Chronic PainTREETOPNCT06855732
Pain Self-Management and Treatment Engagement for Patients Taking Opioids
A study testing Pain Self-Management in people with Chronic Pain and Opioid Use Disorder, run by University of Pittsburgh at 17 sites in United States.
Trial summary
The goal of this study is to learn if Pain Self-Management (PSM) can improve chronic pain care in individuals with opioid misuse or opioid use disorder (OUD) The main questions it aims to answer are: Does PSM help participants manage their chronic pain more effectively? Does PSM help participants engage in treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Opioid Use Disorder, Opioid Misuse and Addiction
- What is being tested?
- Pain Self-Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 17 sitesUnited States
- Study dates
- 25 Nov 2024to 21 Jan 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Adults at least 18 years old
- Ability to speak, read, and understand English
- Capable of providing informed consent
- Access to phone and/or internet
- Current (defined as at least 1 primary care visit in the past 3 years) or new (confirmed appointment) primary care patient at a participating clinic
Show all 11Show fewer
- Must meet criteria for OUD or opioid misuse based on at least one of the following:
- OUD Misuse Screening score of 3 or more (sometimes or more) on at least one of the questions
- Meets criteria for DSM-5 Opioid Use Disorder on MINI-J
- Documented diagnosis of Opioid use Disorder (OUD)
- Have bothersome (Grade 2) or high impact chronic pain (Grade 3), based on the Graded Chronic Pain Scale-Revised (GCPS-R)
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Under 18 years of age
- Have cancer-related pain
- Are currently in jail, prison, overnight/residential facility as required by court of law or have pending legal action that could prevent participation in study activities
- Have received prescribed, administered, or dispensed MOUD (buprenorphine, methadone, naltrexone) as maintenance treatment for OUD (excluding acute or short-term (< 7 days) use of these medications to manage opioid withdrawal or pain management) within the past 90 days
- Had an intentional suicide attempt within the past 3 months
- The investigators will not exclude individuals with common comorbidities, such as depression, anxiety, or alcohol, methamphetamine, and other substance use disorders.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Renaissance Family Practice - Hampton Office
Allison Park, Pennsylvania, 15101
Comprehensive Care Practice
Baltimore, Maryland, 21224
Renaissance Family Practice - RIDC Office
Blawnox, Pennsylvania, 15238
St. Joseph's Rural Health Clinic (WVU Medicine)
Buckhannon, West Virginia, 26201
Renaissance Family Practice - Glenshaw Office
Glenshaw, Pennsylvania, 15223
Harpers Ferry Family Medicine (WVU Medicine)
Harpers Ferry, West Virginia, 25425
WVU Medicine University Town Centre
Morgantown, West Virginia, 26501
Renaissance Family Practice - Millvale Office
Pittsburgh, Pennsylvania, 15209
Community Medicine, Inc.
Pittsburgh, Pennsylvania, 15213
UPMC General Internal Medicine-Montefiore
Pittsburgh, Pennsylvania, 15213
Renaissance Family Practice - Aspinwall Office
Pittsburgh, Pennsylvania, 15215
UPMC General Internal Medicine-Shadyside (Shea Medical Center)
Pittsburgh, Pennsylvania, 15232
Renaissance Family Practice - Harmarville Office
Pittsburgh, Pennsylvania, 15238
WVU Medicine Primary Care
Shepherdstown, West Virginia, 25419
UPMC General Internal Medicine-Turtle Creek
Turtle Creek, Pennsylvania, 15145
Renaissance Family Practice - Penn Hills Office
Verona, Pennsylvania, 15147
UPMC General Internal Medicine-South
West Mifflin, Pennsylvania, 15122
About this study
Official title: Pain Self-Management Intervention to Reduce Pain & Improve MOUD Engagement in Primary Care: A Randomized Trial
The goal of this study is to learn if Pain Self-Management (PSM) can improve chronic pain care in individuals with opioid misuse or opioid use disorder (OUD) The main questions it aims to answer are:
- Does PSM help participants manage their chronic pain more effectively?
- Does PSM help participants engage in treatment for opioid use?
Read more
Researchers will compare PSM to standard care to see if PSM is effective in managing chronic pain and engagement in treatment.
Participants will:
- Take part in the PSM program or receive standard care for 12 weeks after enrolling in the study
- Complete surveys every 3 months for 9 months (total of 4 visits)
Participants will receive compensation for participating in the study.
There are risks associated with participating in the study, including breach of confidentiality and psychological distress caused by discussing difficult topics.
Read the detailed description
This is randomized trial of a pain self-management (PSM) intervention for chronic pain tailored to individuals with opioid misuse or opioid use disorder (OUD) as compared to usual care. The investigators hypothesize that PSM will be effective in improving both reducing pain and improving MOUD engagement among individuals with co-occurring opioid misuse/OUD and chronic pain.
This is a multisite trial recruiting from primary care clinics located in Pennsylvania, West Virginia and Maryland.
Interventions: Participants will be randomized to either PSM or Usual Care.
Pain Self-Management (PSM): PSM is a manualized pain self-management behavioral intervention tailored to patients with chronic pain and opioid misuse/OUD. PSM consists of 10 intervention sessions delivered via phone or web-based communication platform. Sessions will be led by a staff interventionist.
Usual Care (UC): Usual care or "treatment as usual" refers to the standard of care that patient participants receive at their primary care clinic. The standard of care for patients is to discuss issues related to chronic pain and opioid use with their providers and to receive clinical care for these conditions.
Study Duration: ~27 months (18 months of recruitment + 9 months follow-up) Participant Duration: 9 months
- Being tested
- Usual Care, Pain Self-Management
- Keywords
- pain, opioid, primary care, behavioral health
- Medical subject headings
- Chronic Pain, Opioid-Related Disorders, Behavior, Addictive, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareBehavioural
Usual care refers to the standard of care that patients receive at their primary care clinic.
The standard of care for patients is to discuss chronic pain with their providers at their discretion, and for providers to offer buprenorphine for OUD and/or provide referrals to specialty addiction treatment programs in the local community.
Participants will continue to have access to usual care for chronic pain, which could include pain clinic visits, physical therapy, medication (e.g., gabapentin), and/or seeing a counselor, psychiatrist, or psychologist.
The study protocol will not interfere with usual clinical care.
Pain Self-ManagementBehavioural
PSM is a manualized behavioral intervention tailored to patients in primary care with opioid misuse/OUD. The PSM intervention that consists of ten sessions/modules.
Participants will be offered a total of 10 PSM sessions, delivered weekly over a 12-week intervention period starting from the date of study enrollment.
A trained staff interventionist will lead the 60-minute sessions using a participant study manual that outlines the content for all 10 sessions.
The first two sessions, "Introduction" and "Navigating Conversations About Opioids", are mandatory. Participants can choose the order of the remaining 8 sessions, prioritizing those they are most interested in. Additional session topics are: Stress Management and Your Pain, Relaxation Techniques to Help Your Pain, Thinking Differently About Your Pain, Sleeping Better to Help Your Pain, Physical Activity and Your Pain, Mood and Your Pain, and Communicating with Others.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Usual care refers to the standard of care that patients receive at their primary care clinic. Receives: Behavioral: Usual Care |
| Pain Self-Management (PSM) | Experimental | PSM is a manualized pain self-management behavioral intervention tailored to patients with chronic pain and opioid misuse/OUD. PSM consists of 10 intervention sessions delivered via phone or web-based communication platform. Sessions will be led by a staff interventionist. Receives: Behavioral: Pain Self-Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline
The PROMIS Pain Interference - Short Form 4a is a validated, self-report 4-item tool assessing pain interference over the past 7 days. The PROMIS SF v1.0 - Pain Interference 4a consists of 4 questions and uses a 5-point scale, ranging from 1 (not at all) to 5 (very much). The total raw score equals the sum the values of the response to each question. The raw score is converted to a T-score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like pain interference, a T-score of 60 is one SD worse than average. That is, a person has more problems with pain hindering activities. By comparison, a pain interference T-score of 40 is one SD better than average.
Change = 3 month score - baseline score
Measured: Baseline, 3 Months
Secondary outcomes (7)
Change from Baseline in Overall Pain as Assessed by the PEG at 3 months Post-baseline
The Pain, Enjoyment, and General Activity (PEG) Scale is a validated, self-report 3-item tool assessing pain intensity and interference over the past week. The PEG scale consists of 3 separate numerical scales. Each scale has ratings ranging from 0-10. The PEG score is calculated by averaging the three numbers; a higher score indicates greater pain.
Change = 3 month score - baseline score
Measured: Baseline, 3 Months
Change from Baseline in Pain Catastrophizing as Assessed by the Pain Catastrophizing Questionnaire-6-item at 3 months Post-baseline
The Pain Catastrophizing Scale is a validated, self-report 6-item tool assessing assess pain catastrophizing for chronic pain. The PCS-6 uses a 5-point scale, ranging from 0 (not at all) to 4 (all the time). The total score ranges from 0 to 24, with higher score representing greater catastrophic thinking.
Change = 3 month score - baseline score
Measured: Baseline, 3 Months
Proportion of Participants that Engage in MOUD Treatment at 3 months Post-baseline
Proportion of individuals who self-reported having filled a prescription for or were administered or dispensed any MOUD (methadone, buprenorphine, naltrexone)
Measured: Baseline, 3 Months
Number of Days Participants took MOUD at 6-months Post-baseline
MOUD: methadone, buprenorphine, naltrexone.
