NCT06268522

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2025

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

February 2, 2024

Last Update Submit

January 28, 2026

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Pain Intensity

    Baseline, 8 weeks, 3 month and 6 month follow up

  • Opioid Misuse

    Baseline, 8 weeks, 3 month and 6 month follow up

  • Opioid Withdrawal

    Baseline, 8 weeks, 3 month and 6 month follow up

  • Opioid Craving

    Baseline,8 weeks, 3 month and 6 month follow up

Study Arms (2)

Mindfulness-Oriented Recovery Enhancement: (MORE) group

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

Psychoeducation

PLACEBO COMPARATOR
Behavioral: Psychoeducation

Interventions

PsychoeducationBEHAVIORAL

Education on the neurobiology of pain, healthy eating, diet, sleep and stress

Psychoeducation
Mindfulness-Oriented Recovery Enhancement: (MORE) groupBEHAVIORAL

Mindfulness-Oriented Recovery Enhancement (MORE) is a novel social work intervention and mental training program that unites complementary aspects of mindfulness training.

Mindfulness-Oriented Recovery Enhancement: (MORE) group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Behavioral
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

February 2, 2024

First Posted

February 20, 2024

Study Start

February 1, 2024

Primary Completion

June 28, 2025

Study Completion

June 28, 2025

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations

US(1)