Integrating Tailored Postoperative Opioid Tapering and Pain Management Support for Patients on Long-Term Opioid Use Presenting for Surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 375
- 试验地点
- 5
- 主要终点
- Time to baseline opioid use
研究概览
简要总结
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:
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Complete a phone assessment and baseline survey before surgery
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Be randomly assigned 7-13 days after surgery to one of three groups:
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MI-Opioid Taper + tizanidine (MTT)
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MI-Opioid Taper + placebo (MTP)
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Enhanced Usual Care (EUC)
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Complete brief weekly phone or video visits with a study clinician for 6 weeks starting 14 days after surgery
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Take a study medication (tizanidine or placebo) three times daily for 5 weeks (MTT and MTP groups only)
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Complete weekly online surveys for 6 months, followed by monthly surveys until 12 months after surgery to track pain, opioid use, and related outcomes
详细描述
This is a Type 1 hybrid effectiveness-implementation, three-arm, parallel randomized controlled trial (RCT) evaluating a behavioral-pharmacologic intervention for postoperative opioid management in patients with preoperative long-term opioid use (LTOU). A total of 375 participants will be enrolled across four academic medical centers:
- Stanford University Medical Center,
- Harvard University- Brigham and Women's Hospital,
- Wake Forest University- Atrium Health Wake Forest Baptist Medical Center, and
- University of Kansas Medical Center.
Eligible participants will be randomized in equal allocation to one of three study conditions:
- Motivational Interviewing-Guided Opioid Taper combined with tizanidine (MI-Opioid Taper + Tizanidine),
- MI-Opioid Taper with placebo, or
- Enhanced Usual Care (EUC). Participants will be followed for 12 months following surgery, with structured assessments of opioid use, pain outcomes, and related behavioral and clinical measures.
The primary endpoint is time to return to baseline opioid use. Secondary endpoints include time to opioid cessation, time to opioid dispensing cessation, time to pain cessation, and incidence of postoperative opioid misuse. Additional exploratory analyses will examine behavioral and clinical mediators of treatment effects, including motivation for change, change talk, and pain reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
MI-Opioid Taper and tizanidine
干预措施: Tizanidine (Drug)
MI-Opioid Taper and placebo
干预措施: Placebo (Drug)
MI-Opioid Taper and tizanidine
干预措施: MI-Opioid Taper (Behavioral)
MI-Opioid Taper and placebo
干预措施: MI-Opioid Taper (Behavioral)
Enhanced Usual Care
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Time to baseline opioid use
时间窗: 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.
Time to Baseline Opioid Use
时间窗: From Postoperative Day 7 through Postoperative Day 365
Defined as the first of two consecutive reports of return to preoperative daily MME or lower on the modified Brief Pain Inventory (mBPI) or the Recent Opioid Medication Use survey. Preoperative daily MME use is defined as average daily MME assessed during the Preoperative Call in the 1-5 day window prior to surgery.
次要结局
- Time to Complete Opioid Cessation(From Postoperative Day 7 through Postoperative Day 365)
- Time to Opioid Dispensing Cessation(From Postoperative Day 7 through Postoperative Day 365)
研究者
Jennifer Hah
Associate Professor
Stanford University