What this study is
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 placebo and to EUC to see whether the intervention improves postoperative opioid and pain outcomes.
Participants will:
- Complete a phone assessment and baseline survey before surgery
- Be randomly assigned 7-13 days after surgery to one of three groups:
- MI-Opioid Taper + tizanidine (MTT)
- MI-Opioid Taper + placebo (MTP)
- Enhanced Usual Care (EUC)
- Complete brief weekly phone or video visits with a study clinician for 6 weeks starting 14 days after surgery
- Take a study medication (tizanidine or placebo) three times daily for 5 weeks (MTT and MTP groups only)
- Complete weekly online surveys for 6 months, followed by monthly surveys until 12 months after surgery to track pain, opioid use, and related outcomes
What's being tested
- Tizanidine
Intervention · DRUG
Tizanidine 2mg three times a day for 5 weeks after surgery
- MI-Opioid Taper
Intervention · BEHAVIORAL
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.
- Placebo
Intervention · DRUG
1 tablet three times a day for 5 weeks after surgery
- Enhanced Usual Care
Intervention · BEHAVIORAL
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.
Study details
- Official title
- Integrating Tailored Postoperative Opioid Tapering and Pain Management Support for Patients on Long-Term Opioid Use Presenting for Surgery
- Sponsor
- Stanford University
- Conditions
- Chronic Pain · Back Pain · Neck Pain · Opioid Misuse
- Enrolling
- 375 people
- Starts
- 2024-12-05
- Est. completion
- 2028-07
- Design
- Quadruple-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify 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),; 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).
You 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
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (4)
4 openStanford University Medical Center
Stanford, California, United States
- Jennifer M Hah, MD, MS · Contact650-724-3193jhah@stanford.edu
- Shana C Levine, BA · Contact650-649-9618shana8@stanford.edu
- Jennifer M Hah, MD, MS · Principal investigator
RecruitingUniversity of Kansas Medical Center
Kansas City, Kansas, United States
- Andrea Chadwick, MD, MSc, FASA · Contact913-588-3479anicol@kumc.edu
- FACE (Fibromyalgia And Centralized pain Exploration) Lab · Contact913-588-7630facelab@kumc.edu
- Andrea Chadwick, MD · Principal investigator
RecruitingHarvard University- Brigham and Women's Hospital
Boston, Massachusetts, United States
- Samantha Meints, PhD (PRINCIPAL INVESTIGATOR) · Contact612-205-0186smeints@bwh.harvard.edu
- Caroline Allen, BS · Contact617-732-9014callen22@bwh.harvard.edu
- Samantha Meints, PhD · Principal investigator
- Jenna Wilson, PhD · Sub-investigator
RecruitingAtrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
- Robert Hurley, MD, PhD, FASA · Contact336-716-1228Robert.Hurley@Advocatehealth.org
- Lynnette Harris, RN, BSN · Contact336-716-8791Lynnette.Harris@advocatehealth.org
- Robert Hurley, MD, PhD, FASA · Principal investigator
Recruiting
Study team
Sponsor
Stanford University
Study ID 71909
CONTACT
SPARKLE (Strategies for Pain Alleviation though Research and Knowledge for Long-term Efficacy) Lab
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.