๐ฌIn plain words
What the trial is, and whether it could suit you
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 plac
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ 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 โฅ 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 โฅ4 (men), โฅ3 (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 โฅ 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 ฮฑ2-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 โฅ 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
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