Preoperative Opioid Tapering Before Spine Surgery

Part of paid clinical trials in Philadephia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT07221786
Status
Recruiting
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Conditions

  • Opioid Consumption, Postoperative
  • Opioid Dependency
  • Pain After Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Opioid tapering with CBT and education — OTHER
    Patients in the opioid tapering plus CBT group will set up an initial meeting with the pain physician within a few days of enrollment to set the tapering schedule. They will also have two CBT appointments set up to complete via telemedicine during the time between enrollment and surgery.
  • Opioid tapering with education alone — OTHER
    Patients in this group will be instructed to continue their opioids at the same doses and frequencies they were taking up through the day of surgery. They will set up an initial meeting within a few days of enrollment with the chronic pain physician to determine the tapering schedule which will occur over 4 weeks or more leading into surgery. The patient and pain physician will collectively agree on a tapering schedule.

Study Details

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.

Key Dates

Start date
Dec 1, 2025
Status verified
Jan 2026
Primary completion
Dec 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

proportion that achieved opioid tapering goal [ Time Frame: Perioperative prior to surgery (postoperative day 0) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson University HospitalPhiladephiaPennsylvania19107
Eric Schwenk, MD
[email protected]
919-360-0762
Jeffrey Mojica, DO
[email protected]
856-979-1643
Eric Schwenk, MD (PRINCIPAL_INVESTIGATOR)
Jeffrey Mojica, DO (SUB_INVESTIGATOR)

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By research site
Thomas Jefferson University Hospital· Philadephia, PA

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