A Pilot Study of the Feasibility of Preoperative Opioid Tapering Before Spine Surgery Using Cognitive Behavioral Therapy and Measuring Postoperative Outcomes
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Pennsylvania
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
Contact Information
Primary
Eric Schwenk, MD
eric.schwenk@jefferson.edu
267-239-3319
Backup
Jeffrey Mojica, DO
jeffrey.mojica@jefferson.edu
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 45
Treatments
Active_comparator: Opioid tapering with Cognitive Behavioral Therapy (CBT) and education
The CBT group will receive two preoperative sessions and at least one postoperative session conducted via telemedicine and performed by a pain psychologist. CBT sessions will focus on training in non-pharmacologic pain-coping skills, reducing the frequency and impact of negative pain-related cognitions and emotions, and on setting realistic behavioral goals.~Patients will participate in the creation of an opioid tapering plan and will receive opioid education as well as education on how to taper opioids, the possibility of increased pain, the possibility of withdrawal symptoms, and the risks related to opioids, as well as the data on worsened perioperative outcomes in patients taking opioids.
Active_comparator: Opioid tapering with education alone
In this group patients will participate in the creation of an opioid tapering plan and will receive opioid education as well as education on how to taper opioids, the possibility of increased pain, the possibility of withdrawal symptoms, and the risks related to opioids, as well as the data on worsened perioperative outcomes in patients taking opioids.
Related Therapeutic Areas
Sponsors
Leads: Thomas Jefferson University