Smoking CessationEarly Phase 1ECHONCT06602076
Developing Empowering Smoking Cessation
A Early Phase 1 study testing ECHO (Empowering Our Community & Health Outcomes) in people with Smoking Cessation, run by University of Oklahoma.
Trial summary
Problem: Despite encouraging use declines in the U.S. population, tobacco is still a leading cause of preventable disease and death. Current cessation treatments have limited success; two-thirds relapse within 6 months of a quit attempt. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- ECHO (Empowering Our Community & Health Outcomes)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Jul 2027
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sexual and/or gender minority (SGM)-identified
- Adults (i.e., ≥ 18 years old)
- Currently smoking cigarettes
- Living in a high stigma environment in the U.S.
- Able to read English at \> 6th-grade level
- Individuals with serious psychological distress (i.e., score of 13 ≥ 18 on the Kessler PD Scale-6 19) will be excluded from all Aims because of likelihood of functional impairments that substantially interfere with one or more major life activities.
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- Aim 3 (Pilot RCT) inclusion criteria will be:
- (1) ≥ 18 years old
- (2) sexual and/or gender minority-identified (see definition above)
- (3) living in Oklahoma or one of the 8 counties in San Joaquin Valley, California (verified by address)
- (4) a current cigarette smoker (see definition above)
- (5) willing to quit smoking within 30 days of enrollment (see definition above)
- (6) own a smartphone
- (7) ability to read English at \> 6th-grade level (see definition above)
- have no NRT contraindications
- (8) ≥ weekly internet access
- (9) willing and able to participate in SGM-serving volunteer activities.
- Aim 3 (Pilot RCT) exclusion criteria: Individuals will be excluded if currently using other smoking cessation treatments.
- Sexual minority identity will be indicated by selecting any non-heterosexual response option(s) from: Heterosexual (Straight); Gay or Lesbian; Bisexual; Something else (please state)." Participants will indicate the sex assigned on their birth certificate (i.e., natal sex). Gender minority identity will be indicated by "Trans male/Trans man;" "Trans female/Trans woman;" "Gender queer/Gender non-conforming;" "Different identity (please state)" or a binary identity (male or female) non-concordant with natal sex. Current cigarette smoking will be indicated by ≥100 lifetime cigarettes and currently smoking cigarettes "every day" or "some days". High SGM stigma states are defined as the 22 states wherein ˂60% of the population 'thinks that homosexuality should be accepted'.21 High SGM stigma municipalities are defined as one of the 246 U.S. municipalities (out of the 496 scored from all U.S. states) that scored below the median (71) on the HRC Municipal Equality Index. Willingness to quit smoking will be assessed with a single item: "Are you willing to quit smoking cigarettes within 30 days after enrolling in this study? (yes/no)". To be classified as 'ready to quit smoking,' participants will report readiness to quit in the next 30 days and at least 1 past-year quit attempt (i.e., in the "Preparation" stage of change).
- An equal number of female and male participants (i.e., natal sex) will be recruited so as to examine sex as a biological factor. Recruitment targets will aim to reflect the racial/ethnic composition of the populations from which the samples are drawn.
Who cannot join
None listed.
About this study
Official title: Developing an Empowerment Theory-Based Smoking Cessation Intervention for People With High Levels of Social Stress
Problem: Despite encouraging use declines in the U.S. population, tobacco is still a leading cause of preventable disease and death. Current cessation treatments have limited success; two-thirds relapse within 6 months of a quit attempt. Existing smoking cessation interventions overwhelmingly focus on within-person processes of behavior change rather than socioenvironmental influences on cessation success. Cessation interventions based on evidence linking social stress to increased nicotine dependence and relapse risk are needed to address the stressors people who smoke encounter while navigating their social environments (i.e., social stress). Effective empowering approaches for infectious disease prevention and youth tobacco use suggest that Empowerment Theory may also enhance smoking cessation assistance for people experiencing high levels of social stress.
Hypothesis: Our hypothesis is that when people participate in community-serving volunteer activities, they may also experience cognitive and behavioral changes (i.e., enhanced stress coping, social support, self-worth, prosociality) that ameliorate the effects of social stress, thereby supporting smoking cessation.
Importance: Empowerment Theory-informed health behavior change approaches have worked for infectious disease prevention and youth tobacco interventions. Our pretest (N=20; Oklahoma) demonstrated the feasibility and acceptability of volunteer activity participation as an adjunct to standard smoking cessation treatment. This novel smoking cessation intervention uses an innovative, theory-based, local-yet-scalable approach to enhance individual outcomes through community engagement. To ensure scalability and accessibility of this remotely delivered intervention, we will utilize the NIH-supported Dissemination and Implementation (D\&I) science framework, the Practical, Robust Implementation and Sustainability Model (PRISM), which is the contextually expanded version of RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance). This project will advance efforts to understand and address high tobacco use among people experiencing high levels of social stress and will inform a future R01 application for a fully-powered, multi-site RCT of ECHO aiming to end tobacco use across the U.S. while supporting community connectedness.
Read the detailed description
Specific Aims
Aim 1 (Inform): Prioritize factors associated with smoking cessation for people with high levels of social stress to inform volunteer activity protocol development for ECHO. We will use smartphone-administered ecological momentary assessment (EMA) to observe a 28-day naturalistic cessation attempt with N=60 adults with high levels of social stress recruited nationally. We will assess daily cessation-related experiences and behaviors, including evidence-based cessation factors (e.g., stress coping). These factors likely fluctuate within and across days, requiring EMA. Hypothesis: Stress coping, social support, self-worth, and prosociality will be associated with within- and day-level smoking abstinence, with largest effect sizes for social support and self-worth.
Aim 2 (Develop): Develop volunteer activity protocols likely to maximize smoking cessation success for people with high levels of social stress. With findings on prioritized cessation factors from Aim 1, our community partners, and our pretesting experience, we will develop a set of online volunteer activities that support participants' communities and harness key evidence-based cessation-promoting factors. Activities will be iteratively tested and refined with feedback from N=12 adults with high levels of social stress and volunteer activity facilitators in OK and SJV. These will form the basis of ECHO's refined core protocol that can be readily adapted in future intervention iterations.
Aim 3 (Pilot): Determine the feasibility, acceptability, and associations with quit self-efficacy and motivation of the developed ECHO protocol in two pilot sites. In a 2-arm, 12-week pilot randomized controlled trial (RCT) with Week 24 follow up, N=50 adults from OK and SJV with high levels of social stress who are willing to quit smoking will be randomized to receive either the NCI's quitSTART smoking cessation smartphone app46 and free nicotine replacement therapy (NRT; control, n=25), or quitSTART and NRT plus ECHO, which includes online community-serving volunteer activities (≥4 sessions) and a digital hub (Reddit) to foster social support across sites. Key feasibility outcomes assessed at Week 12 include: intervention acceptability, quitSTART app engagement, NRT adherence, quit self-efficacy and motivation, smoking behavior, and cessation-promoting factors that we aim to activate with the volunteer activity protocols. Community partner outcomes will include volunteer hours and organizational visibility as assessed by participant records and key informant interviews. We will identify characteristics across volunteer activity protocols that best activated cessation-related factors.
- Conditions
- Smoking Cessation
- Being tested
- ECHO (Empowering Our Community & Health Outcomes)
- Keywords
- tobacco use, smoking cessation, stress, social support, community engaged
- Medical subject headings
- Smoking Cessation, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECHO (Empowering Our Community & Health Outcomes)Behavioural
Additive intervention design wherein study participants receive remotely-delivered standard smoking cessation support (i.e., behavioral support plus nicotine replacement therapy) and engage in community-serving volunteer activities.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Receive standard smoking cessation treatment in the form of the NCI's quitSTART smoking cessation smartphone app and free over-the-counter nicotine replacement therapy provided by mail, plus participate in online community-serving volunteer activities (≥4 sessions) and a digital hub (Reddit) to foster social support across sites. Receives: Behavioral: ECHO (Empowering Our Community & Health Outcomes) |
| Control | No intervention | Receive standard smoking cessation treatment in the form of the NCI's quitSTART smoking cessation smartphone app and free over-the-counter nicotine replacement therapy provided by mail. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
BENCHMARK:
Retention at week 12 (minimum 80%)
Measured: 12 weeks
Intervention feasibility
The following post-intervention outcome will be assessed at Week 12: Overall intervention feasibility will be assessed by the Weiner scale (2017), which has four 5-point Likert-scale questions; higher score indicates greater feasibility.
