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

January 28, 2026 updated by: Asimina Lazaridou, PhD, Brigham and Women's Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Interference
Time Frame: Baseline, 8 weeks, 3 month and 6 month follow up
assessed by the Brief pain interventory
Baseline, 8 weeks, 3 month and 6 month follow up
Opioid Dose
Time Frame: Baseline, 8 weeks, 3 month and 6 month follow up
assessed through their medical record
Baseline, 8 weeks, 3 month and 6 month follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: Baseline, 8 weeks, 3 month and 6 month follow up
assessed through the Brief Pain Inventory
Baseline, 8 weeks, 3 month and 6 month follow up
Opioid Misuse
Time Frame: Baseline, 8 weeks, 3 month and 6 month follow up
assessed by the Current Opioid Misuse Measure (COMM)
Baseline, 8 weeks, 3 month and 6 month follow up
Opioid Withdrawal
Time Frame: Baseline, 8 weeks, 3 month and 6 month follow up
assessed by the Opioid Withdrawal Scale (SOWS)
Baseline, 8 weeks, 3 month and 6 month follow up
Opioid Craving
Time Frame: Baseline,8 weeks, 3 month and 6 month follow up
assessed by the single item Opioid Craving
Baseline,8 weeks, 3 month and 6 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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