CARES (Comprehensive Analgesic, Recovery, and Education Support) for Surgery Trial

NCT ID
NCT06027099
Registry status
Recruiting
Study type
Interventional
Phase
Phase 3
Sponsor
Stanford University
Conditions
Back Pain, Chronic Pain, Neck Pain, Opioid Misuse

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Integrating Tailored Postoperative Opioid Tapering and Pain Management Support for Patients on Long-Term Opioid Use Presenting for Surgery

Enrollment: 375 participants (Estimated).

What is being studied

  • Behavioral: Enhanced Usual Care
  • Behavioral: MI-Opioid Taper
  • Drug: Placebo
  • Intervention: tizanidine
  • Drug: Tizanidine

Who may be eligible

Ages
18 Years to 75 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

INCLUSION CRITERIA: * 18 to 75 years of age * Able to speak, write, and read fluently in English * Scheduled for elective surgery at * Stanford University Medical Center, * Brigham and Women's Hospital (Harvard University), * Atrium Health Wake Forest Baptist Medical Center (Wake Forest University), or * University of Kansas Medical Center * Preoperative long-term opioid use (Defined as ≥ 60-day supply of opioids in the 180-day period prior to surgery), identified via self-report, state Prescription Drug Monitoring Program (PDMP), or Electronic Medical Records (EHR). Days may be nonconsecutive, and actual use of opioid supply is not required. * Willing and able to complete online assessments and study calls independently * On the preoperative Baseline assessments, least one of the following: * Current Opioid Misuse Measure (COMM-17): score ≥ 9 * Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1): Reported use more frequent than "Never" on any item except Tobacco; for Tobacco, "Yes" to at least one item on the TAPS-2 for Tobacco * Alcohol Use Disorders Identification Test (AUDIT-C): score ≥4 (men), ≥3 (women) * Modified Brief Pain Inventory (mBPI): "Yes" to at least one of the following: * Over the past 24 hours have you needed to take your pain medication to help you sleep? * Have you taken any pain medications for any reason other than your pain, such as to reduce anxiety or improve mood? * Have you taken more pain medication than was prescribed to you in the past 24 hours? * At the Post-Operative Call (7-13 days post-op): Postoperative daily opioid dose ≥ preoperative daily opioid dose (identified during the Pre-Surgery Call 5-1 day before surgery), measured in Morphine Milligram Equivalents (MME). EXCLUSION CRITERIA * Infection, tumor, or fracture at the operative site * Allergy or intolerance to tizanidine * Current use of tizanidine * Renal impairment (Creatinine Clearance \[CrCl\] \< 25 ml/min) * Hepatic impairment, including cirrhosis or elevated liver enzymes * Concurrent use of other α2-adrenergic agonists, skeletal muscle relaxants * Concurrent use of: fluvoxamine, ciprofloxacin,zileuton, fluoroquinolones, antiarrhythmics (amiodarone, mexiletine, propafenone, verapamil), cimetidine, famotidine, oral contraceptive pills, acyclovir, ticlopidine, and fexinidazole * Pre-existing hypotension, sedation, dizziness, severe respiratory insufficiency. * Opioid Use Disorder * Suicidality as assessed by the Patient Health Questionnaire-9 (PHQ-9) Question 9 score ≥ 1 * Pregnancy, breastfeeding, or planning to conceive * Planned cancer treatment in the \< 3 months following surgery * Conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status) * Participating in another clinical trial with an active treatment arm

Study locations

4 study locations are listed.

Recruiting site status is explicitly provided for 4 locations; 4 are listed as Recruiting.

Countries: United States

  • California, United States: 1
  • Kansas, United States: 1
  • Massachusetts, United States: 1
  • North Carolina, United States: 1

Sample of listed locations

  • Stanford University Medical Center — Stanford, California, 94305, United States — Recruiting
  • University of Kansas Medical Center — Kansas City, Kansas, 66103, United States — Recruiting
  • Harvard University- Brigham and Women's Hospital — Boston, Massachusetts, 02115, United States — Recruiting
  • Atrium Health Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, 27157, United States — Recruiting

Study details

Start date
December 5, 2024
Primary completion date
January 1, 2028
Completion date
July 1, 2028
First posted
September 7, 2023

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06027099
Registry last updated
May 6, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT06027099 on ClinicalTrials.gov

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