- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06027099
CARES-Spine (Comprehensive Analgesic, Recovery, and Education Support for Spine Surgery) Trial
Integrating Tailored Postoperative Opioid Tapering and Pain Management Support for Patients on Long-Term Opioid Use Presenting for Spine Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Enhanced Usual Care
|
Participants will receive weekly phone calls from weeks 2 to 7, and at week 11. 1 topic per call will be reviewed in this sequence:1) standardized instructions on taking opioid medications after surgery, 2) safe opioid use, 3) avoiding medication errors, 4) local mental health resources and 988 Suicide & Crisis lifeline, 5) disposal of unused medications, 6) prescription drug abuse, and 7) complementary health approaches for chronic pain.
Education materials will be reviewed in a didactic style without a tailored discussion.
|
Experimental: MI-Opioid Taper and tizanidine
|
Tizanidine 2mg three times a day for 5 weeks after surgery
Motivational Interviewing (MI) and guided Opioid Tapering support adapting MI principles for enhancing motivation to change in pain treatment and tailoring key MI tools to postoperative opioid use delivered through weekly phone calls from weeks 2 to 7, and at week 11.
The guided opioid tapering protocol will be a 25% total daily opioid dose reduction every 7 days with opioid discontinuation 7 days after reaching 1 opioid pill per day.
|
Experimental: MI-Opioid Taper and placebo
|
Motivational Interviewing (MI) and guided Opioid Tapering support adapting MI principles for enhancing motivation to change in pain treatment and tailoring key MI tools to postoperative opioid use delivered through weekly phone calls from weeks 2 to 7, and at week 11.
The guided opioid tapering protocol will be a 25% total daily opioid dose reduction every 7 days with opioid discontinuation 7 days after reaching 1 opioid pill per day.
1 tablet three times a day for 5 weeks after surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to baseline opioid use
Time Frame: Assessed after surgery up to 1 year after surgery
|
Defined as the 1st of 2 consecutive reports of return to preoperative daily OME use or lower on the modified BPI.Preoperative daily OME use is defined as average daily OME assessed over 3 days, on days 7 to 9 before surgery.
|
Assessed after surgery up to 1 year after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Pain
- Neurologic Manifestations
- Narcotic-Related Disorders
- Chronic Pain
- Neck Pain
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Anticonvulsants
- Neuromuscular Agents
- Muscle Relaxants, Central
- Tizanidine
Other Study ID Numbers
- 71909
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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