Chronic PainINSPIRENCT03454555

Integrated Services for Pain: Interventions to Reduce Pain Effectively

A study testing Shared Decision Making and Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain in people with Chronic Pain, run by RTI International at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Chronic Pain
What is being tested?: Shared Decision Making and Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 543 participants
Where: 3 sitesUnited States
Study dates: 26 Jun 2019to 30 Sep 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged 18 to 85 years
History of chronic non-cancer pain (CNCP)
Receiving chronic opioid therapy for CNCP as evidenced by current or most recent prescription of an average daily prescribed dosage of 20 milligrams of morphine equivalents
Receiving care at a participating clinic from a participating provider, as evidenced by at least 1 in-person visit within the past 12 months.

Who cannot join

Not meeting the above inclusion criteria
Opioid use is for pain directly related to an active cancer diagnosis
Opioid use is for maintenance treatment of an opioid use disorder
Suicide attempt within the past 3 years
Active suicidal ideation
Currently receiving Cognitive-Behavioral Therapy (CBT)
Non-English speaking
Other reason at the discretion of the investigator

Trial locations and contacts

3 sites in 1 country.

United States3 sites

University of North Carolina Health Care System
Chapel Hill, North Carolina, 27599
Duke University Health System
Durham, North Carolina, 27701
Vanderbilt University Medical Center
Nashville, Tennessee, 27232

Other trials in United States

About this study

Official title: Integrated Health Services to Reduce Opioid Use While Managing Chronic Pain

Long-term pain -or pain that lasts for months or years-is one of the most common health problems in the United States. Clinicians often prescribe opioids which can help ease pain in the short term, but evidence does not support their effectiveness over the long term. For some people, long-term opioid use can lead to addiction and overdose. People need effective options and support to help maintain or improve their function and quality of life.

This study compared two programs for helping people living with long-term pain who have been prescribed opioids for 3 or more months. This study was done at primary care and pain care clinics at 3 health systems in the Southeastern United States.

The study team assigned people by chance to one of two study programs: (1) individual motivational interviewing plus group-based cognitive behavioral therapy (MI+CBT) or (2) patient-clinician shared decision making. In the MI+CBT program, the patient learned strategies to better cope with chronic pain. In the SDM program, the patient and clinician worked together through enhanced communication to make decisions that aligned with values and preferences of the patient.

The study team compared the two programs by looking at changes in opioid dosage, physical functioning, and pain interference over time. They collected information about prescribed opioid dosage from electronic health records and patients completed surveys at the start of the study and 6 and 12 months later.

The study team worked with an advisory group that included patients, advocates, clinicians, and pain experts. The advisory group met with the study team two to three times per year to provide input on the study.

Read the detailed description

Objective:

To compare the effectiveness of individual motivational interviewing plus group-based cognitive behavioral therapy (MI+CBT) versus patient-clinician shared decision making (SDM) on change in daily dosage of prescribed opioids, physical functioning, and pain interference for individuals with chronic non-cancer pain (CNCP).

Rationale:

About 24% of Americans suffer from CNCP and clinicians often prescribe opioids to treat it. Once on chronic opioid therapy (COT), individuals often continue with this class of medication for years. Evidence for the effectiveness of COT to treat CNCP is limited, exposing individuals to known risks. Modified or novel pharmacological and nonpharmacological strategies are needed to improve pain management and promote informed decision making regarding possible opioid dose reduction.

Study Design and Approach:

This was a large-scale, pragmatic randomized controlled trial implementing pharmacotherapy guidelines and behavioral interventions in real-world settings. A key eligibility criterion was individuals who were prescribed ≥ 20 milligrams of morphine equivalents for more than three months.

Interventions:

Researchers examined the comparative effectiveness of MI+CBT versus SDM for who are on COT. Neither approach is directive, and both support patient choice. Although MI+CBT and SDM are both behavioral intervention strategies, they differ in content covered and training of those delivering the intervention (behavioral vs. medical). Participants in both study arms received guideline-concordant pharmacotherapy treatment, based on clinical guidelines for opioid therapy for CNCP.

