Low Back PainNCT06268522
Adjunctive Mindfulness During Opioid Tapering for patientS With Chronic Pain (The AMOS Study)
A study testing Mindfulness-Oriented Recovery Enhancement: (MORE) group and Psychoeducation in people with Low Back Pain, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Mindfulness-Oriented Recovery Enhancement: (MORE) group and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 28 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
About this study
Official title: 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.
- Conditions
- Low Back Pain
- Being tested
- Mindfulness-Oriented Recovery Enhancement: (MORE) group, Psychoeducation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Oriented Recovery Enhancement: (MORE) groupBehavioural
Mindfulness-Oriented Recovery Enhancement (MORE) is a novel social work intervention and mental training program that unites complementary aspects of mindfulness training.
PsychoeducationBehavioural
Education on the neurobiology of pain, healthy eating, diet, sleep and stress
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Oriented Recovery Enhancement: (MORE) group | Experimental | Not described Receives: Behavioral: Mindfulness-Oriented Recovery Enhancement: (MORE) group |
| Psychoeducation | Placebo comparator | Not described Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Interference
assessed by the Brief pain interventory
Measured: Baseline, 8 weeks, 3 month and 6 month follow up
Opioid Dose
assessed through their medical record
Measured: Baseline, 8 weeks, 3 month and 6 month follow up
Secondary outcomes (4)
Pain Intensity
assessed through the Brief Pain Inventory
Measured: Baseline, 8 weeks, 3 month and 6 month follow up
Opioid Misuse
assessed by the Current Opioid Misuse Measure (COMM)
Measured: Baseline, 8 weeks, 3 month and 6 month follow up
Opioid Withdrawal
assessed by the Opioid Withdrawal Scale (SOWS)
Measured: Baseline, 8 weeks, 3 month and 6 month follow up
Opioid Craving
assessed by the single item Opioid Craving
Measured: Baseline,8 weeks, 3 month and 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Feb 2024
- Primary completion28 Jun 2025
- Study completion28 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Behavioral
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asimina Lazaridou, PhD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268522
- Sponsor's protocol ID
- 2023P001582
- Status last verified
- Jan 2026
- First submitted
- 2 Feb 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet the IPD sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Mindfulness During Opioid Tapering for Patients With Chronic Pain
- ClinicalTrials.gov ID
- NCT06268522
- Acronym / sponsor ID
- 2023P001582
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 28 Jun 2025 (actual)
- Study completion
- 28 Jun 2025 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Behavioral
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Oriented Recovery Enhancement: (MORE) group | Experimental | Behavioral: Mindfulness-Oriented Recovery Enhancement: (MORE) group |
| Psychoeducation | Placebo comparator | Behavioral: Psychoeducation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Oriented Recovery Enhancement: (MORE) groupMindfulness-Oriented Recovery Enhancement (MORE) is a novel social work intervention and mental training program that unites complementary aspects of mindfulness training. | Behavioural | Mindfulness-Oriented Recovery Enhancement: (MORE) group |
| PsychoeducationEducation on the neurobiology of pain, healthy eating, diet, sleep and stress | Behavioural | Psychoeducation |
Primary outcome
Pain Interference
Time frame: Baseline, 8 weeks, 3 month and 6 month follow up
assessed by the Brief pain interventory
Opioid Dose
Time frame: Baseline, 8 weeks, 3 month and 6 month follow up
assessed through their medical record
4 secondary outcomes
Pain Intensity
Time frame: Baseline, 8 weeks, 3 month and 6 month follow up
Opioid Misuse
Time frame: Baseline, 8 weeks, 3 month and 6 month follow up
Opioid Withdrawal
Time frame: Baseline, 8 weeks, 3 month and 6 month follow up
Opioid Craving
Time frame: Baseline,8 weeks, 3 month and 6 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Undecided. Not decided yet the IPD sharing plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Oriented Recovery Enhancement: (MORE) group and Psychoeducation in people with Low Back Pain, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Interference (time frame: Baseline, 8 weeks, 3 month and 6 month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.