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

Purpose

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.

Condition

  • Low Back Pain

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Behavioral
Primary Purpose
Treatment
Masking
Triple (Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mindfulness-Oriented Recovery Enhancement: (MORE) group
  • Behavioral: Mindfulness-Oriented Recovery Enhancement: (MORE) group
    Mindfulness-Oriented Recovery Enhancement (MORE) is a novel social work intervention and mental training program that unites complementary aspects of mindfulness training.
Placebo Comparator
Psychoeducation
  • Behavioral: Psychoeducation
    Education on the neurobiology of pain, healthy eating, diet, sleep and stress

Recruiting Locations

Brigham and Women's Hospital
Chestnut Hill, Massachusetts 02467
Contact:
Marie Curiel
617-732-9578
MCURIEL@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact