Actively Recruiting
Integrating Tailored Postoperative Opioid Tapering and Pain Management Support for Patients on Long-Term Opioid Use Presenting for Surgery
Led by Stanford University · Updated on 2026-05-06
375
Participants Needed
4
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults aged 18 to 75 who have a history of long-term opioid use to see if a combined behavioral and drug treatment can reduce opioid use, improve pain recovery, and prevent opioid misuse after elective surgery. This clinical trial compares Motivational Interviewing with guided opioid tapering plus tizanidine against Motivational Interviewing with placebo and Enhanced Usual Care to understand which approach best helps patients return to their preoperative opioid use level or stop opioids faster. The study addresses an important need for better postoperative pain care for patients already using opioids long term. The trial has three groups: one receiving Motivational Interviewing-guided opioid tapering with tizanidine; another receiving the same counseling with placebo; and a control group receiving Enhanced Usual Care focused on education about opioid use and pain management. Participants take the study medication (tizanidine or placebo) three times daily for five weeks if in the drug groups. Weekly phone or video visits with clinicians occur for six weeks starting two weeks after surgery, plus an additional follow-up call at week 11. Participants complete a phone assessment and baseline survey before surgery, then weekly online surveys for six months and monthly surveys up to one year after surgery to track opioid use, pain, and related outcomes. Researchers monitor time to return to baseline opioid use as the main outcome, along with opioid cessation, pain resolution, and opioid misuse. The study includes detailed assessments and follow-up over 12 months to understand how these interventions work and their potential for wider use.
CONDITIONS
Brief 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 one of the four specified medical centers
- History of preoperative long-term opioid use, defined as 60 or more days of opioid supply in the 180 days before surgery
- Willing and able to complete online assessments and study calls independently
- At least one of the following on baseline assessments: high score on opioid misuse measure, substance use reported on TAPS, elevated alcohol use on AUDIT-C, specific responses on pain inventory
- Postoperative opioid dose 7-13 days after surgery equal to or greater than preoperative dose
You will not qualify if you...
- Infection, tumor, or fracture at the surgery site
- Allergy or intolerance to tizanidine
- Current use of tizanidine
- Severe kidney impairment (Creatinine Clearance less than 25 ml/min)
- Liver problems including cirrhosis or elevated liver enzymes
- Concurrent use of certain medications like other muscle relaxants or specific antibiotics
- Pre-existing low blood pressure, sedation, dizziness, or severe breathing problems
- Diagnosed opioid use disorder
- Suicidal thoughts as indicated by a questionnaire
- Pregnancy, breastfeeding, or planning to conceive
- Planned cancer treatment within 3 months after surgery
- Conditions preventing completion of study assessments
- Participation in another clinical trial with an active treatment arm
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants receive tailored postoperative opioid tapering and pain management support through medication and behavioral interventions after surgery.
Weekly phone calls from weeks 2 to 7 and one phone call at week 11
Duration - 12 months
Participants are followed for 12 months after surgery with structured assessments of opioid use, pain outcomes, and related behavioral and clinical measures.
Structured assessments at multiple time points during the 12 months
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
S
SPARKLE (Strategies for Pain Alleviation though Research and Knowledge for Long-term Efficacy) Lab
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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