Chronic PainPhase 4NCT06574009
Better Options for Chronic Cancer Pain
A Phase 4 study testing Multimodal pain care, Medication optimization and Buprenorphine rotation in people with Chronic Pain and Cancer Survivor, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
This proposal is relevant to the 240,000 cancer survivors who continue to use opioids long after they have successfully completed treatment for cancer at the VHA, placing them at risk of opioid addiction and overdose, and other opioid-related problems. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Cancer Survivor, Opioid Dependence
- What is being tested?
- Multimodal pain care, Medication optimization and Buprenorphine rotation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Oct 2025to 31 Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veterans must have had a qualifying solid tumor (bladder, breast, colorectal, head and neck, liver, lung, pancreas, prostate, or urinary tract) without evidence of active disease for at least 6 months
- Participants must be 6 months away from their last receipt of cytotoxic, radiation, or surgical cancer treatments but can be on hormonal or biologic therapies needed to sustain remission or cancer control.
- Participants must report pain >=4 (on 0-10 NRS) on their last 3 recordings in the electronic medical record. Veterans should be on Long Term Opioid Therapy (LTOT) defined as:
- a qualifying opioid analgesic dispensed within the prior 30 days
- plus 150 days' supply of a qualifying opioid (fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone) in the 180 days before the most recent dispensing date with no between-fill gaps >40 days
- There must be advance agreement from their existing opioid prescriber to resume opioid prescribing after study
Who cannot join
- Veterans with total daily opioid doses >= 300 Morphine Milligram Equivalents (MME) will be excluded (higher doses require tapering prior to rotation to buprenorphine, which is something the investigators do not want to examine in this study)
- Veterans with referrals or visits to a substance abuse clinic within the prior 2 years will be excluded to avoid including individuals requiring addiction expertise that is not available one the multidisciplinary pain teams
- The investigators will also exclude Veterans with:
- current or past use of buprenorphine
- active alcohol use disorder or substance use
- risk factors for opioid overdose (e.g. active suicidality or history of self-directed violence)
Show all 10Show fewer
- daily use of benzodiazepines
- receipt of opioids from non-VA providers in the prior 3 months
- or aberrant urine drug screen at baseline (cannabis is not exclusionary)
- To ensure the relevance of our work to as many Veteran cancer survivors as possible, the investigators will not exclude subjects meeting DSM criteria for opioid use disorder if their only source of opioids is the VA
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
Maria J Silveira, MD MA MPH, 734-845-3502, Maria.Silveira2@va.gov
- Not yet recruiting
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
David Haggstrom, MD, dahaggst@iu.edu
Jasma Adams, BA, jasma.adams2@va.gov
About this study
Official title: Better Options for Chronic Cancer Pain: a SMART Study
This proposal is relevant to the 240,000 cancer survivors who continue to use opioids long after they have successfully completed treatment for cancer at the VHA, placing them at risk of opioid addiction and overdose, and other opioid-related problems. Yet, there are no programs at the VHA to help them find alternatives to opioids, nor evidence to inform the choice of interventions. This study will meet these needs by examining four interventions that are effective at reducing opioid use in patients with chronic musculoskeletal pain but have yet to be tested in cancer survivors on long term opioid therapy. The proposed work is relevant to the VHA Pain Office's mission to provide Veterans better pain management while limiting the risks of long-term opioid therapy and it aligns with VHA Research and Development's priority to examine clinical interventions for tapering opioids. Successful completion this project will keep VHA at the forefront of the battle against the opioid epidemic with a strategy that may be adapted to address the same needs in non-Veterans.
Read the detailed description
Background: Twenty-four percent of Veterans who survive cancer remain on long term opioid therapy (LTOT) after completing cancer treatment, placing them at significant risk of opioid addiction, overdose, and other opioid-related health conditions. To reduce opioid use in this population, the investigators will examine the impacts of multimodal pain care and buprenorphine rotation - two strategies that have demonstrated efficacy in Veterans with musculoskeletal pain on LTOT but have not been tested in cancer survivors on LTOT, revealing a critical knowledge gap. The overall scientific premise of this project is that these two approaches can effectively reduce LTOT in cancer survivors without worsening chronic pain, and that they are better than pain medication optimization and opioid tapering. The primary objective is to examine which treatment strategy or combination of strategies is most successful at achieving a reduction in LTOT without worsening chronic pain over 6 and 9 months. The investigators will also identify the key challenges and strategies in the implementation of each treatment strategy to facilitate future translation of study findings into VA practice.
