Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06027099 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: CARES
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 1 to 4v5 Show 5 more changesShow less
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints expanded, about 10 words
    • Primary endpoint revised
    • Study description expanded, about 94 words
    • Study title shortened, about 1 word
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2024 to Dec 5, 2024
    v4
  3. Start date: Feb 2024 to Sep 2024v3
  4. Study description expanded, about 157 words
    • Study title shortened, about 8 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06027099
Lead Sponsor Stanford University
Conditions
(from sponsor)		 Chronic Pain, Back Pain, Neck Pain, Opioid Misuse
Related terms Back Pain, Chronic Pain, Neck Pain, Opioid-Related Disorders
Enrollment 375 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov