Chronic PainPOSITIVENCT04648228
Pain and Opioids: Integrated Treatment In Veterans
A study testing ACT+MBRP in people with Chronic Pain and Opioid-use Disorder, run by University of New Mexico at 4 sites in United States.
Trial summary
This trial will recruit veterans with chronic pain (N = 160) who are prescribed buprenorphine for the treatment of opioid use disorder (OUD). We seek to: (1) examine the efficacy of an integrated treatment to reduce pain interference (Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention [ACT +… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Chronic Pain, Opioid-use Disorder, Opioids; Harmful Use
- What is being tested?
- ACT+MBRP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2021to 31 Dec 2026
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stabilized on a dose of buprenorphine for a period of at least 1 month and less than six months. Buprenorphine stabilization will be defined as a consistent dose for at least 30 consecutive days.
- Willing to comply with all study procedures and be available for the duration of the study
- Male or female, aged 21 to 75 years.
- Enrolled as a patient in one of the participating VA Co-Occurring Disorders clinics.
- Presence of chronic pain for > 6 months in duration.
Who cannot join
- Current or past diagnosis of schizophrenia, delusional disorder, psychotic or dissociative disorders.
- Unable to read English.
- Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
New Mexico VA Healthcare System
Albuquerque, New Mexico, 87108
University of New Mexico
Albuquerque, New Mexico, 87131
San Francisco VA Health Care System
San Francisco, California, 94121
Puget Sound VA Healthcare System
Tacoma, Washington, 98493
About this study
Official title: Integrated Treatment for Veterans With Co-Occurring Chronic Pain and Opioid Use Disorder
This trial will recruit veterans with chronic pain (N = 160) who are prescribed buprenorphine for the treatment of opioid use disorder (OUD). We seek to: (1) examine the efficacy of an integrated treatment to reduce pain interference (Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention [ACT + MBRP]) compared to an education control (EC) consisting of a protocol-based series of education sessions concerning chronic pain, opioids, and buprenorphine use and (2) examine how theoretically-relevant treatment mechanisms of pain acceptance, engagement in values-based action, and opioid craving are related to treatment outcomes. Interventions will be delivered via the VA Video Connect telehealth modality.
Read the detailed description
There is compelling data that chronic pain and hazardous opioid use, considered individually, are significant and costly healthcare burdens in both veteran and nonveteran populations in the United States (US). When these two diagnoses are considered together, they appear to occur in a clinically significant proportion of patients. Further, opioid use disorder (OUD) interferes with chronic pain treatment outcomes and continued pain interferes with OUD outcomes treatment. While buprenorphine is effective for the treatment of pain and OUD, retention, relapse, and continued pain interference is not addressed through treatment with buprenorphine alone. Integrated treatments that target the key outcomes for both conditions, specifically pain's interference on functioning and opioid misuse/relapse, as developed in our prior work, allows for a parsimonious and efficacious way of providing treatment. Our recently completed pilot study indicated that such an integrated treatment was feasible and more effective than treatment as usual. To study this further, a multisite clinical trial comparing a three month integrated behavioral treatment that combines Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention, as compared to an education control will be conducted with 160 veterans recruited from three VA Health Care Systems who have been stabilized on buprenorphine for the treatment of OUD. To assess longer-term outcomes, participants will be followed for 1 year after completion of the 3 month intervention.
- Conditions
- Chronic Pain, Opioid-use Disorder, Opioids; Harmful Use
- Being tested
- ACT+MBRP, Education control
- 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.
ACT+MBRPBehavioural
Intervention is behavioral treatment group that combines Acceptance and Commitment Therapy (ACT) with Mindfulness-Based Relapse Prevention. The group focuses on living with long-term pain, ways to complete daily living activities when you experience pain, coping with opioid and other drug cravings, and training in mindfulness practices.
Education controlBehavioural
Education control is behavioral treatment group that combines pain patient education with opioid and other drug education. The group focuses on experiences of long-term pain, instructions on how to function with this pain, and facts about opioids and other drugs.
| Study group | Role | What they receive |
|---|---|---|
| ACT + MBRP | Experimental | Acceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP) group will follow a manualized clinical protocol. Treatment will include 12 weekly group-based sessions, each lasting 90 minutes. Group sizes will range from 3 to 8. ACT + MBRP will be delivered via the VA Video Connect telehealth platform. Receives: Behavioral: ACT+MBRP |
| Education Control (EC) | Active comparator | The EC group will follow a protocol that combines opioid education sessions and psychology-led pain education sessions that are offered as part of the interdisciplinary pain program. Specifically, education will include 12 group-based sessions, each lasting 60 to 90 minutes. Group sizes will range from 3 to 8. EC will be delivered via the VA Video Connect telehealth platform. Receives: Behavioral: Education control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain interference
Patient Reported Outcome Measurement Information System (PROMIS) Bank v1.0 Pain Interference- The National Institutes of Health (NIH) PROMIS toolkit measure for pain interference will be assessed via 8 items.
Measured: Post-Treatment (month 3)
Secondary outcomes (11)
Pain intensity
Pain intensity, including current and least/most/usual over the past week, will be assessed via a 0 (no pain) to 10 (maximum possible pain) Numerical Rating Scale.
Measured: Post-Treatment (month 3)
Change in pain intensity
Pain intensity, including current and least/most/usual over the past week, will be assessed via a 0 (no pain) to 10 (maximum possible pain) Numerical Rating Scale.
Measured: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Opioid misuse
Current Opioid Misuse Measure (COMM) - The COMM measures opioid misuse risk and opioid-related behaviors via 17 items.
Measured: Post-Treatment (month 3)
Depression
Patient Health Questionnaire 9 (PHQ-9) - The PHQ-9 will be used to assess depression via 9 self-report items.
Measured: Post-Treatment (month 3)
Change in depression
Patient Health Questionnaire 9 (PHQ-9) - The PHQ-9 will be used to assess depression via 9 self-report items.
Measured: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Pain-related Fear
Pain Anxiety Symptom Scale (PASS) - Pain-related fear is reliably related to increased pain-related distress and disability via 20 self-report items.
Measured: Post-Treatment (month 3)
Change in pain-related Fear
Pain Anxiety Symptom Scale (PASS) - Pain-related fear is reliably related to increased pain-related distress and disability via 20 self-report items.
Measured: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Alcohol and other drug use
Substance use over the past 7 days will be assessed via the Timeline Followback. Number of drinking days, number of days misusing substances, number of days of polysubstance use (using more than one substance), and drinks per drinking day will be calculated based on the number of days of drinking, number of days of substance misuse (where substance misuse is defined as non-prescribed opioids, non-prescribed other prescription drugs, illicit substances, and heavy drinking (4 or more drinks for women, 5 or more drinks for men)), and number of days of polysubstance use (defined as using more than one substance).
Measured: Post-Treatment (month 3)
Change in alcohol and other drug use
Substance use over the past 7 days will be assessed via the Timeline Followback. Number of drinking days, number of days misusing substances, number of days of polysubstance use (using more than one substance), and drinks per drinking day will be calculated based on the number of days of drinking, number of days of substance misuse (where substance misuse is defined as non-prescribed opioids, non-prescribed other prescription drugs, illicit substances, and heavy drinking (4 or more drinks for women, 5 or more drinks for men)), and number of days of polysubstance use (defined as using more than one substance).
Measured: Monthly.
Change in Pain interference
Patient Reported Outcome Measurement Information System (PROMIS) Bank v1.0 Pain Interference- The National Institutes of Health (NIH) PROMIS toolkit measure for pain interference will be assessed via 8 items.
Measured: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Change in opioid misuse
Current Opioid Misuse Measure (COMM) - The COMM measures opioid misuse risk and opioid-related behaviors via 17 items.
Measured: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start1 Jul 2021
- Primary completion16 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- This trial will determine the efficacy of an integrated Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention (ACT+MBRP) treatment program for veterans with co-occurring chronic pain and opioid use disorder (OUD) who are prescribed buprenorphine, compared to an education control (EC) consisting of pain, opioid, and buprenorphine education. To test the efficacy of ACT + MBRP compared to EC with regard to primary and secondary outcomes, participants will be randomized to one of 2 treatment arms and followed for a total of 15 months (3-month active treatment period, 6 month follow-up, 12 month follow-up). All study treatments will be delivered via the VA Video Connect telehealth platform.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Utah, Johns Hopkins University, Duke University, Vanderbilt University, Biomedical Research Institute of New Mexico, Seattle Institute for Biomedical and Clinical Research, Queen's University, Belfast, University of California, San Francisco, San Francisco VA Health Care System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648228
- Sponsor's protocol ID
- 1507090
- Other IDs
- 1UG3DA051241-01, A20-0217
- Acronym
- POSITIVE
- Status last verified
- Oct 2026
- First submitted
- 18 Jun 2020
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is expected that all data collected by award recipients and their collaborators, as part of the NIH Helping to End Addiction Long-term (HEAL) Initiative, will be shared with the NIH HEAL Initiative central data platform. Institutions who receive Data and/or Materials from this award for performance of activities under this award are required to use the Data and/or Materials only as outlined by the NIH HEAL Initiative, in a manner that is consistent with applicable state and federal laws and regulations, including any informed consent requirements and the terms of the institution's NIH funding.
Publications
Vowles KE, Witkiewitz K, Cusack KJ, Gilliam WP, Cardon KE, Bowen S, Edwards KA, McEntee ML, Bailey RW. Integrated Behavioral Treatment for Veterans With Co-Morbid Chronic Pain and Hazardous Opioid Use: A Randomized Controlled Pilot Trial. J Pain. 2020 Jul-Aug;21(7-8):798-807. doi: 10.1016/j.jpain.2019.11.007. Epub 2019 Nov 21.
PubMed 31760109Vowles KE, Witkiewitz K, Clarke E, Schmidt Z, Borsari B, Edwards KE, Korecki JR, Moniz-Lewis DI, Bondzie JA, Mullins C, Thoreson CI, Delacruz J, Wilkins CH, Nelson S, Delventura J, Henderson R, Katz A, Hua W, Watson E, Baxley C, Canlas BR, Pendleton T, Herbst E, Batki S. Rationale and design of a multisite randomized clinical trial examining an integrated behavioral treatment for veterans with co-occurring chronic pain and opioid use disorder: The pain and opioids integrated treatment in veterans (POSITIVE) trial. Contemp Clin Trials. 2023 Mar;126:107096. doi: 10.1016/j.cct.2023.107096. Epub 2023 Jan 21.
PubMed 36693589
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Treatment for Veterans With Co-Occurring Chronic Pain and Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04648228
- Acronym / sponsor ID
- POSITIVE / 1507090
- Conditions
- Chronic Pain, Opioid-use Disorder, Opioids; Harmful Use
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 157 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Utah, Johns Hopkins University, Duke University, Vanderbilt University, Biomedical Research Institute of New Mexico, Seattle Institute for Biomedical and Clinical Research, Queen's University, Belfast, University of California, San Francisco, San Francisco VA Health Care System
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Dec 2020 (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 trial will recruit veterans with chronic pain (N = 160) who are prescribed buprenorphine for the treatment of opioid use disorder (OUD). We seek to: (1) examine the efficacy of an integrated treatment to reduce pain interference (Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention [ACT + MBRP]) compared to an education control (EC) consisting of a protocol-based series of education sessions concerning chronic pain, opioids, and buprenorphine use and (2) examine how theoretically-relevant treatment mechanisms of pain acceptance, engagement in values-based action, and opioid craving are related to treatment outcomes. Interventions will be delivered via the VA Video Connect telehealth modality.
Detailed description
There is compelling data that chronic pain and hazardous opioid use, considered individually, are significant and costly healthcare burdens in both veteran and nonveteran populations in the United States (US). When these two diagnoses are considered together, they appear to occur in a clinically significant proportion of patients. Further, opioid use disorder (OUD) interferes with chronic pain treatment outcomes and continued pain interferes with OUD outcomes treatment. While buprenorphine is effective for the treatment of pain and OUD, retention, relapse, and continued pain interference is not addressed through treatment with buprenorphine alone. Integrated treatments that target the key outcomes for both conditions, specifically pain's interference on functioning and opioid misuse/relapse, as developed in our prior work, allows for a parsimonious and efficacious way of providing treatment. Our recently completed pilot study indicated that such an integrated treatment was feasible and more effective than treatment as usual. To study this further, a multisite clinical trial comparing a three month integrated behavioral treatment that combines Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention, as compared to an education control will be conducted with 160 veterans recruited from three VA Health Care Systems who have been stabilized on buprenorphine for the treatment of OUD. To assess longer-term outcomes, participants will be followed for 1 year after completion of the 3 month intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This trial will determine the efficacy of an integrated Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention (ACT+MBRP) treatment program for veterans with co-occurring chronic pain and opioid use disorder (OUD) who are prescribed buprenorphine, compared to an education control (EC) consisting of pain, opioid, and buprenorphine education. To test the efficacy of ACT + MBRP compared to EC with regard to primary and secondary outcomes, participants will be randomized to one of 2 treatment arms and followed for a total of 15 months (3-month active treatment period, 6 month follow-up, 12 month follow-up). All study treatments will be delivered via the VA Video Connect telehealth platform.
| Arm | Type | Receives |
|---|---|---|
| ACT + MBRP | Experimental | Behavioral: ACT+MBRPAcceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP) group will follow a manualized clinical protocol. Treatment will include 12 weekly group-based sessions, each lasting 90 minutes. Group sizes will range from 3 to 8. ACT + MBRP will be delivered via the VA Video Connect telehealth platform. |
| Education Control (EC) | Active comparator | Behavioral: Education controlThe EC group will follow a protocol that combines opioid education sessions and psychology-led pain education sessions that are offered as part of the interdisciplinary pain program. Specifically, education will include 12 group-based sessions, each lasting 60 to 90 minutes. Group sizes will range from 3 to 8. EC will be delivered via the VA Video Connect telehealth platform. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stabilized on a dose of buprenorphine for a period of at least 1 month and less than six months. Buprenorphine stabilization will be defined as a consistent dose for at least 30 consecutive days.
