Alcohol DrinkingFITSTART+NCT04549454
Parent Feedback Intervention Targeting Student Transitions and Alcohol Related Trajectories (+) Efficacy Study
A study testing FITSTART+ PBI and General Parenting Advice in people with Alcohol Drinking and Alcohol Problem Drinking, run by Loyola Marymount University at 1 site in United States.
Trial summary
FITSTART (Feedback Intervention Targeting Student Transitions and Risk Trajectories) is a parent-based social norms intervention that has been shown to reduce risky drinking in incoming first year students.This program uses normative feedback to correct parents overestimation of other parents negative alcohol-related… Read more about this study
- Who is it for?
- Ages 17 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Alcohol Problem Drinking, Parenting
- What is being tested?
- FITSTART+ PBI and General Parenting Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2021to 22 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- First-year incoming LMU student consented to participate in the study and their parent/guardian created a profile on the app
Who cannot join
- Outside of the students age range
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extension and Online Adaptation of the FITSTART Parent-based Intervention to Reduce Drinking Among First-year Students
FITSTART (Feedback Intervention Targeting Student Transitions and Risk Trajectories) is a parent-based social norms intervention that has been shown to reduce risky drinking in incoming first year students.This program uses normative feedback to correct parents overestimation of other parents negative alcohol-related parenting practices (e.g., number of drinks parents would permit their college student to consume). Theory and research suggests that correcting those common misperceptions can motivate parents to adjust their own behaviors (e.g., reducing the number of drinks they would permit), which, in turn, can impact college student drinking. Despite FITSTARTs success, the design of the program limits participation to only students who have parents who can attend on-campus orientation sessions during the summer months before the start of the Fall semester. To address this limitation and extend the previous work, the proposed randomized clinical trial (RCT) will evaluate the efficacy of an online adaptation of the FITSTART(+) PBI program. To examine the efficacy of the newly developed FITSTART+ PBI web app, the proposed RCT will use a longitudinal design to examine if students self-report drinking and related negative consequences during their first semester in college significantly differed between FITSTART+ PBI (intervention app) and a control version of the app. Self-reported drinking and consequences are expected to be lower amongst students with parents randomized to FITSTART+ PBI relative to those with parents randomized to the control app.
Read the detailed description
Heavy episodic drinking (HED) rates remains at unacceptably high levels on college campuses. Researchers on parent-based interventions (PBIs) has revealed promising results. but studies have generally failed to reduce HED in college students. FITSTART was developed to address two limitations of traditional PBIs that may contribute to the lack of the aforementioned effects: (I) they are purely informational and (II) they typically lack a motivational component to capture parents' attention and increase motivation to proactively engage their students. Pilot work has revealed that parents display predictable normative misperceptions (e.g., overestimate how approving other parents are of drinking and underestimate how often other parents engage with their students about drinking). As predicted by social norms theory, these false beliefs are associated with parents displaying more approving attitudes themselves and communicating less frequently. Correcting these norms should motivate parents to proactively engage their child in risk-reducing directions. FITSTART combined a social norms feedback component with informational material ("tips") characteristic of a traditional PBI in an in-person interactive format and successfully reduced HED. While the effects on weekly drinking, HED, and non-drinker alcohol use initiation were robust 1-month into college (3-months post intervention). FITSTART's usefulness as a universal approach is limited because it was delivered to parent groups on-campus during pre-college orientation sessions and many colleges do not hold summer orientations and/or lack the resources to administer FITSTART. To address this limitation, a web-based platform (or app) was developed using a new cutting-edge modality that draws from the computer science literature on virtual co-presence to create an online environment that mimics the effects of a live group social norms session.
The current pilot study seeks to evaluate the efficacy of the FITSTART+ PBI in a randomized control trial (RCT) by evaluating changes in incoming first-year students' alcohol use and related negative consequences during the transition into college. The sample will consist of traditional first year students (17-20 years of age) from Loyola Marymount University who completed consent and the baseline survey, and whose parents downloaded and registered for the FITSTART+ intervention or control app. Parents will be invited to download the intervention/control app two weeks prior to their student's arrival on campus in the fall (beginning of August). To examine the short- and long-term effects of the intervention, students will complete a baseline survey at the end of July (pre- matriculation) and two follow-up surveys, approximately 1 month (October) and 6 months (April) after the students arrive on campus in the spring.
- Conditions
- Alcohol Drinking, Alcohol Problem Drinking, Parenting
- Being tested
- FITSTART+ PBI, General Parenting Advice
- Keywords
- Parent Intervention, Alcohol Intervention, College Student Drinking
- Medical subject headings
- Alcohol Drinking, Alcoholism, Alcohol Drinking in College
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FITSTART+ PBIBehavioural
Personalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice
General Parenting AdviceBehavioural
General parenting advice
| Study group | Role | What they receive |
|---|---|---|
| Intervention App | Experimental | Students in arm of the study will have a parent who has access to the following content in the parent app: (a) FITSTART+ PBI materials (personalized normative feedback quiz, information on college student drinking, and alcohol-specific advice for parents of first year students); (b) general advice for parents of college students (e.g., improving communication; reducing conflict); (c) information about university resources; and (d) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). Receives: Behavioral: FITSTART+ PBI |
| Control App | Placebo comparator | Students in this arm of the study will have a parent who has access to the following content in the parent app: (a) general advice for parents of college students (e.g., improving communication; reducing conflict); (b) information about university resources; and (c) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). Receives: Behavioral: General Parenting Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Typical Weekly Drinking at 1 Month
At baseline and the 1-month follow-up, participants reported the typical quantity of standard alcohol drinks consumed on each day of the week during the past 30 days using the Daily Drinking Questionnaire. Quantity of drinks reported on each day of the week at baseline and 1-month were then summed (separately) to create a composite variable assessing typical weekly drinking at each time point. To compute the outcome, the 1-month measure of typical drinks per week was subtracted from the baseline measure of typical drinks per week such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Measured: baseline, 1 month
Change From Baseline Typical Weekly Drinking at 6 Months
At baseline and the 6-month follow-up, participants reported the typical quantity of standard alcohol drinks consumed on each day of the week during the past 30 days using the Daily Drinking Questionnaire. Quantity of drinks reported on each day of the week at baseline and 1-month were then summed (separately) to create a composite variable assessing typical weekly drinking at each time point. To compute the outcome, the 6-month measure of typical drinks per week was subtracted from the baseline measure of typical drinks per week such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Measured: baseline, 6 months
Change From Baseline Frequency of Alcohol Consequences at 1 Month
At baseline and the 1-month follow-up, the number of types of negative alcohol-related consequences experienced out of a list of 14 common negative alcohol-related consequences (past 30 days) were summed to create a composite variable at each time point. To compute the outcome, the 1-month measure of negative consequences was subtracted from the baseline measure of negative consequences such that a positive value indicates a decrease in consequences during this period and a negative value indicates an increase in consequences during this period.
Measured: baseline, 1 month
Change From Baseline Frequency of Alcohol Consequences at 6 Months
At baseline and the 6-month follow-up, the number of types of negative alcohol-related consequences experienced out of a list of 14 common negative alcohol-related consequences (past 30 days) were summed to create a composite variable at each time point. To compute the outcome, the 6-month measure of negative consequences was subtracted from the baseline measure of negative consequences such that a positive value indicates a decrease in consequences during this period and a negative value indicates an increase in consequences during this period.
Measured: baseline, 6 months
Change From Baseline Quantity/Frequency/Peak Alcohol Use at 1 Month
At baseline and the 1-month follow-up, an item assessing the number of maximum drinks on one occasion from the Frequency, Quantity, Max (FQM) measure was used to assess peak drinks on one occasion over the past 30 days. To compute the outcome, the 1-month measure of peak drinks was subtracted from the baseline measure of peak drinks such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Measured: baseline, 1 month
Change From Baseline Quantity/Frequency/Peak Alcohol Use at 6 Months
At baseline and the 6-month follow-up, an item assessing the number of maximum drinks on one occasion from the Frequency, Quantity, Max (FQM) measure was used to assess peak drinks on one occasion over the past 30 days. To compute the outcome, the 6-month measure of peak drinks was subtracted from the baseline measure of peak drinks such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Measured: baseline, 6 months
Change From Baseline Heavy Episodic Drinking at 1 Month
At baseline and the 1-month follow-up, an item assessing the number of times students reported a heavy episodic drinking (HED) event in the past two weeks. To compute the outcome, the 1-month measure of HED was subtracted from the baseline measure of HED such that a positive value indicates a decrease in HED events during this period and a negative value indicates an increase in HED events during this period.
Measured: baseline, 1 month
Change From Baseline Heavy Episodic Drinking at 6 Months
At baseline and the 1-month follow-up, an item assessing the number of times students reported a heavy episodic drinking (HED) event in the past two weeks. To compute the outcome, the 1-month measure of HED was subtracted from the baseline measure of HED such that a positive value indicates a decrease in HED events during this period and a negative value indicates an increase in HED events during this period.
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start22 Jul 2021
- Primary completion22 Mar 2022
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol DrinkingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola Marymount University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Dr. Joseph LaBrie, Loyola Marymount University
- Investigators
- Joseph W LaBrie, PhD, Principal investigator, Loyola Marymount University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549454
- Sponsor's protocol ID
- LoyolaMarymountU
- Other IDs
- R34AA026422
- Acronym
- FITSTART+
- Status last verified
- May 2023
- First submitted
- 8 Sep 2020
- Last updated
- 1 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results will be reported in aggregate, so that individual participants will not be identifiable in any research reports or presentations of the proposed study. A de-identified dataset will be made available to researchers 1 year after the initial publication of results. This dataset will include participant demographics and outcome measures assessed at baseline and the follow-up surveys. A data dictionary will be provided.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension and Online Adaptation of the FITSTART Parent-based Intervention to Reduce Drinking Among First-year Students
- ClinicalTrials.gov ID
- NCT04549454
- Acronym / sponsor ID
- FITSTART+ / LoyolaMarymountU
- Conditions
- Alcohol Drinking, Alcohol Problem Drinking, Parenting
- Keywords
- Parent Intervention, Alcohol Intervention, College Student Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Loyola Marymount UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Posted 1 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
FITSTART (Feedback Intervention Targeting Student Transitions and Risk Trajectories) is a parent-based social norms intervention that has been shown to reduce risky drinking in incoming first year students.This program uses normative feedback to correct parents overestimation of other parents negative alcohol-related parenting practices (e.g., number of drinks parents would permit their college student to consume). Theory and research suggests that correcting those common misperceptions can motivate parents to adjust their own behaviors (e.g., reducing the number of drinks they would permit), which, in turn, can impact college student drinking. Despite FITSTARTs success, the design of the program limits participation to only students who have parents who can attend on-campus orientation sessions during the summer months before the start of the Fall semester. To address this limitation and extend the previous work, the proposed randomized clinical trial (RCT) will evaluate the efficacy of an online adaptation of the FITSTART(+) PBI program. To examine the efficacy of the newly developed FITSTART+ PBI web app, the proposed RCT will use a longitudinal design to examine if students self-report drinking and related negative consequences during their first semester in college significantly differed between FITSTART+ PBI (intervention app) and a control version of the app. Self-reported drinking and consequences are expected to be lower amongst students with parents randomized to FITSTART+ PBI relative to those with parents randomized to the control app.
Detailed description
Heavy episodic drinking (HED) rates remains at unacceptably high levels on college campuses. Researchers on parent-based interventions (PBIs) has revealed promising results. but studies have generally failed to reduce HED in college students. FITSTART was developed to address two limitations of traditional PBIs that may contribute to the lack of the aforementioned effects: (I) they are purely informational and (II) they typically lack a motivational component to capture parents' attention and increase motivation to proactively engage their students. Pilot work has revealed that parents display predictable normative misperceptions (e.g., overestimate how approving other parents are of drinking and underestimate how often other parents engage with their students about drinking). As predicted by social norms theory, these false beliefs are associated with parents displaying more approving attitudes themselves and communicating less frequently. Correcting these norms should motivate parents to proactively engage their child in risk-reducing directions. FITSTART combined a social norms feedback component with informational material ("tips") characteristic of a traditional PBI in an in-person interactive format and successfully reduced HED. While the effects on weekly drinking, HED, and non-drinker alcohol use initiation were robust 1-month into college (3-months post intervention). FITSTART's usefulness as a universal approach is limited because it was delivered to parent groups on-campus during pre-college orientation sessions and many colleges do not hold summer orientations and/or lack the resources to administer FITSTART. To address this limitation, a web-based platform (or app) was developed using a new cutting-edge modality that draws from the computer science literature on virtual co-presence to create an online environment that mimics the effects of a live group social norms session.
The current pilot study seeks to evaluate the efficacy of the FITSTART+ PBI in a randomized control trial (RCT) by evaluating changes in incoming first-year students' alcohol use and related negative consequences during the transition into college. The sample will consist of traditional first year students (17-20 years of age) from Loyola Marymount University who completed consent and the baseline survey, and whose parents downloaded and registered for the FITSTART+ intervention or control app. Parents will be invited to download the intervention/control app two weeks prior to their student's arrival on campus in the fall (beginning of August). To examine the short- and long-term effects of the intervention, students will complete a baseline survey at the end of July (pre- matriculation) and two follow-up surveys, approximately 1 month (October) and 6 months (April) after the students arrive on campus in the spring.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention App | Experimental | Behavioral: FITSTART+ PBIStudents in arm of the study will have a parent who has access to the following content in the parent app: (a) FITSTART+ PBI materials (personalized normative feedback quiz, information on college student drinking, and alcohol-specific advice for parents of first year students); (b) general advice for parents of college students (e.g., improving communication; reducing conflict); (c) information about university resources; and (d) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). |
| Control App | Placebo comparator | Behavioral: General Parenting AdviceStudents in this arm of the study will have a parent who has access to the following content in the parent app: (a) general advice for parents of college students (e.g., improving communication; reducing conflict); (b) information about university resources; and (c) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). |
Who may qualify
- Ages
- 17 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- First-year incoming LMU student consented to participate in the study and their parent/guardian created a profile on the app
Key exclusion criteria (1 listed)
- Outside of the students age range
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 |
|---|---|---|
| FITSTART+ PBIPersonalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice | Behavioural | Intervention App |
| General Parenting AdviceGeneral parenting advice | Behavioural | Control App |
Primary outcome
Change From Baseline Typical Weekly Drinking at 1 Month
Time frame: baseline, 1 month
At baseline and the 1-month follow-up, participants reported the typical quantity of standard alcohol drinks consumed on each day of the week during the past 30 days using the Daily Drinking Questionnaire. Quantity of drinks reported on each day of the week at baseline and 1-month were then summed (separately) to create a composite variable assessing typical weekly drinking at each time point. To compute the outcome, the 1-month measure of typical drinks per week was subtracted from the baseline measure of typical drinks per week such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Change From Baseline Typical Weekly Drinking at 6 Months
Time frame: baseline, 6 months
At baseline and the 6-month follow-up, participants reported the typical quantity of standard alcohol drinks consumed on each day of the week during the past 30 days using the Daily Drinking Questionnaire. Quantity of drinks reported on each day of the week at baseline and 1-month were then summed (separately) to create a composite variable assessing typical weekly drinking at each time point. To compute the outcome, the 6-month measure of typical drinks per week was subtracted from the baseline measure of typical drinks per week such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Change From Baseline Frequency of Alcohol Consequences at 1 Month
Time frame: baseline, 1 month
At baseline and the 1-month follow-up, the number of types of negative alcohol-related consequences experienced out of a list of 14 common negative alcohol-related consequences (past 30 days) were summed to create a composite variable at each time point. To compute the outcome, the 1-month measure of negative consequences was subtracted from the baseline measure of negative consequences such that a positive value indicates a decrease in consequences during this period and a negative value indicates an increase in consequences during this period.
Change From Baseline Frequency of Alcohol Consequences at 6 Months
Time frame: baseline, 6 months
At baseline and the 6-month follow-up, the number of types of negative alcohol-related consequences experienced out of a list of 14 common negative alcohol-related consequences (past 30 days) were summed to create a composite variable at each time point. To compute the outcome, the 6-month measure of negative consequences was subtracted from the baseline measure of negative consequences such that a positive value indicates a decrease in consequences during this period and a negative value indicates an increase in consequences during this period.
Change From Baseline Quantity/Frequency/Peak Alcohol Use at 1 Month
Time frame: baseline, 1 month
At baseline and the 1-month follow-up, an item assessing the number of maximum drinks on one occasion from the Frequency, Quantity, Max (FQM) measure was used to assess peak drinks on one occasion over the past 30 days. To compute the outcome, the 1-month measure of peak drinks was subtracted from the baseline measure of peak drinks such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Change From Baseline Quantity/Frequency/Peak Alcohol Use at 6 Months
Time frame: baseline, 6 months
At baseline and the 6-month follow-up, an item assessing the number of maximum drinks on one occasion from the Frequency, Quantity, Max (FQM) measure was used to assess peak drinks on one occasion over the past 30 days. To compute the outcome, the 6-month measure of peak drinks was subtracted from the baseline measure of peak drinks such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Change From Baseline Heavy Episodic Drinking at 1 Month
Time frame: baseline, 1 month
At baseline and the 1-month follow-up, an item assessing the number of times students reported a heavy episodic drinking (HED) event in the past two weeks. To compute the outcome, the 1-month measure of HED was subtracted from the baseline measure of HED such that a positive value indicates a decrease in HED events during this period and a negative value indicates an increase in HED events during this period.
Change From Baseline Heavy Episodic Drinking at 6 Months
Time frame: baseline, 6 months
At baseline and the 1-month follow-up, an item assessing the number of times students reported a heavy episodic drinking (HED) event in the past two weeks. To compute the outcome, the 1-month measure of HED was subtracted from the baseline measure of HED such that a positive value indicates a decrease in HED events during this period and a negative value indicates an increase in HED events during this period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Study results will be reported in aggregate, so that individual participants will not be identifiable in any research reports or presentations of the proposed study. A de-identified dataset will be made available to researchers 1 year after the initial publication of results. This dataset will include participant demographics and outcome measures assessed at baseline and the follow-up surveys. A data dictionary will be provided.
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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.
Joseph W LaBrie, PhD principal investigator
Loyola Marymount University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FITSTART+ PBI and General Parenting Advice in people with Alcohol Drinking and Alcohol Problem Drinking, run by Loyola Marymount University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Jun 2023. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 1 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Typical Weekly Drinking at 1 Month (time frame: baseline, 1 month). The study lists 8 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 1 Jun 2023.