Drinking; Excess, Habit (Continual)NCT03889873
Evaluating Change in Drinking Identity as a Mechanism for Reducing Hazardous Drinking - Study 2
A study testing Narrative Writing in people with Drinking; Excess, Habit (Continual) and Identity, Social, run by University of Washington at 1 site in United States.
Trial summary
The purpose of the proposed research is to evaluate whether changes in drinking identity (DI; how much one associates one's self with drinking) can reduce hazardous drinking (HD; heavy alcohol use and negative alcohol-related consequences) among current college students. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Drinking; Excess, Habit (Continual), Identity, Social
- What is being tested?
- Narrative Writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 329 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2019to 7 Jun 2021
- Phase
- Interventional
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be full-time UW students, fluent in the English language, and recent (past week) drinkers who self-report drinking hazardously (i.e., score an 8 or above on the Alcohol Use Disorder Identification Test, AUDIT). Participants must also own a smartphone.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the proposed research is to evaluate whether changes in drinking identity (DI; how much one associates one's self with drinking) can reduce hazardous drinking (HD; heavy alcohol use and negative alcohol-related consequences) among current college students. The study seeks to explore whether manipulating DI among participants will have changes in self-efficacy, craving, and HD. If such an effect can be found, DI may be a mechanism for HD behavior change and will allow researchers to develop and improve interventions aimed at HD behaviors in high-risk young adults.
Read the detailed description
Experimentally manipulate DI to increase self-efficacy, decrease alcohol craving and reduce HD. We will recruit 328 student hazardous drinkers and use an expressive writing task to manipulate their DI, the salience of their social network, and their writing perspective. The last factor is included because writing in a self-distanced (3rd person) vs. self-immersed (1st person) perspective has been linked to greater cognitive control. We will evaluate the manipulation's immediate effects on DI, self-efficacy, and craving. Participants will also complete two weekly follow-up "booster" sessions. Longer-term effects on DI, self-efficacy, craving and HD will be evaluated at additional 2-week, 1-month, and 3-month follow-ups.
With the outbreak of the COVID-19 pandemic, new subject enrollment was paused between March and September 2020. In light of the continued COVID-19 pandemic, the study team made the decision to move the in-person, lab-based session (where participants completed the writing task) to online sessions as of October 2020. With the move to online sessions, we have discontinued the cue reactivity task and the accompanying craving assessment. Inclusion criteria have shifted slightly -- we now explicitly require participants to be currently living in Washington State (this criterion was implicit in our previous criteria and procedures) . The structure of the study otherwise remains the same.
- Being tested
- Narrative Writing
- Keywords
- Drinking identity, Hazardous drinking, Social networks, Self-efficacy, Alcohol craving, Cognitive control, Narrative writing
- Medical subject headings
- Habits, Social Identification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative WritingBehavioural
An writing task in which participants are given a description of a possible future self (that varies 3 factors: topic; drinking vs. smartphone; perspective: 1st vs. 3rd-person; and social network: specifically asked to be included vs. not specifically asked to be included). Participants are asked to imagine that future self vividly and to write about the thoughts and feeling describe themselves and their experiences, the characteristics they hope or wish they will ideally possess, the characteristics that they would need to have and the roles they will take on or things they will be doing. Participants are given 20 minutes to think and write. They will write and think about the same future on each of three lab-sessions (which occur at 1-week intervals).
| Study group | Role | What they receive |
|---|---|---|
| Drinking; No network; First-person | Experimental | In this narrative writing task, the participant is asked to imagine him/herself as a low-risk drinker and describe this future self; the prompt does not instruct to write about social network (important people, friends, family); participant will write using first-person pronouns. Receives: Behavioral: Narrative Writing |
| Drinking; Network; First-person | Experimental | In this narrative writing task, the participant is asked to imagine him/herself as a low-risk drinker and describe this future self; the prompt instructions include writing about social network (important people, friends, family); participant will write using first-person pronouns. Receives: Behavioral: Narrative Writing |
| Drinking; No network; Third-person | Experimental | In this narrative writing task, the participant is asked to imagine him/herself as a low-risk drinker and describe this future self; the prompt does not instruct to write about social network (important people, friends, family); participant will write using third-person pronouns. Receives: Behavioral: Narrative Writing |
| Drinking; Network; Third-person | Experimental | In this narrative writing task, the participant is asked to imagine him/herself as a low-risk drinker and describe this future self; the prompt instructions include writing about social network (important people, friends, family); participant will write using third-person pronouns. Receives: Behavioral: Narrative Writing |
| Smartphone; No network; First-person | Experimental | In this narrative writing task, the participant is asked to imagine him/herself as someone who has reduced their smartphone usage and describe this future self; the prompt does not instruct to write about social network (important people, friends, family); participant will write using first-person pronouns. Receives: Behavioral: Narrative Writing |
| Smartphone; Network; First-person | Experimental | In this narrative writing task, the participant is asked to imagine him/herself as someone who has reduced their smartphone usage and describe this future self; the prompt instructions include writing about social network (important people, friends, family); participant will write using first-person pronouns. Receives: Behavioral: Narrative Writing |
| Smartphone; No network; Third-person | Experimental | In this narrative writing task, the participant is asked to imagine him/herself as someone who has reduced their smartphone usage and describe this future self; the prompt does not instruct to write about social network (important people, friends, family); participant will write using third-person pronouns. Receives: Behavioral: Narrative Writing |
| Smartphone; Network; Third-person | Experimental | In this narrative writing task, the participant is asked to imagine him/herself as someone who has reduced their smartphone usage and describe this future self; the prompt instructions include writing about social network (important people, friends, family); participant will write using third-person pronouns. Receives: Behavioral: Narrative Writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Implicit Drinking identity
drinking identity implicit association test (IAT)
Measured: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
Changes in Explicit Drinking identity
Alcohol Self-concept Scale; item responses range from -3 to +3; average score on all items is calculated; lower scores represent a better outcome
Measured: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
changes in self-efficacy
drinking refusal self-efficacy questionnaire
Measured: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
cue-related craving
current craving from cue reactivity task; assessed via alcohol urge questionnaire
Measured: Cue related craving will be assessed following the cue reactivity task, which occurs during the third and final lab-based session (technically, the third week of the study)
changes in past week craving
Penn Alcohol Craving Scale; item responses range from 0 to 6; total score on all items is calculated (can range from 0 to 30); lower scores = better outcome
Measured: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
changes in alcohol consumption
Modified timeline follow back will assess past daily alcohol consumption (# standard drinks per day); higher consumption = worse outcomes
Measured: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
changes in last 3 month alcohol problems
Rutgers Alcohol Problems Inventory (RAPI) will be used to assess alcohol problems; item response options range from 0 to 4; total score ranges from 0 to 100; higher scores = worse outcomes
Measured: Assessed at lab 1 (week1) and 3-month follow up; data will be reported through study completion (3 month follow up)
changes in last two week alcohol problems
adapted from RAPI \& Young Adult Alcohol Problems Screening Test (YAAPST); item responses are 0 (did not happen) or 1 (happened); higher scores (range from 0 to 10) = worse outcomes
Measured: assessed at lab 2 and 3 (weeks 2 and 3) and at 2 week and 1 month follow up; data will be reported through 1 month follow up
Secondary outcomes (4)
changes in future drinking intentions
adapted from daily drinking questionnaire; assesses how much individuals think they will drink each day of the next week
Measured: assessed at lab 1, lab 2, lab 3 (weeks 1-3); data will be reported through week 3
changes in frequency of heavy & extreme binge drinking
frequency of heavy episodic (4/5 or more drinks for women/men on a single occasion) and extreme binge drinking (at least 8/10 drinks or at least 12/15 drinks for women/men on a single occasion); definitions are from the National Institute of Alcohol and Alcoholism
Measured: assessed at lab 1 (week 1) &
Changes in Readiness to Change Drinking
single item about readiness to change one's drinking (from Rollnick, Mason, \& Butler, 1999); ranges from 0 to 6; higher scores = more readiness to change one's drinking; higher scores = better outcome
Measured: post-writing (lab 1, lab 2, lab 3) long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
Changes in single-item assessing self-efficacy to limit one's drinking
Item developed by Cervone \& Shadel; item ranges from 0 to10; higher scores = greater self-efficacy to limit one's drinking; higher scores = better outcome
Measured: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start18 Apr 2019
- Primary completion26 Feb 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drinking; Excess, Habit (Continual)Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Participants are randomly assigned to a condition to receive one of eight writing prompt variants in a 2x2x2 study design. There is also a within subjects component as participants complete the same writing prompt 3 times (once per week over a 3-week period).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Kristen Lindgren, University of Washington
- Investigators
- Kristen P Lindgren, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889873
- Sponsor's protocol ID
- STUDY00006542
- Other IDs
- 1R01AA024732-01
- Status last verified
- Sep 2021
- First submitted
- 14 Mar 2019
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share responses to questionnaires and writing exercises with co-investigators. We do not currently have plans to store data in a repository/database (for example, via the Open Science Framework \[OSF\] - https://osf.io/), though we may ultimately do so should this be a condition of publishing in a scientific journal or necessary for other unforeseen reasons. Should we do so, we would not publish or make available or the narrative writing responses verbatim. Similarly, we would also not publish or make available the variables that describe the 10 most important people on the important people measure. No direct identifiers will be included in any data shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Change in Drinking Identity as a Mechanism for Reducing Hazardous Drinking - Study 2
- ClinicalTrials.gov ID
- NCT03889873
- Acronym / sponsor ID
- STUDY00006542
- Keywords
- Drinking identity, Hazardous drinking, Social networks, Self-efficacy, Alcohol craving, Cognitive control, Narrative writing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the proposed research is to evaluate whether changes in drinking identity (DI; how much one associates one's self with drinking) can reduce hazardous drinking (HD; heavy alcohol use and negative alcohol-related consequences) among current college students. The study seeks to explore whether manipulating DI among participants will have changes in self-efficacy, craving, and HD. If such an effect can be found, DI may be a mechanism for HD behavior change and will allow researchers to develop and improve interventions aimed at HD behaviors in high-risk young adults.
Detailed description
Experimentally manipulate DI to increase self-efficacy, decrease alcohol craving and reduce HD. We will recruit 328 student hazardous drinkers and use an expressive writing task to manipulate their DI, the salience of their social network, and their writing perspective. The last factor is included because writing in a self-distanced (3rd person) vs. self-immersed (1st person) perspective has been linked to greater cognitive control. We will evaluate the manipulation's immediate effects on DI, self-efficacy, and craving. Participants will also complete two weekly follow-up "booster" sessions. Longer-term effects on DI, self-efficacy, craving and HD will be evaluated at additional 2-week, 1-month, and 3-month follow-ups.
With the outbreak of the COVID-19 pandemic, new subject enrollment was paused between March and September 2020. In light of the continued COVID-19 pandemic, the study team made the decision to move the in-person, lab-based session (where participants completed the writing task) to online sessions as of October 2020. With the move to online sessions, we have discontinued the cue reactivity task and the accompanying craving assessment. Inclusion criteria have shifted slightly -- we now explicitly require participants to be currently living in Washington State (this criterion was implicit in our previous criteria and procedures) . The structure of the study otherwise remains the same.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 8
- Model description
- Participants are randomly assigned to a condition to receive one of eight writing prompt variants in a 2x2x2 study design. There is also a within subjects component as participants complete the same writing prompt 3 times (once per week over a 3-week period).
| Arm | Type | Receives |
|---|---|---|
| Drinking; No network; First-person | Experimental | Behavioral: Narrative WritingIn this narrative writing task, the participant is asked to imagine him/herself as a low-risk drinker and describe this future self; the prompt does not instruct to write about social network (important people, friends, family); participant will write using first-person pronouns. |
| Drinking; Network; First-person | Experimental | Behavioral: Narrative WritingIn this narrative writing task, the participant is asked to imagine him/herself as a low-risk drinker and describe this future self; the prompt instructions include writing about social network (important people, friends, family); participant will write using first-person pronouns. |
| Drinking; No network; Third-person | Experimental | Behavioral: Narrative WritingIn this narrative writing task, the participant is asked to imagine him/herself as a low-risk drinker and describe this future self; the prompt does not instruct to write about social network (important people, friends, family); participant will write using third-person pronouns. |
| Drinking; Network; Third-person | Experimental | Behavioral: Narrative WritingIn this narrative writing task, the participant is asked to imagine him/herself as a low-risk drinker and describe this future self; the prompt instructions include writing about social network (important people, friends, family); participant will write using third-person pronouns. |
| Smartphone; No network; First-person | Experimental | Behavioral: Narrative WritingIn this narrative writing task, the participant is asked to imagine him/herself as someone who has reduced their smartphone usage and describe this future self; the prompt does not instruct to write about social network (important people, friends, family); participant will write using first-person pronouns. |
| Smartphone; Network; First-person | Experimental | Behavioral: Narrative WritingIn this narrative writing task, the participant is asked to imagine him/herself as someone who has reduced their smartphone usage and describe this future self; the prompt instructions include writing about social network (important people, friends, family); participant will write using first-person pronouns. |
| Smartphone; No network; Third-person | Experimental | Behavioral: Narrative WritingIn this narrative writing task, the participant is asked to imagine him/herself as someone who has reduced their smartphone usage and describe this future self; the prompt does not instruct to write about social network (important people, friends, family); participant will write using third-person pronouns. |
| Smartphone; Network; Third-person | Experimental | Behavioral: Narrative WritingIn this narrative writing task, the participant is asked to imagine him/herself as someone who has reduced their smartphone usage and describe this future self; the prompt instructions include writing about social network (important people, friends, family); participant will write using third-person pronouns. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants must be full-time UW students, fluent in the English language, and recent (past week) drinkers who self-report drinking hazardously (i.e., score an 8 or above on the Alcohol Use Disorder Identification Test, AUDIT). Participants must also own a smartphone.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Narrative WritingAn writing task in which participants are given a description of a possible future self (that varies 3 factors: topic; drinking vs. smartphone; perspective: 1st vs. 3rd-person; and social network: specifically asked to be included vs. not specifically asked to be included). Participants are asked to imagine that future self vividly and to write about the thoughts and feeling describe themselves and their experiences, the characteristics they hope or wish they will ideally possess, the characteristics that they would need to have and the roles they will take on or things they will be doing. Participants are given 20 minutes to think and write. They will write and think about the same future on each of three lab-sessions (which occur at 1-week intervals). | Behavioural | Drinking; Network; First-person, Drinking; Network; Third-person, Drinking; No network; First-person, Drinking; No network; Third-person, Smartphone; Network; First-person, Smartphone; Network; Third-person, Smartphone; No network; First-person, Smartphone; No network; Third-person |
Primary outcome
Changes in Implicit Drinking identity
Time frame: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
drinking identity implicit association test (IAT)
Changes in Explicit Drinking identity
Time frame: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
Alcohol Self-concept Scale; item responses range from -3 to +3; average score on all items is calculated; lower scores represent a better outcome
changes in self-efficacy
Time frame: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
drinking refusal self-efficacy questionnaire
cue-related craving
Time frame: Cue related craving will be assessed following the cue reactivity task, which occurs during the third and final lab-based session (technically, the third week of the study)
current craving from cue reactivity task; assessed via alcohol urge questionnaire
changes in past week craving
Time frame: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
Penn Alcohol Craving Scale; item responses range from 0 to 6; total score on all items is calculated (can range from 0 to 30); lower scores = better outcome
changes in alcohol consumption
Time frame: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
Modified timeline follow back will assess past daily alcohol consumption (# standard drinks per day); higher consumption = worse outcomes
changes in last 3 month alcohol problems
Time frame: Assessed at lab 1 (week1) and 3-month follow up; data will be reported through study completion (3 month follow up)
Rutgers Alcohol Problems Inventory (RAPI) will be used to assess alcohol problems; item response options range from 0 to 4; total score ranges from 0 to 100; higher scores = worse outcomes
changes in last two week alcohol problems
Time frame: assessed at lab 2 and 3 (weeks 2 and 3) and at 2 week and 1 month follow up; data will be reported through 1 month follow up
adapted from RAPI \& Young Adult Alcohol Problems Screening Test (YAAPST); item responses are 0 (did not happen) or 1 (happened); higher scores (range from 0 to 10) = worse outcomes
4 secondary outcomes
changes in future drinking intentions
Time frame: assessed at lab 1, lab 2, lab 3 (weeks 1-3); data will be reported through week 3
changes in frequency of heavy & extreme binge drinking
Time frame: assessed at lab 1 (week 1) &
Changes in Readiness to Change Drinking
Time frame: post-writing (lab 1, lab 2, lab 3) long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
Changes in single-item assessing self-efficacy to limit one's drinking
Time frame: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: Yes. We will share responses to questionnaires and writing exercises with co-investigators. We do not currently have plans to store data in a repository/database (for example, via the Open Science Framework [OSF] - https://osf.io/), though we may ultimately do so should this be a condition of publishing in a scientific journal or necessary for other unforeseen reasons. Should we do so, we would not publish or make available or the narrative writing responses verbatim. Similarly, we would also not publish or make available the variables that describe the 10 most important people on the important people measure. No direct identifiers will be included in any data shared.
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.
Kristen P Lindgren, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Writing in people with Drinking; Excess, Habit (Continual) and Identity, Social, run by University of Washington 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 4 Oct 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Implicit Drinking identity (time frame: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)). 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 4 Oct 2021; AzTrials last refreshed its copy on 29 Oct 2026.