Significance: There are currently no care pathways at the VHA to help cancer survivors on LTOT find alternatives to opioids for managing chronic pain, nor evidence to guide which interventions to include. By addressing these unmet needs, this work aligns with POU-AMP's priority to examine clinical interventions for tapering opioid medications.
Innovation: The investigators are among the first to examine multimodal care and buprenorphine rotation to reduce LTOT in cancer survivors. Also, the investigators are among the first to apply VHA's evidence-based, stepped care model of multidisciplinary pain care to cancer survivors on LTOT.
Aim 1: To test if Veterans who receive multimodal pain care will be more likely to decrease total daily opioid use by at least 20% at 6 and 9 months without experiencing worsened pain interference compared to those who receive optimization of non-opioid pain medications.
Aim 2: To test if Veterans who do not respond to 6 months of multimodal care or medication optimization are more likely to achieve the desired outcome at 9 months when they are offered buprenorphine rotation as opposed to opioid tapering.
Exploratory Aim 3: To examine which combination of interventions is most likely to achieve the desired outcome at 9 months.
Aim 4: To understand the key challenges and strategies in the implementation of each intervention to facilitate future translation of study findings into practice.
Methodology: The investigators plan a two-site, two-stage, response-adaptive, comparative effectiveness trial following SMART (Sequential, Multiple-Assignment Randomized Trial) principles. The investigators will enroll 294 Veteran cancer survivors on LTOT who receive their care at the Indianapolis or Ann Arbor VAMC. Subjects will be randomized to either multimodal pain care or pain medication optimization at Stage 1. After 6 months, non-respondents will be randomized to buprenorphine rotation or opioid tapering in Stage 2. The primary outcome is a composite variable combining one objective outcome (opioid dose reduction) and one subjective outcome (pain interference), assessed at 6 and 9 months. The secondary outcomes are opioid dose reduction and pain interference individually.
Next Steps/Implementation: Successful execution of this project will provide actionable information, including an implementation strategy, that VHA's Offices of Pain Management and Oncology can put in place to support over 240,000 cancer survivors on LTOT for chronic pain.
- Conditions
- Chronic Pain, Cancer Survivor, Opioid Dependence
- Being tested
- Multimodal pain care, Medication optimization, Buprenorphine rotation, Opioid tapering
- Keywords
- survivorship, chronic pain, analgesics
- Medical subject headings
- Chronic Pain, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal pain careBehavioural
Behavioral therapy (as below), physical therapy, assistive devices (e.g. TENS, bracing), referrals to VA specialists (e.g. interventional pain), and complementary and integrative therapies (e.g. acupuncture or massage
Medication optimizationDrug
Medications will be optimized following an algorithm the investigators created based upon NCCN's Survivorship Guidelines and AHRQ's comprehensive review of non-opioid treatments for chronic pain.