Measured by self-report and medical chart extraction.
Measured: 6 Months
Change from Baseline in Self-Efficacy at 3 months Post-baseline
Change in self-efficacy for managing symptoms as measured by the Pain Self-Efficacy Questionnaire (PSEQ).
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain. The PSEQ is applicable to all persisting pain presentation. It enquires into the level of self-efficacy regarding a range of functions, including household chores, socializing, work, as well as coping with pain without medication.
A raw score is presented with a range from 0 - 60, where high scores indicate greater levels of confidence in dealing with pain. High scores are strongly associated with clinically-significant functional levels and provide a useful gauge for evaluating outcomes in chronic pain patients.
Change = 3 month score - baseline score
Measured: Baseline, 3 Months
Number of Days Non-prescribed Opioids were Used in the past 30 days as Assessed by the Modified ASI at 3-months Post-baseline
The modified ASI is a validated, self-report tool which includes questions from the Addiction Severity Index section on drug and alcohol use and includes questions about specific opioids used. The number of days in the last 30 that a participant reports using heroin, fentanyl, and/or opioid analgesics (percocet, oxycodone, oxycontin, vicodin, dilaudid, hydrocodone, hydromorphone, morphine, or codeine) will be summed for the outcome "Number of days non-prescribed opioids were used in the past 30 days." Number of days may range from 0 to 90.
Measured: 3 Months
Total score on the IMPOWR Opioid Misuse Screening scale at 3 months Post-baseline
The IMPOWR Opioid Misuse Screening scale is an exploratory, self-report scale consisting of 4 questions about the use of prescribed pain medications. Each question response ranges from Never (0) to Almost Always (4) with a possible summed score ranging from 0 to 16, with higher scores indicating more severe misuse.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start25 Nov 2024
- Primary completion6 Aug 2026
- Study completion21 Jan 2027 (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 University of PittsburghThe 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
- Participants will be randomized 1:1 to either PSM or Usual Care. The intervention will be completed in 12 weeks and will take place between the baseline and 3-month (post-intervention) visit.
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Erin Winstanley, University of Pittsburgh
- Investigators
- Erin Winstanley, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855732
- Sponsor's protocol ID
- STUDY24080167
- Other IDs
- RM1DA055311
- Acronym
- TREETOP
- Status last verified
- Nov 2026
- First submitted
- 26 Feb 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will comply with the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/research/heal-public-access-data-sharing-policy) and data for this study will be available to the public through the IMPOWR Dissemination Education and Coordination Center (IDEA-CC) (https://heal.nih.gov/research/clinical-research/integrative-management-chronic-pain).
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Self-Management Intervention to Reduce Pain & Improve MOUD Engagement in Primary Care: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06855732
- Acronym / sponsor ID
- TREETOP / STUDY24080167
- Keywords
- pain, opioid, primary care, behavioral health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 6 Aug 2026 (actual)
- Study completion
- 21 Jan 2027 (estimated)
- First posted
- 4 Mar 2025 (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.
The goal of this study is to learn if Pain Self-Management (PSM) can improve chronic pain care in individuals with opioid misuse or opioid use disorder (OUD) The main questions it aims to answer are:
- Does PSM help participants manage their chronic pain more effectively?
- Does PSM help participants engage in treatment for opioid use?
Researchers will compare PSM to standard care to see if PSM is effective in managing chronic pain and engagement in treatment.
Participants will:
- Take part in the PSM program or receive standard care for 12 weeks after enrolling in the study
- Complete surveys every 3 months for 9 months (total of 4 visits)
Participants will receive compensation for participating in the study.
There are risks associated with participating in the study, including breach of confidentiality and psychological distress caused by discussing difficult topics.
Detailed description
This is randomized trial of a pain self-management (PSM) intervention for chronic pain tailored to individuals with opioid misuse or opioid use disorder (OUD) as compared to usual care. The investigators hypothesize that PSM will be effective in improving both reducing pain and improving MOUD engagement among individuals with co-occurring opioid misuse/OUD and chronic pain.
This is a multisite trial recruiting from primary care clinics located in Pennsylvania, West Virginia and Maryland.
Interventions: Participants will be randomized to either PSM or Usual Care.
Pain Self-Management (PSM): PSM is a manualized pain self-management behavioral intervention tailored to patients with chronic pain and opioid misuse/OUD. PSM consists of 10 intervention sessions delivered via phone or web-based communication platform. Sessions will be led by a staff interventionist.
Usual Care (UC): Usual care or "treatment as usual" refers to the standard of care that patient participants receive at their primary care clinic. The standard of care for patients is to discuss issues related to chronic pain and opioid use with their providers and to receive clinical care for these conditions.
