Chronic Pain study: Tizanidine vs MI-Opioid Taper
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, 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
- This study aims to find out if combining talk therapy, a gradual reduction in pain medication, and a muscle relaxer helps people use fewer opioids and recover from pain faster after surgery.
- Who it's for
- The study is looking for adults aged 18 to 75 who are scheduled for elective surgery and have been using opioids for at least 60 days in the past six months.
- What's involved
- Participants will take a daily pill (either a muscle relaxer or a sugar pill) for five weeks and have brief weekly phone or video check-ins with a study clinician for six weeks. They will also complete online surveys about their pain and medication use for one year.
- Time commitment
- The study involves weekly visits for six weeks and online surveys for 12 months after 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
- 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)
- 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 is enrolling
- 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, but 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?
This study is enrolling now at 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 enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.