Buprenorphine rotationDevice
Subjects randomized to this arm at 6 months will be offered the chance to rotate from their full mu agonist opioid to buprenorphine using a standardized protocol
Opioid taperingOther
Subjects randomized to tapering will receive recommendations based upon the VA PBM's opioid tapering reference guide
| Study group | Role | What they receive |
|---|---|---|
| Multimodal pain care 9 months | Experimental | Findings from the comprehensive pain assessment will be used to inform an individualized, multimodal plan crafted by the team physician with the subject's collaboration Receives: Behavioral: Multimodal pain care |
| Medication optimization | Experimental | Findings from the comprehensive pain assessment will be used to inform a medication-focused pain plan. Receives: Behavioral: Multimodal pain care; Device: Buprenorphine rotation |
| Multimodal pain care 6 months / Opioid tapering 3 months | Experimental | Findings from the comprehensive pain assessment will be used to inform an individualized, multimodal plan crafted by the team physician with the subject's collaboration. After 6 mo, subjects will attempt to taper opioids Receives: Behavioral: Multimodal pain care; Other: Opioid tapering |
| Medication optimization 9 months | Experimental | Findings from the comprehensive pain assessment will be used to inform a medication-focused pain plan. Medications will be optimized following an algorithm the investigators created based upon NCCN's Survivorship Guidelines and AHRQ's comprehensive review of non-opioid treatments for chronic pain. Receives: Drug: Medication optimization |
| Medication optimization 6 months/ Buprenorphine rotation 3 months | Experimental | Findings from the comprehensive pain assessment will be used to inform a medication-focused pain plan. Medications will be optimized following an algorithm the investigators created based upon NCCN's Survivorship Guidelines and AHRQ's comprehensive review of non-opioid treatments for chronic pain. After 6mo, subjects will receive buprenorphine and attempt to taper opioids for following 3 mo. Receives: Drug: Medication optimization; Device: Buprenorphine rotation |
| Medication optimization 6 months/ Opioid tapering 3 months | Experimental | Findings from the comprehensive pain assessment will be used to inform a medication-focused pain plan. Medications will be optimized following an algorithm the investigators created based upon NCCN's Survivorship Guidelines and AHRQ's comprehensive review of non-opioid treatments for chronic pain. After 6mo, subjects will attempt to taper opioids for following 3 mo. Receives: Drug: Medication optimization; Other: Opioid tapering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid dose reduction + Pain response (binary: yes/no)
The primary outcome is a composite variable which combines one objective outcome (opioid dose reduction) and one subjective outcome (pain interference) to reflect two outcomes of equal importance to Veterans. Veterans will be considered as achieving this outcome if they experience 20% reduction in opioid daily dose (in MEDD) from baseline and no worsening of pain interference by more than 1 point on the Pain Enjoyment of Life and General Activity (PEG) score.
Measured: 9 months
Secondary outcomes (3)
Opioid dose
total daily opioid dose will be measured in MEDD and based upon prescription tracking records and adjusted based upon self-report in the patient's diary.
Measured: 9 months
Pain interference
Pain interference will be measured using PROMIS Pain Interference 6b measure
Measured: 9 months
Pain intensity
Pain intensity will be measured using a 0-10 Numeric Rating Scale
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start7 Oct 2025
- Primary completion1 Apr 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Karleen F Giannitrapani, PhD MA MPH, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CAMaria J Silveira, MD MA MPH, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574009
- Sponsor's protocol ID
- NURP-004-24S
- Other IDs
- I01CX002902-01
- Status last verified
- May 2026
- First submitted
- 23 Aug 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Options for Chronic Cancer Pain: a SMART Study
- ClinicalTrials.gov ID
- NCT06574009
- Acronym / sponsor ID
- NURP-004-24S
- Conditions
- Chronic Pain, Cancer Survivor, Opioid Dependence
- Keywords
- survivorship, chronic pain, analgesics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Aug 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 proposal is relevant to the 240,000 cancer survivors who continue to use opioids long after they have successfully completed treatment for cancer at the VHA, placing them at risk of opioid addiction and overdose, and other opioid-related problems. Yet, there are no programs at the VHA to help them find alternatives to opioids, nor evidence to inform the choice of interventions. This study will meet these needs by examining four interventions that are effective at reducing opioid use in patients with chronic musculoskeletal pain but have yet to be tested in cancer survivors on long term opioid therapy. The proposed work is relevant to the VHA Pain Office's mission to provide Veterans better pain management while limiting the risks of long-term opioid therapy and it aligns with VHA Research and Development's priority to examine clinical interventions for tapering opioids. Successful completion this project will keep VHA at the forefront of the battle against the opioid epidemic with a strategy that may be adapted to address the same needs in non-Veterans.
