VapingPhase 4PilotNCT04602494

Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents

A Phase 4 study testing Varenicline in people with Vaping and Nicotine Dependence, run by Massachusetts General Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 25 years
Conditions the study is for: Vaping, Nicotine Dependence
What is being tested?: Varenicline
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 18 Dec 2020to 27 Jun 2022
Phase: Phase 4
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 18 to 25 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Ages 18-25 inclusive;
Self report of daily or near daily nicotine vaping for the prior ≥ 3 months, screening semi-quantitative urine cotinine positive for recent nicotine use, exhaled CO <10 ppm and score ≥4 on the 10-item E-cigarette Dependence Inventory (ECDI);
Self-report of no combusted tobacco use in the past 2 months at enrollment;
Total body weight at screening ≥35 kg (77 lbs) and Body Mass Index (BMI) ≤35 kg/m2;
Report motivation to quit vaping in the next 30 days;
Able to understand study procedures and read and write in English;
Competent and willing to consent to participate in study procedures.

Who cannot join

Use of a smoking cessation medication in the prior month (nicotine patch, gum, nasal spray, or inhaler, varenicline, bupropion);
Unwillingness to abstain during the study from using smoking cessation aids other than those provided by the study;
Unstable medical condition, epilepsy, severe renal impairment;
Evidence of active problem substance use severe enough in the investigator's opinion to compromise ability to safely participate;
Prior adverse drug reaction to varenicline;
Unwilling to provide urine samples;
Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Addiction Medicine
Boston, Massachusetts, 02114

Other trials in United States

About this study

The Investigators propose a randomized, placebo-controlled trial to test the hypothesis that varenicline added to group behavioral and texting support will be well tolerated and improve vaping cessation rates among nicotine dependent adolescents who vape, do not smoke regularly, and are willing to try treatment to stop vaping compared to placebo added to group behavioral and texting support. The study will consist of a three-arm randomized, placebo-controlled, parallel-group study of (1) varenicline up to 1 mg bid for 12 weeks added to behavioral and texting support compared with (2) behavioral and texting support and placebo and (3) monitoring only. The primary comparison will be of vaping cessation rates in those assigned to varenicline vs placebo.To do this, the investigators propose to enroll 300 adolescents aged 16-25 who meet eligibility criteria.

Read the detailed description

Enrollees will include 300 nicotine dependent adolescents aged 16-25, who vape, do not smoke, and want to quit vaping. The study will will consist of a three-arm randomized, placebo-controlled, parallel-group study of (1) varenicline up to 1 mg bid for 12 weeks added to behavioral and texting support for adolescent vaping cessation or (2) behavioral and texting support and placebo or (3) monitoring only. The primary comparison of interest is efficacy of (1) varenicline vs (2) placebo arms on vaping abstinence outcomes. The study consists of one enrollment visit, one baseline visit, twelve weekly individual treatment and assessment sessions, and six monthly visits at weeks 4, 8, 12, 16, 20 and 24 weeks. At the enrollment visit, participants will complete interviews, questionnaires and diagnostic assessments, as well as saliva and urine sample and vitals. At the baseline visit, participants will complete several interviews, questionnaires, provide a saliva sample for cotinine measurement, and be randomized to the varenicline plus behavioral treatment group, the placebo plus behavioral treatment group, or monitoring-only group. Study staff will distribute varenicline or identically appearing placebo with instructions on how to take the study medication at weeks 0, 2, 4 and 8. Participants will be instructed to bring all empty and unused study medication at each in-person study visit through Week 12. At the weekly treatment meetings, participants will participate in cognitive behavioral therapy and complete questionnaires. Monthly visits will consist of interviews, questionnaires and a saliva and urine sample.

Conditions: Vaping, Nicotine Dependence
Being tested: Varenicline, Placebo
Keywords: Vaping, Nicotine, Adolescents, Cessation, Varenicline
Medical subject headings: Vaping, Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VareniclineDrug
Also called Chantix
varenicline: 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7 and starting on day 8, 1 mg twice daily for a total of 12 weeks
PlaceboDrug
Identical placebo: 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7 and starting on day 8, 1 mg twice daily for a total of 12 weeks

Study groups in NCT04602494
Study group	Role	What they receive
Varenicline	Experimental	Participants will receive varenicline 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7 and starting on day 8, 1 mg twice daily for a total of 12 weeks added to 12 weeks of group behavioral and texting support specifically designed for teen vaping cessation Receives: Drug: Varenicline
Placebo	Placebo comparator	Participants will receive identical placebo 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7 and starting on day 8, 1 mg twice daily for a total of 12 weeks added to 12 weeks of group behavioral and texting support specifically designed for teen vaping cessation Receives: Drug: Placebo
Monitoring only	No intervention	Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Continuous Nicotine Vaping Abstinence From Week 9 Through End of Treatment (Week 12)
Those assigned to varenicline and group behavioral and texting support will have a higher rate of cotinine verified, continuous nicotine vaping abstinence from study week 9 to end of treatment as operationalized by self-report of no nicotine vaping since the last study visit on a timeline followback assessment and urinary cotinine <50 ng/mL at each study visit in the designated timeframe.
Measured: Weeks 9-12
Percentage of Participants With Continuous Nicotine Vaping Abstinence From Week 9 Through End of Follow-up (Week 24)
Those assigned to varenicline and group behavioral and texting support will have a higher rate of cotinine verified, continuous nicotine vaping abstinence from study week 9 to end of follow-up as operationalized by self-report of no nicotine vaping since the last study visit on a timeline followback assessment and urinary cotinine <50 ng/ml at each study visit in the designated timeframe.
Measured: Weeks 9-24
Percentage of Change in Nicotine Product Exposure
Those assigned to varenicline will have greater percentage reduction in vaped nicotine product exposure than those assigned to placebo as determined by urine cotinine from baseline to week 24. Cotinine is a byproduct of nicotine that is used to measure exposure to nicotine product exposure. Positive values represent increases and negative values represent decreases.
Measured: Baseline-week 24
Onset of Vaping Abstinence in Weeks
Those assigned to varenicline will have earlier onset of abstinence. Onset of vaping abstinence (weeks) was assessed by participant self-report of vaping abstinence, and verified by urine cotinine testing.
Measured: Baseline-24 weeks
Latency to First Lapse in Weeks
Those assigned to varenicline will have longer latency to first lapse. This outcome was assessed via self-report and verified by urine cotinine testing.
Measured: Baseline-24 weeks
Latency to Relapse in Weeks
Those assigned to varenicline will have longer latency to relapse. This outcome was assessed by self-report and verified by urine cotinine testing at each study visit.
Measured: Baseline-24 weeks
Duration of Vaping Abstinence in Weeks
Those assigned to varenicline will have a longer duration of abstinence in weeks. This measure was assessed by self-report and verified by urine cotinine testing at each study visit.
Measured: Baseline-24 weeks
Total Number of Days of Vaping Abstinence
Those assigned to varenicline will have greater total number of days of vaping abstinence. Total number of days of vaping abstinence was assessed by self-report and verified by urine cotinine testing at each study visit.
Measured: Baseline-24 weeks

Secondary outcomes (5)

Number of Adverse Events During the Treatment Period
Adverse events are assessed via standardized questions prompting participants to report any changes in their physical or mental health.
Measured: Baseline-week 12
Nicotine Withdrawal Symptoms: Mean Difference (Week 16 - Baseline)
Symptoms will be assessed using the Minnesota Withdrawal Scale (MNWS), a 9-item self-rated scale of nicotine withdrawal symptoms, with scores ranging from 0 - 36, where higher scores indicate a greater degree of withdrawal. The difference between baseline and Week 16 will be computed for each participant.
Measured: Baseline to Week 16
Intensity of Nicotine Craving: Mean Difference (Week 12 - Baseline)
A Visual Analogue Scale was used to measure intensity of nicotine craving. The scale ranged from 0 (no desire at all) to 7 (unable to resist). Higher scores represent more intense nicotine craving.
Measured: Baseline to week 12
Severity of Nicotine Craving: Mean Difference (Week 12 - Baseline)
Severity of nicotine cravings will be assessed using the Questionnaire of Vaping Craving (QVC), a 10-item measure of vaping craving, with scores ranging from 10 - 70, where higher scores indicate greater craving for vaping products. The difference between baseline and Week 12 will be computed for each participant.
Measured: Baseline to Week12
Severity of Clinical Symptoms (Mood and Anxiety): Mean Difference (Week 16 - Baseline)
Severity of clinical symptoms will be assessed by the Mood and Anxiety Symptoms Questionnaire (MASQ-D30), a 30-item measure ranging from 30 - 150, with higher scores indicating a greater degree of clinical distress. The difference between baseline and Week 16 will be computed for each participant.
Measured: Baseline-week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 202027 Jun 2022

First posted26 Oct 2020
Study start18 Dec 2020
Primary completion27 Jun 2022
Study completion27 Jun 2022

Why it stopped: The pilot study used apo-varenicline under temp FDA authorization. When varenicline was available an IND exemption was granted to enroll children, IRB approved a trial of varenicline in participants ages 16-25 June 27, 2022, the pilot was terminated

