessment
Where it is running
2 locations listed across 1 US state.
- Thomas Jefferson University Hospital - Philadephia, Pennsylvania, United States
- Thomas Jefferson University Hospital - Philadephia, Pennsylvania, United States