Tobacco SmokingPhase 3MINDSETNCT07039175
Intervention to Increase Intention to Change Alcohol/Tobacco Use in Veterans With Chronic Disease
A Phase 3 study testing MINDSET in people with Tobacco Smoking and Alcohol-Related Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Many Veterans who have chronic conditions like cardiovascular disease or diabetes smoke or drink too much alcohol, which can worsen the condition. Veterans are asked yearly about drinking/smoking and providers provide a brief advice discussion focused on behavior change. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Smoking, Alcohol-Related Disorders
- What is being tested?
- MINDSET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 30 Jun 2029
- Phase
- Phase 3
- 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
- an active diagnosis of diabetes, cardiovascular disease (CVD), or a cardiovascular risk factor (hypertension {HTN}, hyperlipidemia {HLD}) AND signs of reticence to change their smoking and/or alcohol use as evidenced by the two consecutive prior screens being positive for hazardous (e.g., Alcohol Use Disorders Test-Consumption [AUDC], and/or smoking (I.e., whether they are a current smoker or not).
- Confirmation of smoking and/or drinking status during telephone screening (e.g., Alcohol Use Disorders Test-Consumption [AUDC], and/or smoking (I.e., whether they are a current smoker or not).
- Veteran
- Age 18 years
- utilize VA for medical care more than 1 time per year
- are due to complete their smoking/alcohol use screen in approximately 3 months (to ensure they will likely receive UC during intervention period)
- a scheduled PC appointment within the intervention period.
Who cannot join
- dementia or severe cognitive impairment per Problem List
- significant visual impairment per Problem List
- Other Exclusion criteria assessed by study staff during screening/self-report are:
- inability to communicate or read in English;
- Hearing impairment; and
- cognitive impairment or screening for cognitive impairment (>=weighted score of 10 on Blessed screener).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, 14215-1129
Mary A Blake, (716) 862-6527, mary.blake@va.gov
Ali A El-Solh, MD MPH, (716) 862-6528, ali.el-solh@va.gov
About this study
Official title: A Low-Cost, High-Access Intervention to Increase Intention to Change Alcohol/Tobacco Use Among Reticent Veterans Who Are Non-Responders to Brief Advice at High Risk Due to Chronic Conditions
Many Veterans who have chronic conditions like cardiovascular disease or diabetes smoke or drink too much alcohol, which can worsen the condition. Veterans are asked yearly about drinking/smoking and providers provide a brief advice discussion focused on behavior change. However, many Veterans continue to drink or smoke, and are often not interested in higher-intensity, change-based referrals. The investigators recently piloted MINDSET, an intervention that fills this gap. MINDSET is a proactive, population-based intervention that uses a mailed packet with tailored education about how drinking/smoking relate to the Veteran's condition (heart conditions and/or diabetes), followed by a brief motivational call. The investigators will test MINDSET's effectiveness versus usual primary care on outcomes including intention to change and substance use and evaluate the relationships between these and other variables over time.
Read the detailed description
Background: Chronic diseases are prevalent, costly, and have been linked to increased risk of mortality and morbidity in Veterans. Hazardous alcohol use and cigarette smoking can significantly exacerbate these negative consequences for Veterans. To help mitigate risk, VHA primary care health initiatives have prioritized hazardous alcohol use and cigarette smoking and have mandated that patients be annually screened and receive a brief intervention (primary care intervention delivered by the patient-aligned care team; PACT) if positive. However, many Veterans continue to smoke and/or hazardously drink. Current VHA treatment options do not meet the needs of these reticent Veterans. Motivational Intervention Designed for Self-management and EducaTion (MINDSET) is an evidence-based, remote, low-resource intervention that uses a motivational approach to increase change intentions within the context of their chronic disease.
