Recruiting

Opioid Tapering with CBT

Sponsor:

Thomas Jefferson University

Code:

NCT07221786

Conditions

Opioid Consumption, Postoperative

Pain After Surgery

Opioid Dependency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Opioid tapering with CBT and education

Opioid tapering with education alone

Study Details

Brief summary:

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.

Conditions

Opioid Consumption, Postoperative

Pain After Surgery

Opioid Dependency

Study ID

NCT07221786

Start date

Dec 1, 2025

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • proportion that achieved opioid tapering goal [ Time Frame: Perioperative prior to surgery (postoperative day 0) ]

Central Contacts and Locations

Central contacts

Eric Schwenk, MD

267-239-3319eric.schwenk@jefferson.edu

Jeffrey Mojica, DO

jeffrey.mojica@jefferson.edu

Locations

Thomas Jefferson University Hospital

Recruiting

Philadephia, Pennsylvania, United States, 19107

Contacts

Eric Schwenk, MD

919-360-0762eric.schwenk@jefferson.edu

Jeffrey Mojica, DO

856-979-1643jeffrey.mojica@jefferson.edu

Principal Investigator:

Eric Schwenk, MD

More Information

Sponsor

Thomas Jefferson University

Last update posted

Mar 24, 2026

Last verified

Jan, 2026

Keywords

  • spine surgery
  • pain management
  • opioids
  • opioid use
  • depression
  • anxiety
  • opioid dependence
  • opioid tapering
  • cognitive behavioral therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-03-24.