Adjunctive Mindfulness During Opioid Tapering for patientS With Chronic Pain (The AMOS Study)
Completed · Not applicable
Conditions studied: Low Back Pain
In brief
This study is a Randomized Controlled Trial exploring the effects of a Mindfulness interventions in reducing pain interference and opioid dose in patients with Chronic Low Back Pain. A total of 200 opioid-using patients with chronic pain, male and female participants will be enrolled, with a need for 160 completers. Patient will be randomly assigned into the Mindfulness-Oriented Recovery Enhancement or the Psychoeducation comparison control group.
Key facts
- Study ID
- NCT06268522
- Run by
- Brigham and Women's Hospital
- People needed
- 121
- Starts
- 2024-02-01
- Expected to finish
- 2025-06-28
- Last updated by the study team
- 2026-01-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States
Full record on ClinicalTrials.gov
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