Detailed description
Background: Twenty-four percent of Veterans who survive cancer remain on long term opioid therapy (LTOT) after completing cancer treatment, placing them at significant risk of opioid addiction, overdose, and other opioid-related health conditions. To reduce opioid use in this population, the investigators will examine the impacts of multimodal pain care and buprenorphine rotation - two strategies that have demonstrated efficacy in Veterans with musculoskeletal pain on LTOT but have not been tested in cancer survivors on LTOT, revealing a critical knowledge gap. The overall scientific premise of this project is that these two approaches can effectively reduce LTOT in cancer survivors without worsening chronic pain, and that they are better than pain medication optimization and opioid tapering. The primary objective is to examine which treatment strategy or combination of strategies is most successful at achieving a reduction in LTOT without worsening chronic pain over 6 and 9 months. The investigators will also identify the key challenges and strategies in the implementation of each treatment strategy to facilitate future translation of study findings into VA practice.
Significance: There are currently no care pathways at the VHA to help cancer survivors on LTOT find alternatives to opioids for managing chronic pain, nor evidence to guide which interventions to include. By addressing these unmet needs, this work aligns with POU-AMP's priority to examine clinical interventions for tapering opioid medications.
Innovation: The investigators are among the first to examine multimodal care and buprenorphine rotation to reduce LTOT in cancer survivors. Also, the investigators are among the first to apply VHA's evidence-based, stepped care model of multidisciplinary pain care to cancer survivors on LTOT.
Aim 1: To test if Veterans who receive multimodal pain care will be more likely to decrease total daily opioid use by at least 20% at 6 and 9 months without experiencing worsened pain interference compared to those who receive optimization of non-opioid pain medications.
Aim 2: To test if Veterans who do not respond to 6 months of multimodal care or medication optimization are more likely to achieve the desired outcome at 9 months when they are offered buprenorphine rotation as opposed to opioid tapering.
Exploratory Aim 3: To examine which combination of interventions is most likely to achieve the desired outcome at 9 months.
Aim 4: To understand the key challenges and strategies in the implementation of each intervention to facilitate future translation of study findings into practice.
Methodology: The investigators plan a two-site, two-stage, response-adaptive, comparative effectiveness trial following SMART (Sequential, Multiple-Assignment Randomized Trial) principles. The investigators will enroll 294 Veteran cancer survivors on LTOT who receive their care at the Indianapolis or Ann Arbor VAMC. Subjects will be randomized to either multimodal pain care or pain medication optimization at Stage 1. After 6 months, non-respondents will be randomized to buprenorphine rotation or opioid tapering in Stage 2. The primary outcome is a composite variable combining one objective outcome (opioid dose reduction) and one subjective outcome (pain interference), assessed at 6 and 9 months. The secondary outcomes are opioid dose reduction and pain interference individually.
Next Steps/Implementation: Successful execution of this project will provide actionable information, including an implementation strategy, that VHA's Offices of Pain Management and Oncology can put in place to support over 240,000 cancer survivors on LTOT for chronic pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Multimodal pain care 9 months | Experimental | Behavioral: Multimodal pain careFindings from the comprehensive pain assessment will be used to inform an individualized, multimodal plan crafted by the team physician with the subject's collaboration |
| Medication optimization | Experimental | Behavioral: Multimodal pain care, Device: Buprenorphine rotationFindings from the comprehensive pain assessment will be used to inform a medication-focused pain plan. |
| Multimodal pain care 6 months / Opioid tapering 3 months | Experimental | Behavioral: Multimodal pain care, Other: Opioid taperingFindings from the comprehensive pain assessment will be used to inform an individualized, multimodal plan crafted by the team physician with the subject's collaboration. After 6 mo, subjects will attempt to taper opioids |
| Medication optimization 9 months | Experimental | Drug: Medication optimizationFindings from the comprehensive pain assessment will be used to inform a medication-focused pain plan. Medications will be optimized following an algorithm the investigators created based upon NCCN's Survivorship Guidelines and AHRQ's comprehensive review of non-opioid treatments for chronic pain. |
| Medication optimization 6 months/ Buprenorphine rotation 3 months | Experimental | Drug: Medication optimization, Device: Buprenorphine rotationFindings from the comprehensive pain assessment will be used to inform a medication-focused pain plan. Medications will be optimized following an algorithm the investigators created based upon NCCN's Survivorship Guidelines and AHRQ's comprehensive review of non-opioid treatments for chronic pain. After 6mo, subjects will receive buprenorphine and attempt to taper opioids for following 3 mo. |
| Medication optimization 6 months/ Opioid tapering 3 months | Experimental | Drug: Medication optimization, Other: Opioid taperingFindings from the comprehensive pain assessment will be used to inform a medication-focused pain plan. Medications will be optimized following an algorithm the investigators created based upon NCCN's Survivorship Guidelines and AHRQ's comprehensive review of non-opioid treatments for chronic pain. After 6mo, subjects will attempt to taper opioids for following 3 mo. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Veterans must have had a qualifying solid tumor (bladder, breast, colorectal, head and neck, liver, lung, pancreas, prostate, or urinary tract) without evidence of active disease for at least 6 months
- Participants must be 6 months away from their last receipt of cytotoxic, radiation, or surgical cancer treatments but can be on hormonal or biologic therapies needed to sustain remission or cancer control.
