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

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

Conditions

• Chronic Pain
• Back Pain
• Neck Pain
• Opioid Misuse

Interventions

DRUG

Tizanidine

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

BEHAVIORAL

MI-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.

DRUG

Placebo

1 tablet three times a day for 5 weeks after surgery

BEHAVIORAL

Enhanced 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.

Sponsors & Collaborators

• Stanford University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-05

Primary Completion

2028-01-31

Completion

2028-07-31

FDA Drug

Yes

Countries

• United States

Study Locations