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Phase 3
Age: 18Years - 75Years
All Genders
ID06027099

Study of Combined Behavioral and Medication Support to Reduce Opioid Use and Improve Pain Recovery After Surgery in Adults with Long-Term Opioid Use

Led by Stanford University · Updated on 2026-05-06

375

Participants Needed

4

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying adults aged 18 to 75 who have a history of long-term opioid use to see if a combined behavioral and drug treatment can reduce opioid use, improve pain recovery, and prevent opioid misuse after elective surgery. This clinical trial compares Motivational Interviewing with guided opioid tapering plus tizanidine against Motivational Interviewing with placebo and Enhanced Usual Care to understand which approach best helps patients return to their preoperative opioid use level or stop opioids faster. The study addresses an important need for better postoperative pain care for patients already using opioids long term. The trial has three groups one receiving Motivational Interviewing-guided opioid tapering with tizanidine another receiving the same counseling with placebo and a control group receiving Enhanced Usual Care focused on education about opioid use and pain management. Participants take the study medication tizanidine or placebo three times daily for five weeks if in the drug groups. Weekly phone or video visits with clinicians occur for six weeks starting two weeks after surgery, plus an additional follow-up call at week 11. Participants complete a phone assessment and baseline survey before surgery, then weekly online surveys for six months and monthly surveys up to one year after surgery to track opioid use, pain, and related outcomes. Researchers monitor time to return to baseline opioid use as the main outcome, along with opioid cessation, pain resolution, and opioid misuse. The study includes detailed assessments and follow-up over 12 months to understand how these interventions work and their potential for wider use.

CONDITIONS

Brief Title

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

Research Team

S

Shana C Levine, BA, CARES RESEARCH COORDINATOR

S

SPARKLE (Strategies for Pain Alleviation though Research and Knowledge for Long-term Efficacy) Lab

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