Preoperative Opioid Tapering 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 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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Dependency; Opioid Consumption, Postoperative; Pain After Surgery
• Intervention / Treatment: Other: Opioid tapering with CBT and education; Other: Opioid tapering with education alone

Detailed Description

The perioperative period represents a particularly problematic time for opioid-dependent patients. Perioperative pain is often difficult to control, with opioid tolerance, opioid-induced hyperalgesia, and withdrawal making management a challenge. In addition to these short-term challenges, opioid-dependent patients experience poorer outcomes after surgery, including both early and late complications, emergency room visits, infections, and reoperations. Spine surgery in opioid-tolerant patients increases the risk for prolonged postoperative opioid use. This risk is in addition to the risk of prolonged opioid use that surgery itself introduces. The high prevalence of opioid use in spine patients makes spine surgery an ideal surgical model in which to study opioid tapering.

This is a randomized, controlled pilot study of 45 opioid-dependent patients undergoing spine surgery. Patients will be assigned in parallel to one of the following: 1. opioid tapering with education alone or 2. opioid tapering with education plus cognitive behavioral therapy (CBT). While all patients will meet with a pain physician to design a personalized tapering program, the CBT group will receive two CBT sessions prior to surgery. Pain, depression, anxiety, and opioid withdrawal will be assessed throughout the month prior to surgery and managed appropriately. Opioid use at the time of surgery will be assessed along with pain and depression and anxiety. Hospital outcomes, including pain, opioid use, quality of recovery, and postoperative complications, will be measured. Patients will be followed upon discharge by a chronic pain physician and patients assigned to CBT will receive one additional session after surgery. All patients will also be assessed via telephone call or Zoom at 30, 90, 180, and 365 days for pain, function, and opioid use.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeffrey Mojica, DO; Email: jeffrey.mojica@jefferson.edu
• Study Contact Backup: Name: Eric Schwenk, MD; Phone Number: 267-239-3319; Email: eric.schwenk@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadephia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital
      • Contact: Eric Schwenk, MD; Phone Number: 919-360-0762; Email: eric.schwenk@jefferson.edu
      • Contact: Jeffrey Mojica, DO; Phone Number: 856-979-1643; Email: jeffrey.mojica@jefferson.edu
      • Principal Investigator: Eric Schwenk, MD
      • Sub-Investigator: Jeffrey Mojica, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Opioid tapering with CBT and education; 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.
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.	Other: Opioid tapering with education alone; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion that achieved opioid tapering goal	Achievement of the opioid tapering goal for each patient will be assessed on day of surgery and will be based on average daily OMEs taken during the three days before surgery. The opioid tapering goal will be made on the initial visit with the study pain physician and will be specific to each patient.	Perioperative prior to surgery (postoperative day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory	Brief Pain Inventory is a validated pain assessment tool that measures pain severity and its effects on daily function.	Baseline, weeks 1-4 before surgery, day of surgery (postoperative day 0), postoperative days 1-3, and postoperative days 30, 90, 180 and 365.
Clinical Opiate Withdrawal Scale	Standardized assessment of opioid withdrawal	Baseline, once weekly on weeks 1-4 prior to surgery, day of surgery (postoperative day 0), postoperative day 1, and postoperative days 30, 90, 180, and 365.
Patient Health Questionnaire-9	Depression screening	Baseline, weeks 1-4 prior to surgery, and postoperative days 30, 90, 180, and 365
Generalized Anxiety Disorder-2	Standardized generalized anxiety screening	Baseline
Columbia Suicide Screening Assessment	This is a suicide risk screening tool	Screening period
Daily opioid use in hospital	This will be the average daily opioid use in the hospital	Postoperative days 0-7
Hospital length of stay	Duration of hospital stay in days	Postoperative days 0-7
Quality of recovery-15	This is a validated 15-question assessment of quality of recovery	Preoperative baseline, postoperative days 1-2
Hospital Anxiety and Depression Scale	Anxiety and depression assessment for the hospitalization	Postoperative days 0-3
Opioid use in daily OMEs	Patient-reported daily opioid use on average in mg	Day of surgery (postoperative day 0), postoperative days 30, 90, 180 and 365
Daily opioid use in OMEs from prescription drug monitoring program	This is the prescribed daily opioids confirmed from the PDMP.	Day of surgery (postoperative day 0), postoperative days 30, 90, 180, and 365
Nausea and vomiting	Nausea and vomiting measured on the following scale: 0=AE not experienced; 1=AE experienced but no treatment needed; 2=AE experienced and treatment was effective; 3=AE experienced and treatment was ineffective	Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365
Constipation	Constipation: 0=AE not experienced; 1=AE experienced but no treatment needed; 2=AE experienced and treatment was effective; 3=AE experienced and treatment was ineffective	Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365
Pruritus	Puritus: 0=AE not experienced; 1=AE experienced but no treatment needed; 2=AE experienced and treatment was effective; 3=AE experienced and treatment was ineffective	Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365
Patient satisfaction with pain control	0-10 scale with 0 being worst possible pain control and 10 being best possible pain control	Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365
SF-12	This is a brief assessment of physical and mental function	Baseline, day of surgery (postoperative day 0), and postoperative days 30, 90, 180, and 365

