Adjunctive Mindfulness During Opioid Tapering for patientS With Chronic Pain (The AMOS Study) (NCT06268522) | Clinical Trial Compass
CompletedNot Applicable
Adjunctive Mindfulness During Opioid Tapering for patientS With Chronic Pain (The AMOS Study)
United States121 participantsStarted 2024-02-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Interference
Timeframe: Baseline, 8 weeks, 3 month and 6 month follow up
2
Opioid Dose
Timeframe: Baseline, 8 weeks, 3 month and 6 month follow up