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 VapingStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This a 3-arm, randomized, placebo-controlled, parallel-group design of (1) varenicline up to 1 mg bid for 12 weeks added to behavioral and texting support vaping cessation compared or (2) behavioral and texting support and placebo or (3) monitoring only.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04602494
Sponsor's protocol ID: 2020P002774-Pilot
Other IDs: R01DA052583
Acronym: Pilot
Status last verified: Apr 2024
First submitted: 20 Oct 2020
Last updated: 4 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices), and the study protocol, statistical analysis plan, analytic code, and informed consent form will be made available to researchers who provide a methodologically sound proposal beginning 3 months and ending 5 years following article publication to achieve aims in the approved proposal. Proposals should be directed to rschuster@mgh.harvard.edu. To gain access, data requestors will need to sign a data access agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Mindful Breaths: Mindfulness for Young Adult Vaping
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Recruiting
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All Vaping trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents
ClinicalTrials.gov ID: NCT04602494
Acronym / sponsor ID: Pilot / 2020P002774-Pilot
Conditions: Vaping, Nicotine Dependence
Keywords: Vaping, Nicotine, Adolescents, Cessation, Varenicline
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The pilot study used apo-varenicline under temp FDA authorization. When varenicline was available an IND exemption was granted to enroll children, IRB approved a trial of varenicline in participants ages 16-25 June 27, 2022, the pilot was terminated
Enrolment: 5 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 18 Dec 2020 (actual)
Primary completion: 27 Jun 2022 (actual)
Study completion: 27 Jun 2022 (actual)
First posted: 26 Oct 2020 (actual)
Results: Posted 4 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3
Model description: This a 3-arm, randomized, placebo-controlled, parallel-group design of (1) varenicline up to 1 mg bid for 12 weeks added to behavioral and texting support vaping cessation compared or (2) behavioral and texting support and placebo or (3) monitoring only.

Arm	Type	Receives
Varenicline	Experimental	Drug: VareniclineParticipants will receive varenicline 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7 and starting on day 8, 1 mg twice daily for a total of 12 weeks added to 12 weeks of group behavioral and texting support specifically designed for teen vaping cessation
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive identical placebo 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7 and starting on day 8, 1 mg twice daily for a total of 12 weeks added to 12 weeks of group behavioral and texting support specifically designed for teen vaping cessation
Monitoring only	No intervention	–Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.

Who may qualify

Ages: 18 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Ages 18-25 inclusive;
Self report of daily or near daily nicotine vaping for the prior ≥ 3 months, screening semi-quantitative urine cotinine positive for recent nicotine use, exhaled CO <10 ppm and score ≥4 on the 10-item E-cigarette Dependence Inventory (ECDI);
Self-report of no combusted tobacco use in the past 2 months at enrollment;
Total body weight at screening ≥35 kg (77 lbs) and Body Mass Index (BMI) ≤35 kg/m2;
Report motivation to quit vaping in the next 30 days;

Key exclusion criteria (7 listed)

Use of a smoking cessation medication in the prior month (nicotine patch, gum, nasal spray, or inhaler, varenicline, bupropion);
Unwillingness to abstain during the study from using smoking cessation aids other than those provided by the study;
Unstable medical condition, epilepsy, severe renal impairment;
Evidence of active problem substance use severe enough in the investigator's opinion to compromise ability to safely participate;
Prior adverse drug reaction to varenicline;

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
VareniclineAlso: Chantixvarenicline: 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7 and starting on day 8, 1 mg twice daily for a total of 12 weeks	Drug	Varenicline
PlaceboIdentical placebo: 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7 and starting on day 8, 1 mg twice daily for a total of 12 weeks	Drug	Placebo

Primary outcome

Percentage of Participants With Continuous Nicotine Vaping Abstinence From Week 9 Through End of Treatment (Week 12)
Time frame: Weeks 9-12
Those assigned to varenicline and group behavioral and texting support will have a higher rate of cotinine verified, continuous nicotine vaping abstinence from study week 9 to end of treatment as operationalized by self-report of no nicotine vaping since the last study visit on a timeline followback assessment and urinary cotinine <50 ng/mL at each study visit in the designated timeframe.
Percentage of Participants With Continuous Nicotine Vaping Abstinence From Week 9 Through End of Follow-up (Week 24)
Time frame: Weeks 9-24
Those assigned to varenicline and group behavioral and texting support will have a higher rate of cotinine verified, continuous nicotine vaping abstinence from study week 9 to end of follow-up as operationalized by self-report of no nicotine vaping since the last study visit on a timeline followback assessment and urinary cotinine <50 ng/ml at each study visit in the designated timeframe.
Percentage of Change in Nicotine Product Exposure
Time frame: Baseline-week 24
Those assigned to varenicline will have greater percentage reduction in vaped nicotine product exposure than those assigned to placebo as determined by urine cotinine from baseline to week 24. Cotinine is a byproduct of nicotine that is used to measure exposure to nicotine product exposure. Positive values represent increases and negative values represent decreases.
Onset of Vaping Abstinence in Weeks
Time frame: Baseline-24 weeks
Those assigned to varenicline will have earlier onset of abstinence. Onset of vaping abstinence (weeks) was assessed by participant self-report of vaping abstinence, and verified by urine cotinine testing.
Latency to First Lapse in Weeks
Time frame: Baseline-24 weeks
Those assigned to varenicline will have longer latency to first lapse. This outcome was assessed via self-report and verified by urine cotinine testing.
Latency to Relapse in Weeks
Time frame: Baseline-24 weeks
Those assigned to varenicline will have longer latency to relapse. This outcome was assessed by self-report and verified by urine cotinine testing at each study visit.
Duration of Vaping Abstinence in Weeks
Time frame: Baseline-24 weeks
Those assigned to varenicline will have a longer duration of abstinence in weeks. This measure was assessed by self-report and verified by urine cotinine testing at each study visit.
Total Number of Days of Vaping Abstinence
Time frame: Baseline-24 weeks
Those assigned to varenicline will have greater total number of days of vaping abstinence. Total number of days of vaping abstinence was assessed by self-report and verified by urine cotinine testing at each study visit.

5 secondary outcomes

Number of Adverse Events During the Treatment Period
Time frame: Baseline-week 12
Nicotine Withdrawal Symptoms: Mean Difference (Week 16 - Baseline)
Time frame: Baseline to Week 16
Intensity of Nicotine Craving: Mean Difference (Week 12 - Baseline)
Time frame: Baseline to week 12
Severity of Nicotine Craving: Mean Difference (Week 12 - Baseline)
Time frame: Baseline to Week12
Severity of Clinical Symptoms (Mood and Anxiety): Mean Difference (Week 16 - Baseline)
Time frame: Baseline-week 16

Results and safety

Results posted to the registry on 4 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Varenicline	1	1
Placebo	1	1
Monitoring Only	2	0

Primary outcome: Percentage of Participants With Continuous Nicotine Vaping Abstinence From Week 9 Through End of Treatment (Week 12)

Time frame: Weeks 9-12. Count of participants. Unit: Participants

Measure	Varenicline n = 1	Placebo n = 1	Monitoring Only n = 2
Value	0	1	0

Population analysed: 5 people enrolled in the pilot, 1 was a screen fail, 4 were enrolled and have been included in the analysis. Due to the small number of participants enrolled in the pilot, data is presented as participant count.

Primary outcome: Percentage of Participants With Continuous Nicotine Vaping Abstinence From Week 9 Through End of Follow-up (Week 24)

Time frame: Weeks 9-24

Population analysed: No participant reached 24 weeks in the study, and as such, were not included in the analysis.

Primary outcome: Percentage of Change in Nicotine Product Exposure

Time frame: Baseline-week 24. Number. Unit: percentage change in nicotine exposure

Measure	Varenicline n = 1	Placebo n = 1	Monitoring Only n = 2
Value	-99	-100	0

Primary outcome: Onset of Vaping Abstinence in Weeks

Time frame: Baseline-24 weeks. Number. Unit: Weeks

Measure	Varenicline n = 1	Placebo n = 1	Monitoring Only n = 0
Value	8	2	–

Population analysed: No participants in the monitoring only group quit vaping.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected over 24 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Varenicline	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Placebo	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Monitoring Only	2 of 2 (100%)	2 of 2 (100%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices), and the study protocol, statistical analysis plan, analytic code, and informed consent form will be made available to researchers who provide a methodologically sound proposal beginning 3 months and ending 5 years following article publication to achieve aims in the approved proposal. Proposals should be directed to rschuster@mgh.harvard.edu. To gain access, data requestors will need to sign a data access agreement.

Related trials for Vaping

Not yet recruitingPhase 1
PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis
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Active, not recruiting
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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.

Eden Evins, MD principal investigator

Massachusetts General Hospital

Randi Schuster, PhD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Varenicline in people with Vaping and Nicotine Dependence, run by Massachusetts General Hospital 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 7 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: stopped early, as of the sponsor's last update on 4 Apr 2024. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2024). 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?

Percentage of Participants With Continuous Nicotine Vaping Abstinence From Week 9 Through End of Treatment (Week 12) (time frame: Weeks 9-12). 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?

On the ClinicalTrials.gov record for NCT04602494.

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 Apr 2024.