Significance: Most healthcare costs come from Veterans with chronic diseases (e.g., cardiovascular disease; CVD), which are worsened by hazardous alcohol use and smoking. This research addresses multiple VHA priorities through its focus on increasing access to care for a subgroup of reticent Veterans with chronic disease. MINDSET's integrated focus on smoking and hazardous drinking in the context of chronic disease management aligns with Veteran's priorities, and diabetes and CVD were a top ranked health concern by Veterans. This work is also very well aligned with several HSR\&D Priorities, including Complex Chronic Disease Management, Mental \& Behavioral Health, Women's Health, Aging, and Access to Care.
Innovation \& Impact: MINDSET's design, which recognizes the competing demands within medical settings, intentionally utilizes universal and accessible dissemination methods (e.g., mail and telephone) to decrease burden while increasing reach and impact. This study uniquely fills a gap in VHA and HSR\&D research as there are no evidence-based interventions tailored for this subgroup of reticent Veterans who smoke and/or drink above recommended limits and have co-occurring CVD, cardiac risk factors, and/or diabetes. The impact potential is high, as moving this subgroup of reticent Veterans toward changing smoking/hazardous drinking will dramatically decrease their health risks and healthcare costs.
Specific Aims: The proposed work will evaluate MINDSET+usual care (UC) in comparison to UC alone (brief primary care advice) on precursors to change (i.e., behavioral control, intention to change), and substance consumption.
Methodology: The investigators will conduct a type 1 hybrid effectiveness-implementation RCT, where enrolled Veterans will be randomized to either the intervention condition UC (i.e., primary care brief advice) alone or (usual care [UC]+MINDSET). Assessments will occur every 4 weeks, with comprehensive assessments every 3 months for one year. The investigators will utilize a stratified block randomization method based on whether Veterans report only smoking, only hazardously drinking, or both. The investigator's primary outcome will assess participants' intention to change each behavior separately, and a total summed score across items divided by the number of items endorsed (based on behaviors engaged in) will be utilized to summarize their overall intention to change. It is important to note that Veterans will be recruited nationally for this fully telehealth-based study.
Next Steps/Implementation: If MINDSET is effective, additional implementation research/efforts will be proposed.
- Conditions
- Tobacco Smoking, Alcohol-Related Disorders
- Being tested
- MINDSET, Usual Care
- Keywords
- Chronic Disease, Smoking, Drinking, Alcohol, Cardiovascular Risk, Health Behavior, Medicine, Behavioral, telehealth
- Medical subject headings
- Tobacco Smoking, Alcohol-Related Disorders, Chronic Disease, Smoking, Alcohol Drinking, Health Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINDSETBehavioural
Also called Motivational INtervention Designed for Self-management and EducaTion
A behavior-change model informed mailed informational packet with tailored health information regarding the impacts of smoking/drinking on chronic disease and the benefits of stopping, followed by a brief motivational telephone booster call from a behavioral health provider.
Usual CareOther
Also called UC
All Veterans involved in this study will have a standard primary care (PC) appointment, which may include conversations/interventions related to drinking and smoking. This appointment is not controlled by the study team and we cannot comment on the extent to which smoking/drinking will or will not be discussed in the primary care appointment but we imagine this can range from no discussion/intervention at all to extensive conversations with the provision of medications, brief advice, etc.
| Study group | Role | What they receive |
|---|---|---|
| MINDSET+UC | Experimental | Within one month following a standard primary care appointment (which comprises usual care; UC), Veterans in this condition will receive the MINDSET intervention which consists of: a behavior-change model informed mailed informational packet with tailored health information regarding the impacts of smoking/drinking on chronic disease and the benefits of stopping, followed by a brief motivational telephone booster call from a behavioral health provider. Receives: Behavioral: MINDSET |
| Usual Care | Active comparator | All Veterans in this study will have a primary care appointment during which their primary care team will administer whatever tobacco/alcohol use assessment and intervention they typically would. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Theory of Planned Behavior Intention subscale
3 items regarding intention to change measured on a 7-point Likert-type scale from (1) very unlikely to (7) very likely.