Outcomes:

Primary: The change from baseline in average daily prescribed opioid dosage, measured in milligrams of morphine equivalents, at 12 months, with secondary time points at 6 months and 18 months
Secondary: The change from baseline to 6 and 12 months (primary timepoint) in the PROMIS Short Form v1.0 Pain Interference and PROMIS Short Form v1.0 Physical Function scales.

Timeline:

The project commenced in February 2018. Participant recruitment occurred from June 2019 to March 2022. Delivery of the intervention occurred on a rolling basis through March 2023.

Recruitment, Screening, Enrollment, and Randomization:

The study randomized 525 participants from primary care and pain clinics at three medical centers in North Carolina and Tennessee. The researchers identified individuals who were potentially eligible through electronic health records and invited them to participate. A Research Coordinator contacted individuals to complete screening, enrollment, and randomization.

Data Collection:

The researchers collected validated patient-reported outcomes through Web-based and phone-based surveys and leveraged existing harmonized electronic health record (EHR) data for clinical outcomes.

Data Analysis:

Outcomes were analyzed for all randomized participants in an intent-to-treat fashion, irrespective of the amount of intervention received. Because some individuals did not attend an intervention session, sensitivity analyses were based on a modified intent-to-treat population limited to participants receiving at least 1 intervention session and a per-protocol population limited to participants receiving at least four CBT or SDM sessions.

Changes from baseline were analyzed with a repeated measures linear model accounting for correlation of measurements over time, with effects for intervention arm, time interval as a categorical predictor, intervention-by-time interaction, and adjustment for baseline value and study site. Differential treatment effects for two preplanned subgroups based on sex and prior mental health diagnosis, as defined by IDC-10 codes recorded in the EHR, were assessed at 12 months via a subgroup-by-intervention interaction within the repeated measures model.

Qualitative research methods were used to obtain participant input on their experiences.

Conditions: Chronic Pain
Being tested: Shared Decision Making, Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain
Keywords: Pragmatic Clinical Trial, Comparative Effectiveness Research, Analgesics, Opioid, Decision Making, Shared, Motivational Interviewing, Cognitive Therapy, Patient Reported Outcome Measures, Chronic Pain, Pain, Neurologic Manifestations
Medical subject headings: Chronic Pain, Pain, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Shared Decision MakingBehavioural
The Shared Decision Making (SDM) intervention is a patient-provider communication intervention to explore and compare treatment options, assess a patient's values and preferences, and reach a shared decision about chronic pain treatment. Participants in the SDM arm received their regular pain care visits with a designated SDM-trained clinician over a 12-month period. SDM intervention participants scheduled pain visits as often as needed for pain management (typically quarterly). SDM participants also received an electronic and physical packet of educational materials after randomization.
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic PainBehavioural
The Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) intervention is an empirically based behavioral pain management behavioral therapy intervention, including MI to enhance motivation for active participation in the CBT-CP, and the use of CBT-CP to enhance pain coping skills. MI + CBT-CP participants received one MI session plus up to eight weekly CBT-CP group sessions.

Study groups in NCT03454555
Study group	Role	What they receive
Shared Decision Making (SDM)	Active comparator	Shared Decision Making (SDM) participants received guideline-concordant pharmacotherapy based on clinical guidelines for opioid therapy for chronic noncancer pain plus the SDM intervention during their opioid management visits. Receives: Behavioral: Shared Decision Making
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)	Active comparator	Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) participants received the guideline-concordant pharmacotherapy based on clinical guidelines for opioid therapy for chronic noncancer pain plus the MI+CBT-CP intervention. Receives: Behavioral: Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 12
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 12 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Measured: Month 12 (PRIMARY TIMEPOINT)
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 3
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 3 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Measured: Month 3
Change From Baseline in Average Daily Opioid Dose in in Morphine Milligram Equivalents (MME) at Month 6
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 6 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Measured: Month 6
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 9
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 9 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Measured: Month 9
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 15
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 15 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Measured: Month 15
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 18
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 18 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Measured: Month 18
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 12
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Measured: Month 12
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 3
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Measured: Month 3
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 6
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Measured: Month 6
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 9
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Measured: Month 9
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 15
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Measured: Month 15
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 18
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Measured: Month 18

Secondary outcomes (4)

Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 6
The Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) is a validated, self-reported instrument assessing pain interference over the past 7 days. Pain interference is a measure of the extent to which pain interferes with patient physical, mental, and social activities. Possible scores on each item range in value from 1 (not at all) to 5 (very much). Higher T-scores indicate higher pain interference and worse health. Change = Month 6 Score - Baseline Score.
Measured: Month 6
Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 12
The Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) is a validated, self-reported instrument assessing pain interference over the past 7 days. Pain interference is a measure of the extent to which pain interferes with patient physical, mental, and social activities. Possible scores on each item range in value from 1 (not at all) to 5 (very much). Higher T-scores indicate higher pain interference and worse health. Change = Month 12 Score - Baseline Score.
Measured: Month 12
Change From Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 6
The Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) is a validated, self-reported instrument assessing physical functioning over the past 7 days. Physical functioning measures one's upper extremities (dexterity), lower extremities (walking and mobility), central regions (back and neck), and instrumental activities of daily living.
Possible scores on each item range in value from 1 (without any difficulty) to 5 (unable to do). Higher T-scores indicate higher physical functioning and better health. Change = Month 6 Score - Baseline Score.
Measured: Month 6
Change From Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 12
The Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) is a validated, self-reported instrument assessing physical functioning over the past 7 days. Physical functioning measures one's upper extremities (dexterity), lower extremities (walking and mobility), central regions (back and neck), and instrumental activities of daily living.
Possible scores on each item range in value from 1 (without any difficulty) to 5 (unable to do). Higher T-scores indicate higher physical functioning and better health. Change = Month 12 Score - Baseline Score.
Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 201930 Sep 2023

First posted6 Mar 2018
Study start26 Jun 2019
Primary completion30 Sep 2023
Study completion30 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies of the same condition, open and under way.
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: Participants were randomly assigned to one of two intervention arms for the duration of the study. The study used real-time 1:1 ratio randomization to limit participant loss prior to treatment. Eligible patients were randomized using a stratified, permuted-block design, as this constrained randomization approach ensured balance between treatment groups within each of the 3 clinical institutions (the only stratification factor) at the completion of each block. Consequently, throughout the trial, the intervention arms were expected to have approximately equal sample sizes both within an institution and across the study.
Masking: None (open label)
Enrolment: 543 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03454555
Sponsor's protocol ID: PCORI-OPD-1610-37006
Acronym: INSPIRE
Status last verified: Jul 2025
First submitted: 27 Feb 2018
Last updated: 12 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: RTI International plans to make available data from this study through the Patient-Centered Outcomes Data Repository (PCODR). The data package will include a de-identified copy of datasets containing all derived data used for all analysis and reporting.

