RecruitingPhase 3NCT06027099

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

Integrating Tailored Postoperative Opioid Tapering and Pain Management Support for Patients on Long-Term Opioid Use Presenting for Surgery

Sponsor

Stanford University

Enrollment

375 participants

Start Date

Dec 5, 2024

Study Type

INTERVENTIONAL

Conditions

Opioid misuse Chronic Pain Back Pain Neck Pain

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Enhanced Usual Care, a behavioral approach called MI-Opioid Taper, and others for people with back pain, chronic pain, and other related conditions. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTizanidine

Tizanidine 2mg three times a day for 5 weeks after surgery

BEHAVIORALMI-Opioid Taper

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.

DRUGPlacebo

1 tablet three times a day for 5 weeks after surgery

BEHAVIORALEnhanced Usual Care

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.