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

Low Back Pain Clinical Trial

Official title:

Adjunctive Mindfulness During Opioid Tapering for Patients With Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06268522
• Other study ID #: 2023P001582
• Status: Recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Chestnut Hill	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Interference	assessed by the Brief pain interventory	Baseline, 8 weeks, 3 month and 6 month follow up
Primary	Opioid Dose	assessed through their medical record	Baseline, 8 weeks, 3 month and 6 month follow up
Secondary	Pain Intensity	assessed through the Brief Pain Inventory	Baseline, 8 weeks, 3 month and 6 month follow up
Secondary	Opioid Misuse	assessed by the Current Opioid Misuse Measure (COMM)	Baseline, 8 weeks, 3 month and 6 month follow up
Secondary	Opioid Withdrawal	assessed by the Opioid Withdrawal Scale (SOWS)	Baseline, 8 weeks, 3 month and 6 month follow up
Secondary	Opioid Craving	assessed by the single item Opioid Craving	Baseline,8 weeks, 3 month and 6 month follow up