RecruitingPhase 3

CARES (Comprehensive Analgesic, Recovery, and Education Support) for Surgery Trial

United States375 participantsStarted 2024-12-05

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 med…

What they're measuring

Time to Baseline Opioid Use

Timeframe: From Postoperative Day 7 through Postoperative Day 365

Trial details

NCT IDNCT06027099

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01

Contact for this trial

Shana C Levine, BA, CARES RESEARCH COORDINATOR

650-649-9618 Shana8@stanford.edu