Measured: Baseline, 4-weeks, 8-weeks, 12-weeks, 16-weeks, 20-weeks, 24-weeks, 28-weeks, 32-weeks, 36-weeks, 40-weeks, 44-weeks, 48-weeks
Readiness to Change Ruler
A one-item 11-point (0-10) ruler with the following anchors: "I never think about my drinking/smoking" at 0 to "I now drink/smoke less than before" at 10
Measured: Baseline, 4-weeks, 8-weeks, 12-weeks, 16-weeks, 20-weeks, 24-weeks, 28-weeks, 32-weeks, 36-weeks, 40-weeks, 44-weeks, 48-weeks
Theory of Planned Behavior Perceived Behavioral Control Subscale
4 items measured on a 1-7 point Likert-type scale. The four items include two related to self-efficacy and two to controllability, as recommended by guidelines for developing TBP-related measurements.
Measured: Baseline, 4-weeks, 8-weeks, 12-weeks, 16-weeks, 20-weeks, 24-weeks, 28-weeks, 32-weeks, 36-weeks, 40-weeks, 44-weeks, 48-weeks
Secondary outcomes (4)
Timeline Followback
A verbal/guided measure that guides Veterans Veterans through the last 90 days reporting how many drinks or cigarettes they had each day.
Measured: Baseline, 12-weeks, 24-weeks, 36-weeks, 48-weeks
Theory of Planned Behavior Action Planning subscale
4 items (e.g., I have been thinking about when I'm going to change) that measure planning/action behaviors toward change based on TBP rated on a 7-point Likert-type scale from (1) completely wrong to (7) complete correct.
Measured: Baseline, 12-weeks, 24-weeks, 36-weeks, 48-weeks
Theory of Planned Behavior Quitting Behaviors subscale
3 dichotomous face-valid questions to assess the participants quitting/change behaviors (e.g., "I have quit") on a yes-no scale
Measured: Baseline, 12-weeks, 24-weeks, 36-weeks, 48-weeks
Readiness to Access Help scale plus Help-Seeking for Alcohol-Related Problems Scale
6-items that will be used to assess any help seeking behaviors (e.g., accessing self-help resources) that has already occurred on a 11-point Likert-scale. Two additional items adapted from the Help-Seeking for Alcohol-Related Problems in College Students Scale106 will be included attending group meetings and calling a counselor or doctor.
Measured: Baseline, 12-weeks, 24-weeks, 36-weeks, 48-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Oct 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco SmokingStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants recruited from VAs across the country will be randomized to receive usual care + MINDSET or usual care alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Julie Christina Gass, PhD, Principal investigator, VA Western New York Healthcare System, Buffalo, NYJennifer S Funderburk, PhD, Principal investigator, Syracuse VA Medical Center, Syracuse, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039175
- Sponsor's protocol ID
- IIR 23-170
- Other IDs
- 1IOHX003901
- Acronym
- MINDSET
- Status last verified
- Dec 2025
- First submitted
- 13 Jun 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Low-Cost, High-Access Intervention to Increase Intention to Change Alcohol/Tobacco Use Among Reticent Veterans Who Are Non-Responders to Brief Advice at High Risk Due to Chronic Conditions
- ClinicalTrials.gov ID
- NCT07039175
- Acronym / sponsor ID
- MINDSET / IIR 23-170
- Conditions
- Tobacco Smoking, Alcohol-Related Disorders
- Keywords
- Chronic Disease, Smoking, Drinking, Alcohol, Cardiovascular Risk, Health Behavior, Medicine, Behavioral, telehealth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 26 Jun 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.
Many Veterans who have chronic conditions like cardiovascular disease or diabetes smoke or drink too much alcohol, which can worsen the condition. Veterans are asked yearly about drinking/smoking and providers provide a brief advice discussion focused on behavior change. However, many Veterans continue to drink or smoke, and are often not interested in higher-intensity, change-based referrals. The investigators recently piloted MINDSET, an intervention that fills this gap. MINDSET is a proactive, population-based intervention that uses a mailed packet with tailored education about how drinking/smoking relate to the Veteran's condition (heart conditions and/or diabetes), followed by a brief motivational call. The investigators will test MINDSET's effectiveness versus usual primary care on outcomes including intention to change and substance use and evaluate the relationships between these and other variables over time.