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Publications and helpful links

General Publications

• Colvin LA, Bull F, Hales TG. Perioperative opioid analgesia-when is enough too much? A review of opioid-induced tolerance and hyperalgesia. Lancet. 2019 Apr 13;393(10180):1558-1568. doi: 10.1016/S0140-6736(19)30430-1.
• Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
• Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298.
• Darnall BD, Roy A, Chen AL, Ziadni MS, Keane RT, You DS, Slater K, Poupore-King H, Mackey I, Kao MC, Cook KF, Lorig K, Zhang D, Hong J, Tian L, Mackey SC. 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. JAMA Netw Open. 2021 Aug 2;4(8):e2113401. doi: 10.1001/jamanetworkopen.2021.13401.
• Hassamal S, Haglund M, Wittnebel K, Danovitch I. A preoperative interdisciplinary biopsychosocial opioid reduction program in patients on chronic opioid analgesia prior to spine surgery: A preliminary report and case series. Scand J Pain. 2016 Oct;13:27-31. doi: 10.1016/j.sjpain.2016.06.007. Epub 2016 Jul 4.
• Bicket MC, Gunaseelan V, Lagisetty P, Fernandez AC, Bohnert A, Assenmacher E, Sequeira M, Englesbe MJ, Brummett CM, Waljee JF. Association of opioid exposure before surgery with opioid consumption after surgery. Reg Anesth Pain Med. 2022 Jun;47(6):346-352. doi: 10.1136/rapm-2021-103388. Epub 2022 Mar 3.
• Kalakoti P, Volkmar AJ, Bedard NA, Eisenberg JM, Hendrickson NR, Pugely AJ. Preoperative Chronic Opioid Therapy Negatively Impacts Long-term Outcomes Following Cervical Fusion Surgery. Spine (Phila Pa 1976). 2019 Sep;44(18):1279-1286. doi: 10.1097/BRS.0000000000003064.
• Reyes AA, Canseco JA, Mangan JJ, Divi SN, Goyal DKC, Bowles DR, Patel PD, Salmons HI, Morgenstern M, Anderson DG, Rihn JA, Kurd MF, Hilibrand AS, Kepler CK, Vaccaro AR, Schroeder GD. Risk Factors for Prolonged Opioid Use and Effects of Opioid Tolerance on Clinical Outcomes After Anterior Cervical Discectomy and Fusion Surgery. Spine (Phila Pa 1976). 2020 Jul 15;45(14):968-975. doi: 10.1097/BRS.0000000000003511.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 23, 2025
• First Submitted That Met QC Criteria: October 27, 2025
• First Posted (Actual): October 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: depression; opioid dependence; anxiety; cognitive behavioral therapy; opioids; pain management; spine surgery; opioid use; opioid tapering
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurobehavioral Manifestations; Substance-Related Disorders; Chemically-Induced Disorders; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Anxiety Disorders; Opioid-Related Disorders; Depression; Agnosia; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: IRB Control #22D.843_JT#25484

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No