Publications

Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
PubMed 3558716
Chou R, Deyo R, Devine B, Hansen R, Sullivan S, Jarvik JG, Blazina I, Dana T, Bougatsos C, Turner J. The Effectiveness and Risks of Long-Term Opioid Treatment of Chronic Pain. Evid Rep Technol Assess (Full Rep). 2014 Sep;(218):1-219. doi: 10.23970/AHRQEPCERTA218.
PubMed 30313000
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
PubMed 8080219
Rose M, Bjorner JB, Gandek B, Bruce B, Fries JF, Ware JE Jr. The PROMIS Physical Function item bank was calibrated to a standardized metric and shown to improve measurement efficiency. J Clin Epidemiol. 2014 May;67(5):516-26. doi: 10.1016/j.jclinepi.2013.10.024.
PubMed 24698295
Tan G, Jensen MP, Thornby JI, Shanti BF. Validation of the Brief Pain Inventory for chronic nonmalignant pain. J Pain. 2004 Mar;5(2):133-7. doi: 10.1016/j.jpain.2003.12.005.
PubMed 15042521
Amtmann D, Cook KF, Jensen MP, Chen WH, Choi S, Revicki D, Cella D, Rothrock N, Keefe F, Callahan L, Lai JS. Development of a PROMIS item bank to measure pain interference. Pain. 2010 Jul;150(1):173-182. doi: 10.1016/j.pain.2010.04.025.
PubMed 20554116
Bann CM, McCormack LA, Berkman ND, Squiers LB. The Health Literacy Skills Instrument: a 10-item short form. J Health Commun. 2012;17 Suppl 3(Suppl 3):191-202. doi: 10.1080/10810730.2012.718042.
PubMed 23030570
Boonstra AM, Schiphorst Preuper HR, Balk GA, Stewart RE. Cut-off points for mild, moderate, and severe pain on the visual analogue scale for pain in patients with chronic musculoskeletal pain. Pain. 2014 Dec;155(12):2545-2550. doi: 10.1016/j.pain.2014.09.014. Epub 2014 Sep 17.
PubMed 25239073
Edlund MJ, Thomas SM, Wagner LK, Thompson JE, Wu LT, Dolor RJ, Chelminski PR, Ives TJ, Archer KR, Dewey CM, Sullivan MD, McCormack LA; INSPIRE Study Team. Design of a Multicenter Randomized Controlled Trial comparing the effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for voluntary opioid tapering: The INSPIRE study protocol. Contemp Clin Trials. 2024 Feb;137:107410. doi: 10.1016/j.cct.2023.107410. Epub 2023 Dec 12.
PubMed 38092285
Martin BC, Fan MY, Edlund MJ, Devries A, Braden JB, Sullivan MD. Long-term chronic opioid therapy discontinuation rates from the TROUP study. J Gen Intern Med. 2011 Dec;26(12):1450-7. doi: 10.1007/s11606-011-1771-0. Epub 2011 Jul 13.
PubMed 21751058
Monticone M, Ambrosini E, Cedraschi C, Rocca B, Fiorentini R, Restelli M, Gianola S, Ferrante S, Zanoli G, Moja L. Cognitive-behavioral Treatment for Subacute and Chronic Neck Pain: A Cochrane Review. Spine (Phila Pa 1976). 2015 Oct 1;40(19):1495-504. doi: 10.1097/BRS.0000000000001052.
PubMed 26192729
Rose M, Bjorner JB, Becker J, Fries JF, Ware JE. Evaluation of a preliminary physical function item bank supported the expected advantages of the Patient-Reported Outcomes Measurement Information System (PROMIS). J Clin Epidemiol. 2008 Jan;61(1):17-33. doi: 10.1016/j.jclinepi.2006.06.025.
PubMed 18083459
Vanderlip ER, Sullivan MD, Edlund MJ, Martin BC, Fortney J, Austen M, Williams JS, Hudson T. National study of discontinuation of long-term opioid therapy among veterans. Pain. 2014 Dec;155(12):2673-2679. doi: 10.1016/j.pain.2014.09.034. Epub 2014 Sep 30.
PubMed 25277462
McCormack LA, Edlund MJ, Thomas SM, Wu LT, Chelminski PR, Archer KR, Wagner LK, Hirsch S, Thompson JE, Dolor RJ, Ives TJ, Dewey CM, Chang S; INSPIRE Study Team. Effectiveness of motivational interviewing plus cognitive behavioral therapy vs shared decision making for voluntary opioid tapering in patients with chronic pain: the INSPIRE randomized pragmatic trial. Pain Med. 2025 Aug 1;26(8):477-489. doi: 10.1093/pm/pnaf049.
PubMed 40338272
Chang SH, Hirsch SC, Thomas SM, Edlund MJ, Dolor RJ, Ives TJ, Dewey CM, Gulur P, Chelminski PR, Archer KR, Wu LT, Curtis J, Goldstein AO, McCormack LA; INSPIRE Study Team. Complexities and approaches for deriving longitudinal daily morphine milligram equivalents using electronic health record prescription data. JAMIA Open. 2025 Jun 16;8(3):ooaf053. doi: 10.1093/jamiaopen/ooaf053. eCollection 2025 Jun.
PubMed 40524838