Detailed description
Background: Chronic diseases are prevalent, costly, and have been linked to increased risk of mortality and morbidity in Veterans. Hazardous alcohol use and cigarette smoking can significantly exacerbate these negative consequences for Veterans. To help mitigate risk, VHA primary care health initiatives have prioritized hazardous alcohol use and cigarette smoking and have mandated that patients be annually screened and receive a brief intervention (primary care intervention delivered by the patient-aligned care team; PACT) if positive. However, many Veterans continue to smoke and/or hazardously drink. Current VHA treatment options do not meet the needs of these reticent Veterans. Motivational Intervention Designed for Self-management and EducaTion (MINDSET) is an evidence-based, remote, low-resource intervention that uses a motivational approach to increase change intentions within the context of their chronic disease.
Significance: Most healthcare costs come from Veterans with chronic diseases (e.g., cardiovascular disease; CVD), which are worsened by hazardous alcohol use and smoking. This research addresses multiple VHA priorities through its focus on increasing access to care for a subgroup of reticent Veterans with chronic disease. MINDSET's integrated focus on smoking and hazardous drinking in the context of chronic disease management aligns with Veteran's priorities, and diabetes and CVD were a top ranked health concern by Veterans. This work is also very well aligned with several HSR\&D Priorities, including Complex Chronic Disease Management, Mental \& Behavioral Health, Women's Health, Aging, and Access to Care.
Innovation \& Impact: MINDSET's design, which recognizes the competing demands within medical settings, intentionally utilizes universal and accessible dissemination methods (e.g., mail and telephone) to decrease burden while increasing reach and impact. This study uniquely fills a gap in VHA and HSR\&D research as there are no evidence-based interventions tailored for this subgroup of reticent Veterans who smoke and/or drink above recommended limits and have co-occurring CVD, cardiac risk factors, and/or diabetes. The impact potential is high, as moving this subgroup of reticent Veterans toward changing smoking/hazardous drinking will dramatically decrease their health risks and healthcare costs.
Specific Aims: The proposed work will evaluate MINDSET+usual care (UC) in comparison to UC alone (brief primary care advice) on precursors to change (i.e., behavioral control, intention to change), and substance consumption.
Methodology: The investigators will conduct a type 1 hybrid effectiveness-implementation RCT, where enrolled Veterans will be randomized to either the intervention condition UC (i.e., primary care brief advice) alone or (usual care [UC]+MINDSET). Assessments will occur every 4 weeks, with comprehensive assessments every 3 months for one year. The investigators will utilize a stratified block randomization method based on whether Veterans report only smoking, only hazardously drinking, or both. The investigator's primary outcome will assess participants' intention to change each behavior separately, and a total summed score across items divided by the number of items endorsed (based on behaviors engaged in) will be utilized to summarize their overall intention to change. It is important to note that Veterans will be recruited nationally for this fully telehealth-based study.
Next Steps/Implementation: If MINDSET is effective, additional implementation research/efforts will be proposed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants recruited from VAs across the country will be randomized to receive usual care + MINDSET or usual care alone.
| Arm | Type | Receives |
|---|---|---|
| MINDSET+UC | Experimental | Behavioral: MINDSETWithin one month following a standard primary care appointment (which comprises usual care; UC), Veterans in this condition will receive the MINDSET intervention which consists of: a behavior-change model informed mailed informational packet with tailored health information regarding the impacts of smoking/drinking on chronic disease and the benefits of stopping, followed by a brief motivational telephone booster call from a behavioral health provider. |
| Usual Care | Active comparator | Other: Usual CareAll Veterans in this study will have a primary care appointment during which their primary care team will administer whatever tobacco/alcohol use assessment and intervention they typically would. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- an active diagnosis of diabetes, cardiovascular disease (CVD), or a cardiovascular risk factor (hypertension {HTN}, hyperlipidemia {HLD}) AND signs of reticence to change their smoking and/or alcohol use as evidenced by the two consecutive prior screens being positive for hazardous (e.g., Alcohol Use Disorders Test-Consumption [AUDC], and/or smoking (I.e., whether they are a current smoker or not).
