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Completed

NCT Number: NCT06268522

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness-Oriented Recovery Enhancement: (MORE) group

Behavioral

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

Psychoeducation

Behavioral

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

Primary outcomes

  1. Pain Interference

    Time frame: Baseline, 8 weeks, 3 month and 6 month follow up

    assessed by the Brief pain interventory

  2. Opioid Dose

    Time frame: Baseline, 8 weeks, 3 month and 6 month follow up

    assessed through their medical record

Secondary outcomes

  1. Pain Intensity

    Time frame: Baseline, 8 weeks, 3 month and 6 month follow up

    assessed through the Brief Pain Inventory

  2. Opioid Misuse

    Time frame: Baseline, 8 weeks, 3 month and 6 month follow up

    assessed by the Current Opioid Misuse Measure (COMM)

  3. Opioid Withdrawal

    Time frame: Baseline, 8 weeks, 3 month and 6 month follow up

    assessed by the Opioid Withdrawal Scale (SOWS)

  4. Opioid Craving

    Time frame: Baseline,8 weeks, 3 month and 6 month follow up

    assessed by the single item Opioid Craving

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Adjunctive Mindfulness During Opioid Tapering for Patients With Chronic Pain

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2024
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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