Study Duration: ~27 months (18 months of recruitment + 9 months follow-up) Participant Duration: 9 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to either PSM or Usual Care. The intervention will be completed in 12 weeks and will take place between the baseline and 3-month (post-intervention) visit.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual CareUsual care refers to the standard of care that patients receive at their primary care clinic. |
| Pain Self-Management (PSM) | Experimental | Behavioral: Pain Self-ManagementPSM is a manualized pain self-management behavioral intervention tailored to patients with chronic pain and opioid misuse/OUD. PSM consists of 10 intervention sessions delivered via phone or web-based communication platform. Sessions will be led by a staff interventionist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Adults at least 18 years old
- Ability to speak, read, and understand English
- Capable of providing informed consent
- Access to phone and/or internet
Key exclusion criteria (7 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Under 18 years of age
- Have cancer-related pain
- Are currently in jail, prison, overnight/residential facility as required by court of law or have pending legal action that could prevent participation in study activities
- Have received prescribed, administered, or dispensed MOUD (buprenorphine, methadone, naltrexone) as maintenance treatment for OUD (excluding acute or short-term (< 7 days) use of these medications to manage opioid withdrawal or pain management) within the past 90 days
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 |
|---|---|---|
| Usual CareUsual care refers to the standard of care that patients receive at their primary care clinic. The standard of care for patients is to discuss chronic pain with their providers at their discretion, and for providers to offer buprenorphine for OUD and/or provide referrals to specialty addiction treatment programs in the local community. Participants will continue to have access to usual care for chronic pain, which could include pain clinic visits, physical therapy, medication (e.g., gabapentin), and/or seeing a counselor, psychiatrist, or psychologist. The study protocol will not interfere with usual clinical care. | Behavioural | Usual Care |
| Pain Self-ManagementPSM is a manualized behavioral intervention tailored to patients in primary care with opioid misuse/OUD. The PSM intervention that consists of ten sessions/modules. Participants will be offered a total of 10 PSM sessions, delivered weekly over a 12-week intervention period starting from the date of study enrollment. A trained staff interventionist will lead the 60-minute sessions using a participant study manual that outlines the content for all 10 sessions. The first two sessions, "Introduction" and "Navigating Conversations About Opioids", are mandatory. Participants can choose the order of the remaining 8 sessions, prioritizing those they are most interested in. Additional session topics are: Stress Management and Your Pain, Relaxation Techniques to Help Your Pain, Thinking Differently About Your Pain, Sleeping Better to Help Your Pain, Physical Activity and Your Pain, Mood and Your Pain, and Communicating with Others. | Behavioural | Pain Self-Management (PSM) |
Primary outcome
Change from Baseline in Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline
Time frame: Baseline, 3 Months
The PROMIS Pain Interference - Short Form 4a is a validated, self-report 4-item tool assessing pain interference over the past 7 days. The PROMIS SF v1.0 - Pain Interference 4a consists of 4 questions and uses a 5-point scale, ranging from 1 (not at all) to 5 (very much). The total raw score equals the sum the values of the response to each question. The raw score is converted to a T-score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like pain interference, a T-score of 60 is one SD worse than average. That is, a person has more problems with pain hindering activities. By comparison, a pain interference T-score of 40 is one SD better than average. Change = 3 month score - baseline score
7 secondary outcomes
Change from Baseline in Overall Pain as Assessed by the PEG at 3 months Post-baseline
Time frame: Baseline, 3 Months
Change from Baseline in Pain Catastrophizing as Assessed by the Pain Catastrophizing Questionnaire-6-item at 3 months Post-baseline
Time frame: Baseline, 3 Months
Proportion of Participants that Engage in MOUD Treatment at 3 months Post-baseline
Time frame: Baseline, 3 Months
Number of Days Participants took MOUD at 6-months Post-baseline
Time frame: 6 Months
Change from Baseline in Self-Efficacy at 3 months Post-baseline
Time frame: Baseline, 3 Months
Number of Days Non-prescribed Opioids were Used in the past 30 days as Assessed by the Modified ASI at 3-months Post-baseline
Time frame: 3 Months
Total score on the IMPOWR Opioid Misuse Screening scale at 3 months Post-baseline
Time frame: 3 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 3 Nov 2026.
- Individual participant dataSharing planned: Yes. This study will comply with the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/research/heal-public-access-data-sharing-policy) and data for this study will be available to the public through the IMPOWR Dissemination Education and Coordination Center (IDEA-CC) (https://heal.nih.gov/research/clinical-research/integrative-management-chronic-pain).
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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.
Erin Winstanley, PhD principal investigator
University of Pittsburgh
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Self-Management in people with Chronic Pain and Opioid Use Disorder, run by University of Pittsburgh at 17 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 11 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
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?
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 Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline (time frame: Baseline, 3 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 3 Nov 2026.