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NCT06027099 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Chronic Pain and Back Pain, sponsored by Stanford University.

Recruiting
Registry status
Phase 3
Development phase
375
Enrollment target
1
Study location

NCT06027099: Recruiting Phase 3 study of Chronic Pain and Back Pain, sponsored by Stanford University.

NCT06027099 is a Phase 3 study of Chronic Pain and Back Pain that is actively recruiting participants, run by Stanford University. The registered enrollment target is 375 participants, below the 771-participant average among 301 other Chronic Pain trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06027099, a Phase 3 study of Chronic Pain and Back Pain, is actively recruiting participants, sponsored by Stanford University.

RECRUITING
Registry status
Phase 3
Development phase
375 participants
Enrollment target
1
Study location

Study Summary

Three-arm randomized controlled trial, of Motivational Interviewing and guided Opioid Tapering support (MI-Opioid Taper) and tizanidine vs. MI-Opioid Taper and placebo vs. enhanced usual care to promote postoperative opioid cessation and pain cessation and reduce the incidence of postoperative opioid misuse among patients undergoing spine surgery.

Primary Outcome

Defined as the first of two consecutive reports of return to preoperative daily MME or lower on the modified Brief Pain Inventory (mBPI) or the Recent Opioid Medication Use survey. Preoperative daily MME use is defined as average daily MME assessed during the Preoperative Call in the 1-5 day window prior to surgery.

Interventions

  • DRUG Placebo
  • BEHAVIORAL Enhanced Usual Care
  • DRUG Tizanidine
  • BEHAVIORAL MI-Opioid Taper

Study Locations (1)

California

  • Stanford University Hospital - Stanford

Trial Details

FieldValue
Enrollment Target 375 participants
Start Date 2024-12-05
Est. Completion 2028-07
Phase Phase 3
Stanford University

1,744 total trials

What NCT06027099 shows while recruiting

NCT06027099 is an interventional study that assigns participants to a tested intervention. The registered 375 participants enrollment target is mid-sized for trials with a published cap, below the 771-participant average among 301 other Chronic Pain trials with a reported enrollment target (51% lower).

The record links to 4 conditions, with Chronic Pain appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT06027099 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT06027099 about?

NCT06027099 is a clinical study titled "CARES-Spine (Comprehensive Analgesic, Recovery, and Education Support for Spine Surgery) Trial". Three-arm randomized controlled trial, of Motivational Interviewing and guided Opioid Tapering support (MI-Opioid Taper) and tizanidine vs. MI-Opioid Taper and placebo vs. enhanced usual care to promote postoperative opioid cessation and pain cessation and reduce the incidence of postoperative opioi...

What is the current status of trial NCT06027099?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 375 participants. The study started on 2024-12-05. Estimated completion is 2028-07.

What conditions does trial NCT06027099 study?

This clinical trial studies the following conditions: Chronic Pain, Back Pain, Neck Pain, Opioid Misuse.

What interventions are being tested in trial NCT06027099?

The interventions under investigation include: Placebo (DRUG), Enhanced Usual Care (BEHAVIORAL), Tizanidine (DRUG), MI-Opioid Taper (BEHAVIORAL).

Who is sponsoring clinical trial NCT06027099?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06027099 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Chronic Pain

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06027099's enrollment target sits among peer trials

375 38th of 301 higher than 264 of 301 other Chronic Pain trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Chronic Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06027099, the US trial registry maintained by the National Library of Medicine. NCT06027099 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.