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New treatment option for Chronic Pain
Official title CARES (Comprehensive Analgesic, Recovery, and Education Support) for Surgery Trial
ClinicalTrials.gov ID: NCT06027099
What this study is testing
What is Tizanidine?
Tizanidine is an investigational medicine, given as an once-weekly, being studied as a potential treatment for chronic pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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),
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Kansas City, Kansas, United States
- Boston, Massachusetts, United States
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States; Kansas City, Kansas, United States; Boston, Massachusetts, United States; Winston-Salem, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.