- Confirmation of smoking and/or drinking status during telephone screening (e.g., Alcohol Use Disorders Test-Consumption [AUDC], and/or smoking (I.e., whether they are a current smoker or not).
- Veteran
- Age 18 years
- utilize VA for medical care more than 1 time per year
Key exclusion criteria (6 listed)
- dementia or severe cognitive impairment per Problem List
- significant visual impairment per Problem List
- Other Exclusion criteria assessed by study staff during screening/self-report are:
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 |
|---|---|---|
| MINDSETAlso: Motivational INtervention Designed for Self-management and EducaTionA behavior-change model informed mailed informational packet with tailored health information regarding the impacts of smoking/drinking on chronic disease and the benefits of stopping, followed by a brief motivational telephone booster call from a behavioral health provider. | Behavioural | MINDSET+UC |
| Usual CareAlso: UCAll Veterans involved in this study will have a standard primary care (PC) appointment, which may include conversations/interventions related to drinking and smoking. This appointment is not controlled by the study team and we cannot comment on the extent to which smoking/drinking will or will not be discussed in the primary care appointment but we imagine this can range from no discussion/intervention at all to extensive conversations with the provision of medications, brief advice, etc. | Other | Usual Care |
Primary outcome
Theory of Planned Behavior Intention subscale
Time frame: Baseline, 4-weeks, 8-weeks, 12-weeks, 16-weeks, 20-weeks, 24-weeks, 28-weeks, 32-weeks, 36-weeks, 40-weeks, 44-weeks, 48-weeks
3 items regarding intention to change measured on a 7-point Likert-type scale from (1) very unlikely to (7) very likely.
Readiness to Change Ruler
Time frame: Baseline, 4-weeks, 8-weeks, 12-weeks, 16-weeks, 20-weeks, 24-weeks, 28-weeks, 32-weeks, 36-weeks, 40-weeks, 44-weeks, 48-weeks
A one-item 11-point (0-10) ruler with the following anchors: "I never think about my drinking/smoking" at 0 to "I now drink/smoke less than before" at 10
Theory of Planned Behavior Perceived Behavioral Control Subscale
Time frame: Baseline, 4-weeks, 8-weeks, 12-weeks, 16-weeks, 20-weeks, 24-weeks, 28-weeks, 32-weeks, 36-weeks, 40-weeks, 44-weeks, 48-weeks
4 items measured on a 1-7 point Likert-type scale. The four items include two related to self-efficacy and two to controllability, as recommended by guidelines for developing TBP-related measurements.
4 secondary outcomes
Timeline Followback
Time frame: Baseline, 12-weeks, 24-weeks, 36-weeks, 48-weeks
Theory of Planned Behavior Action Planning subscale
Time frame: Baseline, 12-weeks, 24-weeks, 36-weeks, 48-weeks
Theory of Planned Behavior Quitting Behaviors subscale
Time frame: Baseline, 12-weeks, 24-weeks, 36-weeks, 48-weeks
Readiness to Access Help scale plus Help-Seeking for Alcohol-Related Problems Scale
Time frame: Baseline, 12-weeks, 24-weeks, 36-weeks, 48-weeks
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 31 Dec 2025.
- 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.
Julie Christina Gass, PhD principal investigator
VA Western New York Healthcare System, Buffalo, NY
Jennifer S Funderburk, PhD principal investigator
Syracuse VA Medical Center, Syracuse, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MINDSET in people with Tobacco Smoking and Alcohol-Related Disorders, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 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 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Julie C Gass, PhD ((716) 834-9200 ext. 5429, Julie.Gass@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Theory of Planned Behavior Intention subscale (time frame: Baseline, 4-weeks, 8-weeks, 12-weeks, 16-weeks, 20-weeks, 24-weeks, 28-weeks, 32-weeks, 36-weeks, 40-weeks, 44-weeks, 48-weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.