Actively Recruiting
CARES (Comprehensive Analgesic, Recovery, and Education Support) for Surgery Trial
Led by Stanford University · Updated on 2026-05-06
375
Participants Needed
4
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn whether a combined behavioral and pharmacologic intervention can help reduce opioid use, improve pain recovery, and prevent opioid misuse after surgery in adults undergoing elective surgery. The study includes adults aged 18 to 75 who have a history of long-term opioid use, defined as having access to opioids for 60 or more days within the 180 days before surgery. The main questions it aims to answer are: * Does Motivational Interviewing with guided opioid tapering plus tizanidine (MI-Opioid Taper + Tizanidine) help participants return to their preoperative opioid use level or stop opioids faster than Enhanced Usual Care (EUC)? * Does the intervention reduce the time to pain resolution and decrease the likelihood of opioid misuse after surgery compared to EUC? Researchers will compare MI-Opioid Taper + Tizanidine to MI-Opioid Taper with placebo and to EUC to see whether the intervention improves postoperative opioid and pain outcomes. Participants will: * Complete a phone assessment and baseline survey before surgery * Be randomly assigned 7-13 days after surgery to one of three groups: * MI-Opioid Taper + tizanidine (MTT) * MI-Opioid Taper + placebo (MTP) * Enhanced Usual Care (EUC) * Complete brief weekly phone or video visits with a study clinician for 6 weeks starting 14 days after surgery * Take a study medication (tizanidine or placebo) three times daily for 5 weeks (MTT and MTP groups only) * Complete weekly online surveys for 6 months, followed by monthly surveys until 12 months after surgery to track pain, opioid use, and related outcomes
CONDITIONS
Official Title
CARES (Comprehensive Analgesic, Recovery, and Education Support) for Surgery Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Able to speak, write, and read fluently in English
- Scheduled for elective surgery at Stanford University Medical Center, Brigham and Women's Hospital, Atrium Health Wake Forest Baptist Medical Center, or University of Kansas Medical Center
- History of long-term opioid use before surgery, defined as 60 or more days of opioid supply within 180 days before surgery
- Willing and able to complete online assessments and study calls independently
- On baseline assessment, meet at least one of the following: COMM-17 score 9 or higher, TAPS-1 reported use more frequent than "Never" (except tobacco with specific criteria), AUDIT-C score 4 or higher for men and 3 or higher for women, or positive responses on the modified Brief Pain Inventory related to pain medication use
- Postoperative opioid dose 7 to 13 days after surgery is equal to or greater than preoperative dose measured in Morphine Milligram Equivalents (MME)
You will not qualify if you...
- Infection, tumor, or fracture at surgical site
- Allergy or intolerance to tizanidine
- Current use of tizanidine
- Kidney problems with Creatinine Clearance less than 25 ml/min
- Liver problems including cirrhosis or high liver enzymes
- Use of other alpha-2 adrenergic agonists or muscle relaxants
- Use of certain medications including fluvoxamine, ciprofloxacin, zileuton, fluoroquinolones, some antiarrhythmics, cimetidine, famotidine, oral contraceptives, acyclovir, ticlopidine, and fexinidazole
- Low blood pressure, sedation, dizziness, or severe breathing problems
- Diagnosis of opioid use disorder
- Suicidal thoughts measured by PHQ-9 question 9 score of 1 or higher
- Pregnancy, breastfeeding, or planning to become pregnant
- Planned cancer treatment within 3 months after surgery
- Conditions preventing completion of assessments due to education, cognitive, mental, or medical status
- Participation in another clinical trial with an active treatment arm
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Trial Site Locations
Total: 4 locations
1
Stanford University Medical Center
Stanford, California, United States, 94305
Actively Recruiting
2
University of Kansas Medical Center
Kansas City, Kansas, United States, 66103
Actively Recruiting
3
Harvard University- Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
S
Shana C Levine, BA, CARES RESEARCH COORDINATOR
CONTACT
S
SPARKLE (Strategies for Pain Alleviation though Research and Knowledge for Long-term Efficacy) Lab
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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