CARES-Spine (Comprehensive Analgesic, Recovery, and Education Support for Spine Surgery) Trial
Launched by STANFORD UNIVERSITY · Aug 30, 2023
Trial Information
Current as of July 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The CARES-Spine Trial is a research study aimed at helping patients who are having spine surgery and are dealing with chronic pain or have a history of opioid misuse. It will test two different approaches: one group will receive a special support program that includes motivational interviewing and help with reducing opioid use, along with a medication called tizanidine; another group will receive the same support but with a placebo (a non-active treatment); and the third group will get regular care. The goal is to see if these approaches can help patients stop using opioids after surgery while also managing their pain effectively.
To participate in this study, you need to be between 18 and 64 years old and scheduled for elective spine surgery, such as for a herniated disc or spinal stenosis. You should also have been using opioids for at least 90 days before your surgery and might have some concerns about how you use them. If you join, you can expect to receive support and education about pain management and opioid use, and you will complete some online assessments to track your progress. It’s important to know that certain conditions, like having an active infection or being pregnant, would make you ineligible for this trial.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adults aged 18-64 scheduled for elective spine surgery for lumbar or cervical degenerative disease (e.g. lumbar or cervical disc herniation, lumbar or cervical spinal stenosis, lumbar or cervical degenerative spondylolisthesis, lumbar or cervical disc degeneration, or degenerative cervical myelopathy including cervical spondylotic myelopathy).
- • Preoperative long-term opioid use (Defined as ≥ 90-day duration of use in the 4 months preceding surgery either via self-report or state PDMP.
- * Participants must report at least one of the following on preoperative assessments:
- • Current Opioid Misuse Measure (COMM) score greater than or equal to 9 Answering "Yes" to any of the following items on the modified Brief Pain Inventory (BPI)1) Over the past 24 hours have you needed to take your pain medication to help you sleep; 2)Have you taken any pain medications for any reason other than your pain, such as to reduce anxiety or improve mood? 3) Have you taken more pain medication than was prescribed to you in the past 24 hours? Score of greater than or equal to 2 on any Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1) item Positive Alcohol Use Disorders Identification Test (AUDIT-C) score (greater than or equal to 4 for men, greater than or equal to 3 for women)
- • Elevated opioid use 14 days after surgery compared to baseline daily OME Defined as average daily OME assessed over 3 days 1 week before surgery compared to average daily OME reported on postoperative days 12 to 14 to account for as-needed dosing and day-to-day variations in opioid use.
- • English-speaking
- • Ability and willingness to complete online assessments
- Exclusion Criteria:
- • Infection, tumor, or fracture at the operative site
- • Allergy or intolerance to tizanidine
- • Current use of tizanidine
- • Renal impairment
- • Hepatic impairment including cirrhosis or elevated 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
- • Cancer diagnosis, active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome
- • Conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)
- • Participating in another clinical trial with an active treatment arm
About Stanford University
Stanford University is a prestigious academic institution renowned for its cutting-edge research and innovation in healthcare and medicine. As a clinical trial sponsor, Stanford leverages its extensive resources, including a collaborative network of world-class researchers and state-of-the-art facilities, to advance medical knowledge and improve patient care. The university is committed to conducting rigorous, ethical research that adheres to the highest standards of scientific integrity, fostering an environment where groundbreaking discoveries can translate into effective clinical applications. Through its clinical trials, Stanford aims to address critical health challenges and contribute to the development of novel therapies and treatment strategies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported