Lowering opioid use before spine surgery
A Pilot Study of the Feasibility of Preoperative Opioid Tapering Before Spine Surgery Using Cognitive Behavioral Therapy and Measuring Postoperative Outcomes
This pilot test tries two tapering approaches for adults who take daily opioids and have spine surgery scheduled at least four weeks away—education alone versus education plus two CBT sessions—to see which helps them reduce opioids by the time of surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadephia, Pennsylvania) |
| Trial ID | NCT07221786 on ClinicalTrials.gov |
What this trial studies
This randomized pilot will enroll 45 adults taking 40–200 oral morphine milligram equivalents daily who are scheduled for major spine surgery at least four weeks in advance. Participants are assigned to personalized opioid tapering with education alone or to the same tapering plus two preoperative cognitive behavioral therapy (CBT) sessions, with pain physicians designing individual taper plans. Pain, opioid withdrawal, depression, and anxiety are monitored during the month prior to surgery and throughout hospitalization, and opioid use at the time of surgery is the primary outcome. Additional hospital outcomes, including postoperative pain, opioid requirements, complications, and length of stay, will also be recorded.
Who should consider this trial
Good fit: Adults (18+) scheduled for major spine surgery at least four weeks in advance who take 40–200 oral morphine milligram equivalents per day and can complete telemedicine visits are ideal candidates.
Not a fit: Patients who are non-English-speaking, unable to use a computer or tablet, unable to complete assessments, or who screen positive on the Columbia Suicide Severity Rating Scale are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this approach could help patients lower opioid use before spine surgery and reduce postoperative opioid exposure and related complications.
How similar studies have performed: Behavioral interventions and preoperative tapering have shown promise in observational and small studies, but randomized evidence comparing education alone versus CBT-enhanced tapering before spine surgery is limited, making this pilot relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Philadephia, Pennsylvania
- Thomas Jefferson University Hospital — Philadephia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Eric Schwenk, MD
- Email: eric.schwenk@jefferson.edu
- Phone: 267-239-3319
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.