Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07221786

A Pilot Study of Preoperative Opioid Tapering Using Cognitive Behavioral Therapy and Education Before Spine Surgery and Measuring Postoperative Outcomes

Led by Thomas Jefferson University · Updated on 2026-03-24

45

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate opioid tapering methods in patients who are chronically using opioids and scheduled for spine surgery at least four weeks later. The study focuses on comparing opioid tapering with education alone versus opioid tapering combined with cognitive behavioral therapy (CBT). It addresses challenges faced by opioid-dependent patients in the perioperative period, including pain control difficulties and higher risks of complications and prolonged opioid use after spine surgery. Participants will be randomly assigned to one of two groups: one receiving opioid tapering with education alone, and the other receiving opioid tapering with education plus CBT. All patients will work with a pain physician to create a personalized tapering plan. The CBT group will have two sessions before surgery and one session after surgery via telemedicine. Both groups will receive education about opioid tapering, potential withdrawal symptoms, increased pain, and risks of opioids. Throughout the study, pain, depression, anxiety, and withdrawal symptoms will be assessed before and after surgery. Hospital outcomes like pain levels, opioid use, recovery quality, and complications will be tracked. Follow-up assessments will be conducted at 30, 90, 180, and 365 days after surgery via phone or Zoom to monitor pain, function, and opioid use. The primary outcome is the proportion of patients who reach their opioid tapering goals by the time of surgery.

CONDITIONS

Brief Title

Preoperative Opioid Tapering Before Spine Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old
  • Scheduled for major spine surgery involving at least one level of fusion
  • Planned hospital admission of at least one night
  • Surgery scheduled at least 4 weeks ahead of time
  • Taking between 40 and 200 oral morphine equivalents daily
Not Eligible

You will not qualify if you...

  • Unable to use a computer or tablet for telemedicine visits
  • Non-English-speaking
  • Unable to complete study assessments
  • Positive screen on the Columbia Suicide Screening Assessment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Preoperative Opioid Tapering

Duration - 4 weeks or more leading up to surgery

Participants work with a pain physician to create a personalized opioid tapering plan. Those in the cognitive behavioral therapy (CBT) group will have two telemedicine CBT sessions before surgery focusing on pain coping skills, while the education-only group receives opioid education and tapering guidance.

1 initial meeting with a pain physician and 2 telemedicine CBT sessions for the CBT group

Surgery

Duration - Hospital stay of at least one night

Participants undergo major spine surgery with hospital admission of at least one night. Opioid use, pain, and other outcomes are assessed during the hospital stay.

Daily assessments during hospital stay (up to 7 days)

Postoperative Follow-up and Monitoring

Duration - 12 months following surgery

After discharge, participants are followed by a chronic pain physician. The CBT group receives one additional telemedicine CBT session. Participants are assessed for pain, function, opioid use, and other outcomes via telephone or Zoom at 30, 90, 180, and 365 days after surgery.

Telemedicine or telephone assessments at 4 time points (30, 90, 180, and 365 days) and 1 additional CBT session for the CBT group

Trial Site Locations

Total: 1 location

1

Thomas Jefferson University Hospital

Philadephia, Pennsylvania, United States, 19107

Actively Recruiting

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Research Team

E

Eric Schwenk, MD

J

Jeffrey Mojica, DO

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial.

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https://pubmed.ncbi.nlm.nih.gov/34398206

A preoperative interdisciplinary biopsychosocial opioid reduction program in patients on chronic opioid analgesia prior to spine surgery: A preliminary report and case series.

Sameer Hassamal, Margaret Haglund, Karl Wittnebel...

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Preoperative Chronic Opioid Therapy Negatively Impacts Long-term Outcomes Following Cervical Fusion Surgery.

Piyush Kalakoti, Alexander J Volkmar, Nicholas A Bedard...

https://pubmed.ncbi.nlm.nih.gov/30973507

Risk Factors for Prolonged Opioid Use and Effects of Opioid Tolerance on Clinical Outcomes After Anterior Cervical Discectomy and Fusion Surgery.

Ariana A Reyes, Jose A Canseco, John J Mangan...

https://pubmed.ncbi.nlm.nih.gov/32604353