- Willing to comply with all study procedures and be available for the duration of the study
- Male or female, aged 21 to 75 years.
- Enrolled as a patient in one of the participating VA Co-Occurring Disorders clinics.
- Presence of chronic pain for > 6 months in duration.
Key exclusion criteria (3 listed)
- Current or past diagnosis of schizophrenia, delusional disorder, psychotic or dissociative disorders.
- Unable to read English.
- Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).
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 |
|---|---|---|
| ACT+MBRPIntervention is behavioral treatment group that combines Acceptance and Commitment Therapy (ACT) with Mindfulness-Based Relapse Prevention. The group focuses on living with long-term pain, ways to complete daily living activities when you experience pain, coping with opioid and other drug cravings, and training in mindfulness practices. | Behavioural | ACT + MBRP |
| Education controlEducation control is behavioral treatment group that combines pain patient education with opioid and other drug education. The group focuses on experiences of long-term pain, instructions on how to function with this pain, and facts about opioids and other drugs. | Behavioural | Education Control (EC) |
Primary outcome
Pain interference
Time frame: Post-Treatment (month 3)
Patient Reported Outcome Measurement Information System (PROMIS) Bank v1.0 Pain Interference- The National Institutes of Health (NIH) PROMIS toolkit measure for pain interference will be assessed via 8 items.
11 secondary outcomes
Pain intensity
Time frame: Post-Treatment (month 3)
Change in pain intensity
Time frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Opioid misuse
Time frame: Post-Treatment (month 3)
Depression
Time frame: Post-Treatment (month 3)
Change in depression
Time frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Pain-related Fear
Time frame: Post-Treatment (month 3)
Change in pain-related Fear
Time frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Alcohol and other drug use
Time frame: Post-Treatment (month 3)
Change in alcohol and other drug use
Time frame: Monthly.
Change in Pain interference
Time frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Change in opioid misuse
Time frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
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 30 Oct 2026.
- Background: PubMed 31760109Vowles KE, Witkiewitz K, Cusack KJ, Gilliam WP, Cardon KE, Bowen S, Edwards KA, McEntee ML, Bailey RW. Integrated Behavioral Treatment for Veterans With Co-Morbid Chronic Pain and Hazardous Opioid Use: A Randomized Controlled Pilot Trial. J Pain. 2020 Jul-Aug;21(7-8):798-807. doi: 10.1016/j.jpain.2019.11.007. Epub 2019 Nov 21.
- Derived from this study: PubMed 36693589Vowles KE, Witkiewitz K, Clarke E, Schmidt Z, Borsari B, Edwards KE, Korecki JR, Moniz-Lewis DI, Bondzie JA, Mullins C, Thoreson CI, Delacruz J, Wilkins CH, Nelson S, Delventura J, Henderson R, Katz A, Hua W, Watson E, Baxley C, Canlas BR, Pendleton T, Herbst E, Batki S. Rationale and design of a multisite randomized clinical trial examining an integrated behavioral treatment for veterans with co-occurring chronic pain and opioid use disorder: The pain and opioids integrated treatment in veterans (POSITIVE) trial. Contemp Clin Trials. 2023 Mar;126:107096. doi: 10.1016/j.cct.2023.107096. Epub 2023 Jan 21.
- Description of ACT+MBRP integrated treatment being tested in the current study.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. It is expected that all data collected by award recipients and their collaborators, as part of the NIH Helping to End Addiction Long-term (HEAL) Initiative, will be shared with the NIH HEAL Initiative central data platform. Institutions who receive Data and/or Materials from this award for performance of activities under this award are required to use the Data and/or Materials only as outlined by the NIH HEAL Initiative, in a manner that is consistent with applicable state and federal laws and regulations, including any informed consent requirements and the terms of the institution's NIH funding.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT+MBRP in people with Chronic Pain and Opioid-use Disorder, run by University of New Mexico at 4 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 5 inclusion and 3 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 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Pain interference (time frame: Post-Treatment (month 3)). 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 NCT04648228, which also lists 2 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 30 Oct 2026.