Mindfulness support for reducing opioid use in chronic low back pain patients
Adjunctive Mindfulness During Opioid Tapering for Patients With Chronic Pain
NA · Brigham and Women's Hospital · NCT06268522
This study is testing if mindfulness practices can help people with chronic low back pain use less opioid medication while still managing their pain.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital (other) |
| Locations | 1 site (Chestnut Hill, Massachusetts) |
| Trial ID | NCT06268522 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of mindfulness interventions on reducing pain interference and opioid dosage in patients suffering from chronic low back pain. A total of 200 participants will be enrolled and randomly assigned to either a Mindfulness-Oriented Recovery Enhancement group or a Psychoeducation control group. The goal is to assess whether mindfulness can aid in the tapering of opioid medications while managing pain effectively.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with chronic low back pain who have been using prescription opioids for at least three months and are planning to taper their medication.
Not a fit: Patients currently using illicit substances or those with medical conditions that could interfere with participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help patients reduce their reliance on opioids while effectively managing their chronic pain.
How similar studies have performed: Other studies have shown promising results with mindfulness interventions in pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * age\>18yo * Chronic Low Back Pain as seen on medical history as well as score of \>3 on pain visual analog scale (VAS) at the start of experimental sessions. * receiving prescription opioids for three or more months and planning to start tapering their opioids with their provider. * willing to be randomized to one of the two behavioral treatment. Patients referred or self-referred to the study from an outside clinic will also be able to participate (we will be in contact with their prescribing provider) * able and willing to perform/tolerate pain procedures (e.g., QST) * able to communicate fluently in English * able to use a smartphone or laptop for the virtual therapy program Exclusion criteria: * Current illicit substance use (e.g marijuana use will be exempted) at screening or during trial as verified by urine toxicology screen and/or self-report for all participants; * Medical condition known to influence QST or participation in the MORE intervention; serious psychiatric condition; * regular meditation practice * cognitive impairment * pregnancy * lack of English fluency * severe OUD * inability to provide informed consent.
Where this trial is running
Chestnut Hill, Massachusetts
- Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Low Back Pain