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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT06027099
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tizanidine — DRUG
    Tizanidine 2mg three times a day for 5 weeks after surgery
  • MI-Opioid Taper — 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 — DRUG
    1 tablet three times a day for 5 weeks after surgery
  • Enhanced Usual Care — 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

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

Key Dates

Start date
Dec 5, 2024
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
375 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MI-Opioid Taper and tizanidine
  • Experimental: MI-Opioid Taper and placebo
  • Active Comparator: Enhanced Usual Care

Primary Outcome Measure

Time to Baseline Opioid Use [ Time Frame: From Postoperative Day 7 through Postoperative Day 365 ]

Central Contacts

  • Shana C Levine, BA, CARES RESEARCH COORDINATOR
    650-649-9618
    [email protected]
  • SPARKLE (Strategies for Pain Alleviation though Research and Knowledge for Long-term Efficacy) Lab
    [email protected]

Locations (4)

FacilityCityStateZIPSite coordinators
Stanford University Medical CenterStanfordCalifornia94305
Jennifer M Hah, MD, MS
[email protected]
650-724-3193
Shana C Levine, BA
[email protected]
650-649-9618
Jennifer M Hah, MD, MS (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical CenterKansas CityKansas66103
Andrea Chadwick, MD, MSc, FASA
[email protected]
913-588-3479
FACE (Fibromyalgia And Centralized pain Exploration) Lab
[email protected]
913-588-7630
Andrea Chadwick, MD (PRINCIPAL_INVESTIGATOR)
Harvard University- Brigham and Women's HospitalBostonMassachusetts02115
Samantha Meints, PhD (PRINCIPAL INVESTIGATOR)
[email protected]
612-205-0186
Caroline Allen, BS
[email protected]
617-732-9014
Samantha Meints, PhD (PRINCIPAL_INVESTIGATOR)
Jenna Wilson, PhD (SUB_INVESTIGATOR)
Atrium Health Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157
Robert Hurley, MD, PhD, FASA
[email protected]
336-716-1228
Lynnette Harris, RN, BSN
[email protected]
336-716-8791
Robert Hurley, MD, PhD, FASA (PRINCIPAL_INVESTIGATOR)

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