Adjunctive Mindfulness During Opioid Tapering for patientS With Chronic Pain (The AMOS Study)

Mass General Brigham

Status

Completed

Conditions

Low Back Pain

Treatments

Behavioral: Psychoeducation

Behavioral: Mindfulness-Oriented Recovery Enhancement: (MORE) group

Study type

Interventional

Funder types

Other

Identifiers

NCT06268522

2023P001582

Details and patient eligibility

About

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.

Enrollment

121 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.