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

Last updated: February 12, 2024
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Treatment

Mindfulness-Oriented Recovery Enhancement: (MORE) group

Psychoeducation

Clinical Study ID

NCT06268522
2023P001582
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • age>18yo
  • Chronic Low Back Pain as seen on medical history as well as score of >3 on pain visualanalog scale (VAS) at the start of experimental sessions.
  • receiving prescription opioids for three or more months and planning to start taperingtheir opioids with their provider.
  • willing to be randomized to one of the two behavioral treatment. Patients referred orself-referred to the study from an outside clinic will also be able to participate (wewill 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

Exclusion criteria:

  • Current illicit substance use (e.g marijuana use will be exempted) at screening orduring trial as verified by urine toxicology screen and/or self-report for allparticipants;
  • 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

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Mindfulness-Oriented Recovery Enhancement: (MORE) group
Phase:
Study Start date:
February 01, 2024
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • Brigham and Women's Hospital

    Chestnut Hill, Massachusetts 02467
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.