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

NCT ID: NCT06268522

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Behavioral
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Mindfulness-Oriented Recovery Enhancement: (MORE) group

Group Type EXPERIMENTAL

Mindfulness-Oriented Recovery Enhancement: (MORE) group

Intervention Type BEHAVIORAL

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

Psychoeducation

Group Type PLACEBO_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Psychoeducation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Asimina Lazaridou, PhD

Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brigham and Women's Hospital

Chestnut Hill, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Marie Curiel

Role: primary

617-732-9578

Other Identifiers

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2023P001582

Identifier Type: -

Identifier Source: org_study_id

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