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Integrated Health Services to Reduce Opioid Use While Managing Chronic Pain
ClinicalTrials.gov ID: NCT03454555
Acronym / sponsor ID: INSPIRE / PCORI-OPD-1610-37006
Conditions: Chronic Pain
Keywords: Pragmatic Clinical Trial, Comparative Effectiveness Research, Analgesics, Opioid, Decision Making, Shared, Motivational Interviewing, Cognitive Therapy, Patient Reported Outcome Measures, Chronic Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 543 participants (actual)
Lead sponsor: RTI InternationalUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute, University of North Carolina Health Care System, Duke Health, Vanderbilt University Medical Center
Study start: 26 Jun 2019 (actual)
Primary completion: 30 Sep 2023 (actual)
Study completion: 30 Sep 2023 (actual)
First posted: 6 Mar 2018 (actual)
Results: Posted 12 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objective:

Rationale:

Study Design and Approach:

Interventions:

Outcomes:

Primary: The change from baseline in average daily prescribed opioid dosage, measured in milligrams of morphine equivalents, at 12 months, with secondary time points at 6 months and 18 months
Secondary: The change from baseline to 6 and 12 months (primary timepoint) in the PROMIS Short Form v1.0 Pain Interference and PROMIS Short Form v1.0 Physical Function scales.

Timeline:

The project commenced in February 2018. Participant recruitment occurred from June 2019 to March 2022. Delivery of the intervention occurred on a rolling basis through March 2023.

Recruitment, Screening, Enrollment, and Randomization:

Data Collection:

The researchers collected validated patient-reported outcomes through Web-based and phone-based surveys and leveraged existing harmonized electronic health record (EHR) data for clinical outcomes.

Data Analysis:

Qualitative research methods were used to obtain participant input on their experiences.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants were randomly assigned to one of two intervention arms for the duration of the study. The study used real-time 1:1 ratio randomization to limit participant loss prior to treatment. Eligible patients were randomized using a stratified, permuted-block design, as this constrained randomization approach ensured balance between treatment groups within each of the 3 clinical institutions (the only stratification factor) at the completion of each block. Consequently, throughout the trial, the intervention arms were expected to have approximately equal sample sizes both within an institution and across the study.

Arm	Type	Receives
Shared Decision Making (SDM)	Active comparator	Behavioral: Shared Decision MakingShared Decision Making (SDM) participants received guideline-concordant pharmacotherapy based on clinical guidelines for opioid therapy for chronic noncancer pain plus the SDM intervention during their opioid management visits.
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)	Active comparator	Behavioral: Motivational Interviewing and Cognitive Behavioral Therapy for Chronic PainMotivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) participants received the guideline-concordant pharmacotherapy based on clinical guidelines for opioid therapy for chronic noncancer pain plus the MI+CBT-CP intervention.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Aged 18 to 85 years
History of chronic non-cancer pain (CNCP)
Receiving chronic opioid therapy for CNCP as evidenced by current or most recent prescription of an average daily prescribed dosage of 20 milligrams of morphine equivalents
Receiving care at a participating clinic from a participating provider, as evidenced by at least 1 in-person visit within the past 12 months.

Key exclusion criteria (8 listed)

Not meeting the above inclusion criteria
Opioid use is for pain directly related to an active cancer diagnosis
Opioid use is for maintenance treatment of an opioid use disorder
Suicide attempt within the past 3 years
Active suicidal ideation

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
Shared Decision MakingThe Shared Decision Making (SDM) intervention is a patient-provider communication intervention to explore and compare treatment options, assess a patient's values and preferences, and reach a shared decision about chronic pain treatment. Participants in the SDM arm received their regular pain care visits with a designated SDM-trained clinician over a 12-month period. SDM intervention participants scheduled pain visits as often as needed for pain management (typically quarterly). SDM participants also received an electronic and physical packet of educational materials after randomization.	Behavioural	Shared Decision Making (SDM)
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic PainThe Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) intervention is an empirically based behavioral pain management behavioral therapy intervention, including MI to enhance motivation for active participation in the CBT-CP, and the use of CBT-CP to enhance pain coping skills. MI + CBT-CP participants received one MI session plus up to eight weekly CBT-CP group sessions.	Behavioural	Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)

Primary outcome

Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 12
Time frame: Month 12 (PRIMARY TIMEPOINT)
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 12 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 3
Time frame: Month 3
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 3 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Change From Baseline in Average Daily Opioid Dose in in Morphine Milligram Equivalents (MME) at Month 6
Time frame: Month 6
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 6 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 9
Time frame: Month 9
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 9 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 15
Time frame: Month 15
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 15 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 18
Time frame: Month 18
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 18 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 12
Time frame: Month 12
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 3
Time frame: Month 3
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 6
Time frame: Month 6
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 9
Time frame: Month 9
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 15
Time frame: Month 15
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 18
Time frame: Month 18
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.

