An interventional study of Opioid tapering with CBT and education and Opioid tapering with education alone in Opioid Consumption, Postoperative, Pain After Surgery and Opioid Dependency, sponsored by Thomas Jefferson University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Thomas Jefferson University · Not applicable, Interventional, and Treatment
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.
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.
1,190 studies on the registry are indexed under Agnosia; 507 are open to participants now.
This study's planned enrollment of 45 is below the median of 77 across 1,023 interventional studies indexed under Agnosia.
Browse Agnosia studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
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Exclusion:
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
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 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.
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.
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.
Time frame: Perioperative prior to surgery (postoperative day 0)
Brief Pain Inventory
Brief Pain Inventory is a validated pain assessment tool that measures pain severity and its effects on daily function.
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.
Clinical Opiate Withdrawal Scale
Standardized assessment of opioid withdrawal
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.
Patient Health Questionnaire-9
Depression screening
Time frame: Baseline, weeks 1-4 prior to surgery, and postoperative days 30, 90, 180, and 365
Generalized Anxiety Disorder-2
Standardized generalized anxiety screening
Time frame: Baseline
Columbia Suicide Screening Assessment
This is a suicide risk screening tool
Time frame: Screening period
Daily opioid use in hospital
This will be the average daily opioid use in the hospital
Time frame: Postoperative days 0-7
Hospital length of stay
Duration of hospital stay in days
Time frame: Postoperative days 0-7
Quality of recovery-15
This is a validated 15-question assessment of quality of recovery
Time frame: Preoperative baseline, postoperative days 1-2
Hospital Anxiety and Depression Scale
Anxiety and depression assessment for the hospitalization
Time frame: Postoperative days 0-3
Opioid use in daily OMEs
Patient-reported daily opioid use on average in mg
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365
SF-12
This is a brief assessment of physical and mental function
Time frame: Baseline, day of surgery (postoperative day 0), and postoperative days 30, 90, 180, and 365
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