- Participants must report pain >=4 (on 0-10 NRS) on their last 3 recordings in the electronic medical record. Veterans should be on Long Term Opioid Therapy (LTOT) defined as:
- There must be advance agreement from their existing opioid prescriber to resume opioid prescribing after study
Key exclusion criteria (10 listed)
- Veterans with total daily opioid doses >= 300 Morphine Milligram Equivalents (MME) will be excluded (higher doses require tapering prior to rotation to buprenorphine, which is something the investigators do not want to examine in this study)
- Veterans with referrals or visits to a substance abuse clinic within the prior 2 years will be excluded to avoid including individuals requiring addiction expertise that is not available one the multidisciplinary pain teams
- The investigators will also exclude Veterans with:
- To ensure the relevance of our work to as many Veteran cancer survivors as possible, the investigators will not exclude subjects meeting DSM criteria for opioid use disorder if their only source of opioids is the VA
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 |
|---|---|---|
| Multimodal pain careBehavioral therapy (as below), physical therapy, assistive devices (e.g. TENS, bracing), referrals to VA specialists (e.g. interventional pain), and complementary and integrative therapies (e.g. acupuncture or massage | Behavioural | Medication optimization, Multimodal pain care 6 months / Opioid tapering 3 months, Multimodal pain care 9 months |
| Medication optimizationMedications will be optimized following an algorithm the investigators created based upon NCCN's Survivorship Guidelines and AHRQ's comprehensive review of non-opioid treatments for chronic pain. | Drug | Medication optimization 6 months/ Buprenorphine rotation 3 months, Medication optimization 6 months/ Opioid tapering 3 months, Medication optimization 9 months |
| Buprenorphine rotationSubjects randomized to this arm at 6 months will be offered the chance to rotate from their full mu agonist opioid to buprenorphine using a standardized protocol | Device | Medication optimization, Medication optimization 6 months/ Buprenorphine rotation 3 months |
| Opioid taperingSubjects randomized to tapering will receive recommendations based upon the VA PBM's opioid tapering reference guide | Other | Medication optimization 6 months/ Opioid tapering 3 months, Multimodal pain care 6 months / Opioid tapering 3 months |
Primary outcome
Opioid dose reduction + Pain response (binary: yes/no)
Time frame: 9 months
The primary outcome is a composite variable which combines one objective outcome (opioid dose reduction) and one subjective outcome (pain interference) to reflect two outcomes of equal importance to Veterans. Veterans will be considered as achieving this outcome if they experience 20% reduction in opioid daily dose (in MEDD) from baseline and no worsening of pain interference by more than 1 point on the Pain Enjoyment of Life and General Activity (PEG) score.
3 secondary outcomes
Opioid dose
Time frame: 9 months
Pain interference
Time frame: 9 months
Pain intensity
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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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.
Karleen F Giannitrapani, PhD MA MPH principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
Maria J Silveira, MD MA MPH principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Multimodal pain care, Medication optimization and Buprenorphine rotation in people with Chronic Pain and Cancer Survivor, run by VA Office of Research and Development at 2 sites 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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria J Silveira, MD MA MPH ((734) 845-3502, Maria.Silveira2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid dose reduction + Pain response (binary: yes/no) (time frame: 9 months). 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 11 May 2026.