BENCHMARK:
Intervention feasibility at Week 12 (70% or more of participants with an average score of 4 or greater on each scale).
Measured: 12 weeks
Intervention acceptability
The following post-intervention outcome will be assessed at Week 12: Overall intervention acceptability will be assessed by the Weiner scale (2017), which has four 5-point Likert-scale questions; higher score indicates greater acceptability.
BENCHMARK:
Intervention acceptability at Week 12 (70% or more of participants with an average score of 4 or greater on each scale).
Measured: 12 weeks
Intervention appropriateness
The following post-intervention outcome will be assessed at Week 12: Overall intervention appropriateness will be assessed by the Weiner scale (2017), which has four 5-point Likert-scale questions; higher score indicates greater appropriateness.
BENCHMARK:
Intervention appropriateness at Week 12 (70% or more of participants with an average score of 4 or greater on each scale).
Measured: 12 weeks
Secondary outcomes (5)
Self-reported smoking abstinence assessed at Week 12
-Self-reported 7-day Point Prevalence Abstinence (PPA)
Measured: 12 weeks
Self-efficacy asssessed at Week 12
-Self-Efficacy Scale/Confidence (SESC)
Measured: 12 weeks
Motivation to quit smoking assessed at Week 12
-Motivation to change (Stages of Change [SoC] scale)
Measured: 12 weeks
Smoking intensity assessed at Week 12
-Smoking intensity will be assessed by past-week smoking days and past-week cigarettes per smoking day.
Measured: 12 weeks
Cessation Treatment Engagement assessed at Week 12
-Engagement with smoking cessation treatment will be the number of days the participant opened the quitSTART app during the 12-week intervention period according to objective -tracking of app feature use. Greater number of days indicates greater engagement.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startAug 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Why it stopped: Early termination of federal grant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In a 2-arm, 12-week pilot randomized controlled trial (RCT) with Week 24 follow up, N=50 adults willing to quit smoking from Oklahoma (OK) and the San Joaquin Valley (SJV) in California will be randomized to receive either the NCI's quitSTART smoking cessation smartphone app and free nicotine replacement therapy (NRT; control, n=25), or quitSTART and NRT plus ECHO, which includes online community-serving volunteer activities (≥4 sessions) and a digital hub (Reddit) to foster social support across sites.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Julia M McQuoid, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602076
- Sponsor's protocol ID
- 17583W
- Other IDs
- 1R34DA060534-01A1
- Acronym
- ECHO
- Status last verified
- May 2026
- First submitted
- 9 Sep 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All dataset(s) that can be shared will be deposited in the Inter-university Consortium for Political and Social Science Research (ICPSR) data archive; a unit within the Institute for Social Research at the University of Michigan with offices in Ann Arbor. Should availability of this Consortium change during the course of the project an NIH-supported data repository will be used. The ICPSR data archive provides metadata, persistent identifiers (i.e., Digital Object Identifiers or DOI) and long-term access. ICPSR hosts data in a repository with powerful search capabilities. This repository is supported by the University of Michigan's Institute for Social Research and datasets are available through a request process.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Empowerment Theory-Based Smoking Cessation Intervention for People With High Levels of Social Stress
- ClinicalTrials.gov ID
- NCT06602076
- Acronym / sponsor ID
- ECHO / 17583W
- Conditions
- Smoking Cessation
- Keywords
- tobacco use, smoking cessation, stress, social support, community engaged
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Early termination of federal grant.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Sep 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.
Problem: Despite encouraging use declines in the U.S. population, tobacco is still a leading cause of preventable disease and death. Current cessation treatments have limited success; two-thirds relapse within 6 months of a quit attempt. Existing smoking cessation interventions overwhelmingly focus on within-person processes of behavior change rather than socioenvironmental influences on cessation success. Cessation interventions based on evidence linking social stress to increased nicotine dependence and relapse risk are needed to address the stressors people who smoke encounter while navigating their social environments (i.e., social stress). Effective empowering approaches for infectious disease prevention and youth tobacco use suggest that Empowerment Theory may also enhance smoking cessation assistance for people experiencing high levels of social stress.
Hypothesis: Our hypothesis is that when people participate in community-serving volunteer activities, they may also experience cognitive and behavioral changes (i.e., enhanced stress coping, social support, self-worth, prosociality) that ameliorate the effects of social stress, thereby supporting smoking cessation.
Importance: Empowerment Theory-informed health behavior change approaches have worked for infectious disease prevention and youth tobacco interventions. Our pretest (N=20; Oklahoma) demonstrated the feasibility and acceptability of volunteer activity participation as an adjunct to standard smoking cessation treatment. This novel smoking cessation intervention uses an innovative, theory-based, local-yet-scalable approach to enhance individual outcomes through community engagement. To ensure scalability and accessibility of this remotely delivered intervention, we will utilize the NIH-supported Dissemination and Implementation (D\&I) science framework, the Practical, Robust Implementation and Sustainability Model (PRISM), which is the contextually expanded version of RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance). This project will advance efforts to understand and address high tobacco use among people experiencing high levels of social stress and will inform a future R01 application for a fully-powered, multi-site RCT of ECHO aiming to end tobacco use across the U.S. while supporting community connectedness.
Detailed description
Specific Aims
Aim 1 (Inform): Prioritize factors associated with smoking cessation for people with high levels of social stress to inform volunteer activity protocol development for ECHO. We will use smartphone-administered ecological momentary assessment (EMA) to observe a 28-day naturalistic cessation attempt with N=60 adults with high levels of social stress recruited nationally. We will assess daily cessation-related experiences and behaviors, including evidence-based cessation factors (e.g., stress coping). These factors likely fluctuate within and across days, requiring EMA. Hypothesis: Stress coping, social support, self-worth, and prosociality will be associated with within- and day-level smoking abstinence, with largest effect sizes for social support and self-worth.
Aim 2 (Develop): Develop volunteer activity protocols likely to maximize smoking cessation success for people with high levels of social stress. With findings on prioritized cessation factors from Aim 1, our community partners, and our pretesting experience, we will develop a set of online volunteer activities that support participants' communities and harness key evidence-based cessation-promoting factors. Activities will be iteratively tested and refined with feedback from N=12 adults with high levels of social stress and volunteer activity facilitators in OK and SJV. These will form the basis of ECHO's refined core protocol that can be readily adapted in future intervention iterations.
Aim 3 (Pilot): Determine the feasibility, acceptability, and associations with quit self-efficacy and motivation of the developed ECHO protocol in two pilot sites. In a 2-arm, 12-week pilot randomized controlled trial (RCT) with Week 24 follow up, N=50 adults from OK and SJV with high levels of social stress who are willing to quit smoking will be randomized to receive either the NCI's quitSTART smoking cessation smartphone app46 and free nicotine replacement therapy (NRT; control, n=25), or quitSTART and NRT plus ECHO, which includes online community-serving volunteer activities (≥4 sessions) and a digital hub (Reddit) to foster social support across sites. Key feasibility outcomes assessed at Week 12 include: intervention acceptability, quitSTART app engagement, NRT adherence, quit self-efficacy and motivation, smoking behavior, and cessation-promoting factors that we aim to activate with the volunteer activity protocols. Community partner outcomes will include volunteer hours and organizational visibility as assessed by participant records and key informant interviews. We will identify characteristics across volunteer activity protocols that best activated cessation-related factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- In a 2-arm, 12-week pilot randomized controlled trial (RCT) with Week 24 follow up, N=50 adults willing to quit smoking from Oklahoma (OK) and the San Joaquin Valley (SJV) in California will be randomized to receive either the NCI's quitSTART smoking cessation smartphone app and free nicotine replacement therapy (NRT; control, n=25), or quitSTART and NRT plus ECHO, which includes online community-serving volunteer activities (≥4 sessions) and a digital hub (Reddit) to foster social support across sites.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: ECHO (Empowering Our Community & Health Outcomes)Receive standard smoking cessation treatment in the form of the NCI's quitSTART smoking cessation smartphone app and free over-the-counter nicotine replacement therapy provided by mail, plus participate in online community-serving volunteer activities (≥4 sessions) and a digital hub (Reddit) to foster social support across sites. |
| Control | No intervention | –Receive standard smoking cessation treatment in the form of the NCI's quitSTART smoking cessation smartphone app and free over-the-counter nicotine replacement therapy provided by mail. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Sexual and/or gender minority (SGM)-identified
- Adults (i.e., ≥ 18 years old)
- Currently smoking cigarettes
- Living in a high stigma environment in the U.S.
- Able to read English at \> 6th-grade level
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ECHO (Empowering Our Community & Health Outcomes)Additive intervention design wherein study participants receive remotely-delivered standard smoking cessation support (i.e., behavioral support plus nicotine replacement therapy) and engage in community-serving volunteer activities. | Behavioural | Treatment |
Primary outcome
Retention
Time frame: 12 weeks
BENCHMARK: Retention at week 12 (minimum 80%)
Intervention feasibility
Time frame: 12 weeks
The following post-intervention outcome will be assessed at Week 12: Overall intervention feasibility will be assessed by the Weiner scale (2017), which has four 5-point Likert-scale questions; higher score indicates greater feasibility. BENCHMARK: Intervention feasibility at Week 12 (70% or more of participants with an average score of 4 or greater on each scale).
Intervention acceptability
Time frame: 12 weeks
The following post-intervention outcome will be assessed at Week 12: Overall intervention acceptability will be assessed by the Weiner scale (2017), which has four 5-point Likert-scale questions; higher score indicates greater acceptability. BENCHMARK: Intervention acceptability at Week 12 (70% or more of participants with an average score of 4 or greater on each scale).
Intervention appropriateness
Time frame: 12 weeks
The following post-intervention outcome will be assessed at Week 12: Overall intervention appropriateness will be assessed by the Weiner scale (2017), which has four 5-point Likert-scale questions; higher score indicates greater appropriateness. BENCHMARK: Intervention appropriateness at Week 12 (70% or more of participants with an average score of 4 or greater on each scale).
5 secondary outcomes
Self-reported smoking abstinence assessed at Week 12
Time frame: 12 weeks
Self-efficacy asssessed at Week 12
Time frame: 12 weeks
Motivation to quit smoking assessed at Week 12
Time frame: 12 weeks
Smoking intensity assessed at Week 12
Time frame: 12 weeks
Cessation Treatment Engagement assessed at Week 12
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Yes. All dataset(s) that can be shared will be deposited in the Inter-university Consortium for Political and Social Science Research (ICPSR) data archive; a unit within the Institute for Social Research at the University of Michigan with offices in Ann Arbor. Should availability of this Consortium change during the course of the project an NIH-supported data repository will be used. The ICPSR data archive provides metadata, persistent identifiers (i.e., Digital Object Identifiers or DOI) and long-term access. ICPSR hosts data in a repository with powerful search capabilities. This repository is supported by the University of Michigan's Institute for Social Research and datasets are available through a request process.
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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.
Julia M McQuoid, PhD principal investigator
Associate Professor
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ECHO (Empowering Our Community & Health Outcomes) in people with Smoking Cessation, run by University of Oklahoma.
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 20 inclusion and 0 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: withdrawn, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Retention (time frame: 12 weeks). The study lists 4 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 7 May 2026.