New combo therapy aims to wean surgery patients off opioids faster
NCT ID NCT06027099
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether counseling plus a muscle relaxant (tizanidine) can help adults who have used opioids for a long time reduce their pain medication after elective surgery. About 375 participants will be randomly assigned to one of three groups: the combo treatment, counseling plus a placebo, or standard care. The goal is to see if the intervention helps people return to their pre-surgery opioid level or stop opioids sooner, while also improving pain recovery and reducing misuse over 12 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 375 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 ≥ 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 ≥ 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 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 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 * 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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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Atrium Health Wake Forest Baptist Medical Center
RECRUITINGWinston-Salem, North Carolina, 27157, United States
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Harvard University- Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Stanford University Medical Center
RECRUITINGStanford, California, 94305, United States
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University of Kansas Medical Center
RECRUITINGKansas City, Kansas, 66103, United States
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