4 secondary outcomes

Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 6
Time frame: Month 6
Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 12
Time frame: Month 12
Change From Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 6
Time frame: Month 6
Change From Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 12
Time frame: Month 12

Results and safety

Results posted to the registry on 12 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)	263	189
Shared Decision Making (SDM)	262	228

Primary outcome: Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 12

Time frame: Month 12 (PRIMARY TIMEPOINT). Least squares mean (95% Confidence Interval). Unit: Morphine Milligram Equivalents (MME)

Measure	Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) n = 220	Shared Decision Making (SDM) n = 223
Value	-11.6 (-19.1 to -4.1)	-6.0 (-14.0 to 2.0)

Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) vs Shared Decision Making (SDM): Mean Difference (Final Values): -5.6 (95% CI -16.6 to 5.3), p = 0.31, Mixed Models Analysis

Population analysed: Intent-to-treat population; those missing EHR prescription data at a certain timepoint did not contribute data for that timepoint in the mixed repeated measures model.

Primary outcome: Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 3

Time frame: Month 3. Least squares mean (95% Confidence Interval). Unit: Morphine Milligram Equivalents (MME)

Measure	Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) n = 254	Shared Decision Making (SDM) n = 253
Value	0.0 (-7.2 to 7.1)	-0.3 (-8.0 to 7.4)

Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) vs Shared Decision Making (SDM): Mean Difference (Final Values): 0.3 (95% CI -10.3 to 10.7), p = 0.963, Mixed Models Analysis

Population analysed: Intent-to-treat population; those missing EHR prescription data at a certain timepoint did not contribute data for that timepoint in the mixed repeated measures model.

Primary outcome: Change From Baseline in Average Daily Opioid Dose in in Morphine Milligram Equivalents (MME) at Month 6

Time frame: Month 6. Least squares mean (95% Confidence Interval). Unit: Morphine Milligram Equivalents (MME)

Measure	Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) n = 238	Shared Decision Making (SDM) n = 247
Value	-5.9 (-13.2 to 1.4)	0.3 (-7.4 to 8.1)

Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) vs Shared Decision Making (SDM): Mean Difference (Final Values): -6.2 (95% CI -16.8 to 4.4), p = 0.253, Mixed Models Analysis

Population analysed: Intent-to-treat population; those missing EHR prescription data at a certain timepoint did not contribute data for that timepoint in the mixed repeated measures model.

Primary outcome: Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 9

Time frame: Month 9. Least squares mean (95% Confidence Interval). Unit: Morphine Milligram Equivalents (MME)

Measure	Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) n = 228	Shared Decision Making (SDM) n = 236
Value	-6.6 (-14.0 to 0.8)	-7.3 (-15.1 to 0.6)

Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) vs Shared Decision Making (SDM): Mean Difference (Final Values): 0.7 (95% CI -10.1 to 11.5), p = 0.90, Mixed Models Analysis

Population analysed: Intent-to-treat population; those missing EHR prescription data at a certain timepoint did not contribute data for that timepoint in the mixed repeated measures model.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were reported from baseline through the 12-month intervention phase of the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Shared Decision Making (SDM)	21 of 262 (8%)	0 of 0	6 of 262
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)	17 of 263 (6.5%)	0 of 0	6 of 263

