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NCT Number: NCT07221786

Preoperative Opioid Tapering Before Spine Surgery

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.

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Key information

Conditions

Opioid Consumption, Postoperative Agnosia Anxiety Disorders Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Mental Disorders Narcotic-Related Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Opioid Dependency Opioid-Related Disorders Pain After Surgery Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University Hospital

Philadephia, Pennsylvania, 19107, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. proportion that achieved opioid tapering goal

    Time frame: Perioperative prior to surgery (postoperative day 0)

    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.

Secondary outcomes

  1. Brief Pain Inventory

    Time frame: Baseline, weeks 1-4 before surgery, day of surgery (postoperative day 0), postoperative days 1-3, and postoperative days 30, 90, 180 and 365.

    Brief Pain Inventory is a validated pain assessment tool that measures pain severity and its effects on daily function.

  2. Clinical Opiate Withdrawal Scale

    Time frame: 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.

    Standardized assessment of opioid withdrawal

  3. Patient Health Questionnaire-9

    Time frame: Baseline, weeks 1-4 prior to surgery, and postoperative days 30, 90, 180, and 365

    Depression screening

  4. Generalized Anxiety Disorder-2

    Time frame: Baseline

    Standardized generalized anxiety screening

  5. Columbia Suicide Screening Assessment

    Time frame: Screening period

    This is a suicide risk screening tool

  6. Daily opioid use in hospital

    Time frame: Postoperative days 0-7

    This will be the average daily opioid use in the hospital

  7. Hospital length of stay

    Time frame: Postoperative days 0-7

    Duration of hospital stay in days

  8. Quality of recovery-15

    Time frame: Preoperative baseline, postoperative days 1-2

    This is a validated 15-question assessment of quality of recovery

  9. Hospital Anxiety and Depression Scale

    Time frame: Postoperative days 0-3

    Anxiety and depression assessment for the hospitalization

  10. Opioid use in daily OMEs

    Time frame: Day of surgery (postoperative day 0), postoperative days 30, 90, 180 and 365

    Patient-reported daily opioid use on average in mg

  11. Daily opioid use in OMEs from prescription drug monitoring program

    Time frame: Day of surgery (postoperative day 0), postoperative days 30, 90, 180, and 365

    This is the prescribed daily opioids confirmed from the PDMP.

  12. Nausea and vomiting

    Time frame: Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365

    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

  13. Constipation

    Time frame: Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365

    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

  14. Pruritus

    Time frame: Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365

    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

  15. Patient satisfaction with pain control

    Time frame: Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365

    0-10 scale with 0 being worst possible pain control and 10 being best possible pain control

  16. SF-12

    Time frame: Baseline, day of surgery (postoperative day 0), and postoperative days 30, 90, 180, and 365

    This is a brief assessment of physical and mental function

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 28, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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