NCT06027099 CARES (Comprehensive Analgesic, Recovery, and Education Support) for Surgery Trial
| NCT ID | NCT06027099 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Stanford University |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 375 participants |
| Start Date | 2024-12-05 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 375 participants in total. It began in 2024-12-05 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06027099 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06027099 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 375 participants.
Is NCT06027099 currently recruiting?
Yes, NCT06027099 is actively recruiting participants. Contact the research team at Shana8@stanford.edu for enrollment information.
Where is the NCT06027099 trial being conducted?
This trial is being conducted at Stanford, United States, Kansas City, United States, Boston, United States, Winston-Salem, United States.
Who is sponsoring the NCT06027099 clinical trial?
NCT06027099 is sponsored by Stanford University. The trial plans to enroll 375 participants.
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