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

Adjunctive Mindfulness During Opioid Tapering for Patients With Chronic Pain

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: Mindfulness-Oriented Recovery Enhancement: (MORE) group; Behavioral: Psychoeducation

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Psychoeducation	Behavioral: Psychoeducation; Education on the neurobiology of pain, healthy eating, diet, sleep and stress
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Interference	assessed by the Brief pain interventory	Baseline, 8 weeks, 3 month and 6 month follow up
Opioid Dose	assessed through their medical record	Baseline, 8 weeks, 3 month and 6 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	assessed through the Brief Pain Inventory	Baseline, 8 weeks, 3 month and 6 month follow up
Opioid Misuse	assessed by the Current Opioid Misuse Measure (COMM)	Baseline, 8 weeks, 3 month and 6 month follow up
Opioid Withdrawal	assessed by the Opioid Withdrawal Scale (SOWS)	Baseline, 8 weeks, 3 month and 6 month follow up
Opioid Craving	assessed by the single item Opioid Craving	Baseline,8 weeks, 3 month and 6 month follow up

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): June 28, 2025
• Study Completion (Actual): June 28, 2025

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain; Population Characteristics; Demography; Population Groups
• Other Study ID Numbers: 2023P001582

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not decided yet the IPD sharing plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No