Tizanidine and MI-Opioid Taper for Opioid Dependence

This trial explores different methods to help patients stop using opioids after spine surgery. It tests three approaches: usual care, a combination of motivational support and tizanidine (a muscle relaxant), and motivational support with a placebo (a pill with no active medication). The goal is to determine which method best aids patients in quitting opioids and managing pain without misuse. Patients who have used opioids for at least three months before surgery and are scheduled for elective spine surgery for specific back problems might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

The trial does not specify if you must stop all current medications, but you cannot take certain drugs like tizanidine, fluvoxamine, or ciprofloxacin. If you're on these or similar medications, you may need to stop them to participate.

Research has shown that tizanidine is generally safe for use. As a muscle relaxant, it helps alleviate muscle tightness. Its long history of use supports its well-known safety profile. Common side effects include sleepiness, dry mouth, and dizziness, which are usually mild and manageable.

The MI-Opioid Taper approach has been studied as a method for safely reducing opioid use over time. This approach aims to lessen withdrawal symptoms and ease the process of stopping opioid use. Although tapering can sometimes cause discomfort, it is considered a safe and effective way to reduce dependence.

Researchers are excited about exploring new ways to address opioid dependence using a combination of techniques. Unlike the standard of care, which often involves opioid replacement therapy with medications like methadone or buprenorphine, these investigational treatments use a combination of an MI-Opioid taper and tizanidine. Tizanidine, a muscle relaxant, is being investigated for its potential to ease withdrawal symptoms, making the tapering process more manageable for patients. By targeting withdrawal symptoms directly, this approach could offer a smoother transition away from opioids, potentially reducing dependency with fewer side effects. This innovative combination could represent a significant advancement in the treatment of opioid dependence.

Research has shown that gradually reducing opioid use can help patients safely decrease their dependence. This method involves slowly lowering the opioid dose over time, usually by 5% to 20% every four weeks, reducing the risk of withdrawal symptoms. In this trial, participants may receive MI-Opioid Taper combined with tizanidine, a muscle relaxant that may ease withdrawal symptoms. Although little direct evidence links tizanidine to stopping opioid use, it is used to reduce muscle spasms and pain, which can help manage discomfort during tapering. Another group in this trial will receive MI-Opioid Taper with a placebo. Additionally, motivational interviewing, a type of counseling, supports behavior change by helping people find personal reasons to quit opioids. Together, these methods aim to help people stop using opioids while managing pain effectively.²³⁵⁶⁷