Limitations and caveats (from the sponsor): Academic medical centers as study sites may limit applicability to other settings. Patients mostly on low or medium opioid doses. INSPIRE was conducted during the peak of coronavirus disease 2019 (COVID-19). Technological barriers could have hindered participation. Clinicians and patients may have been reluctant to taper opioids during telehealth visits. Pandemic-related hardships may have affected self-reported quality of life measures.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 3558716Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
Background: PubMed 30313000Chou R, Deyo R, Devine B, Hansen R, Sullivan S, Jarvik JG, Blazina I, Dana T, Bougatsos C, Turner J. The Effectiveness and Risks of Long-Term Opioid Treatment of Chronic Pain. Evid Rep Technol Assess (Full Rep). 2014 Sep;(218):1-219. doi: 10.23970/AHRQEPCERTA218.
Background: PubMed 8080219Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
Background: PubMed 24698295Rose M, Bjorner JB, Gandek B, Bruce B, Fries JF, Ware JE Jr. The PROMIS Physical Function item bank was calibrated to a standardized metric and shown to improve measurement efficiency. J Clin Epidemiol. 2014 May;67(5):516-26. doi: 10.1016/j.jclinepi.2013.10.024.
Background: PubMed 15042521Tan G, Jensen MP, Thornby JI, Shanti BF. Validation of the Brief Pain Inventory for chronic nonmalignant pain. J Pain. 2004 Mar;5(2):133-7. doi: 10.1016/j.jpain.2003.12.005.
Background: PubMed 20554116Amtmann D, Cook KF, Jensen MP, Chen WH, Choi S, Revicki D, Cella D, Rothrock N, Keefe F, Callahan L, Lai JS. Development of a PROMIS item bank to measure pain interference. Pain. 2010 Jul;150(1):173-182. doi: 10.1016/j.pain.2010.04.025.
Background: PubMed 23030570Bann CM, McCormack LA, Berkman ND, Squiers LB. The Health Literacy Skills Instrument: a 10-item short form. J Health Commun. 2012;17 Suppl 3(Suppl 3):191-202. doi: 10.1080/10810730.2012.718042.
Background: PubMed 25239073Boonstra AM, Schiphorst Preuper HR, Balk GA, Stewart RE. Cut-off points for mild, moderate, and severe pain on the visual analogue scale for pain in patients with chronic musculoskeletal pain. Pain. 2014 Dec;155(12):2545-2550. doi: 10.1016/j.pain.2014.09.014. Epub 2014 Sep 17.
Background: PubMed 38092285Edlund MJ, Thomas SM, Wagner LK, Thompson JE, Wu LT, Dolor RJ, Chelminski PR, Ives TJ, Archer KR, Dewey CM, Sullivan MD, McCormack LA; INSPIRE Study Team. Design of a Multicenter Randomized Controlled Trial comparing the effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for voluntary opioid tapering: The INSPIRE study protocol. Contemp Clin Trials. 2024 Feb;137:107410. doi: 10.1016/j.cct.2023.107410. Epub 2023 Dec 12.
Background: PubMed 21751058Martin BC, Fan MY, Edlund MJ, Devries A, Braden JB, Sullivan MD. Long-term chronic opioid therapy discontinuation rates from the TROUP study. J Gen Intern Med. 2011 Dec;26(12):1450-7. doi: 10.1007/s11606-011-1771-0. Epub 2011 Jul 13.
Background: PubMed 26192729Monticone M, Ambrosini E, Cedraschi C, Rocca B, Fiorentini R, Restelli M, Gianola S, Ferrante S, Zanoli G, Moja L. Cognitive-behavioral Treatment for Subacute and Chronic Neck Pain: A Cochrane Review. Spine (Phila Pa 1976). 2015 Oct 1;40(19):1495-504. doi: 10.1097/BRS.0000000000001052.
Background: PubMed 18083459Rose M, Bjorner JB, Becker J, Fries JF, Ware JE. Evaluation of a preliminary physical function item bank supported the expected advantages of the Patient-Reported Outcomes Measurement Information System (PROMIS). J Clin Epidemiol. 2008 Jan;61(1):17-33. doi: 10.1016/j.jclinepi.2006.06.025.
Study description on research team's organizational websiteLink provided by the sponsor.
Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (US); 2011.Link provided by the sponsor.
Study description on funder's websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. RTI International plans to make available data from this study through the Patient-Centered Outcomes Data Repository (PCODR). The data package will include a de-identified copy of datasets containing all derived data used for all analysis and reporting.

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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.

Lauren McCormack, PhD, MSPH principal investigator

RTI International

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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. 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?

Yes. Results are posted in the registry (first posted 12 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 12 (time frame: Month 12 (PRIMARY TIMEPOINT)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03454555, which also lists 16 linked publications.

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 12 Aug 2025.