Electronic Cigarette UseNCT05971823

Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)

A study testing Tobacco product administration and assessment in people with Electronic Cigarette Use, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine if abuse liability indices will be impacted by varying flavors and e-cigarette (ECIG) nicotine delivery capability (i.e., nicotine flux) among current combustible cigarette users. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Electronic Cigarette Use
What is being tested?: Tobacco product administration and assessment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 31 Jul 2023to 26 Jul 2024
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

healthy (determined by self-report)
at least 18 years old
willing to provide informed consent
able to attend the lab and use designated products according to the study protocol
smoke cigarettes at least 3 days per week, and on those days, at least one cigarette is smoked per day
positive urine cotinine test

Who cannot join

Women who are breastfeeding or test positive for pregnancy (by urinalysis) at screening.
Individuals with the following self-reported current, diagnosed medical condition(s) will be excluded automatically: uncontrolled high blood pressure (via self-report or observed at screening; BP must be less than 160/100), heart-related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g., HIV/AIDS, multiple sclerosis), respiratory disorders (e.g., COPD, asthma), kidney diseases, liver diseases (e.g., cirrhosis), or seizures.
Individuals with other self-reported current, diagnosed medical conditions (e.g., diabetes, thyroid disease, lyme disease) will be considered for exclusion after consultation with the PI and medical monitor. We ask a variety of questions about participants' medical conditions that are not necessarily exclusionary to be able to consult with the medical monitor about these conditions. Participants with any medical condition/medication that may affect participant safety, study outcomes, or biomarker data will be excluded based on these consultations.
Individuals with current, diagnosed, uncontrolled psychiatric conditions will be excluded. A controlled psychiatric illness is defined as one where the individual is taking medication and/or receiving other treatment (e.g., psychotherapy). In addition, individuals who have been to the ER and/or been hospitalized for a psychiatric condition in the past year will be excluded. Individuals with past-month use of cocaine, opioids, benzodiazepines, and methamphetamine or other illegal substances (other than cannabis) will be excluded. Individuals who report using cannabis more than 15 days in the past 30 and/or alcohol more than 25 days in the past 30 days will be excluded.
Participants who choose not to answer questions related to inclusion/exclusion criteria will be excluded.
Participants who indicate their sex assigned at birth is female will be excluded if they are breastfeeding or test positive for pregnancy (by urinalysis) at screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for the Study of Tobacco Products
Richmond, Virginia, 23220

Other trials in United States

About this study

The investigators will compare abuse liability indices between three FDA-authorized ECIG products that vary in nicotine flux (but are all tobacco flavor) and own brand cigarettes. The investigators will also test the influence of ECIG flavor availability (tobacco vs. menthol) within three ECIG product classes.

Conditions: Electronic Cigarette Use
Being tested: Tobacco product administration and assessment
Keywords: Electronic Cigarette, Nicotine Flux, Tobacco Use
Medical subject headings: Vaping, Tobacco Use

What participants receive

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

Tobacco product administration and assessmentOther
Subjective measures 1 is followed by product sampling that includes 5 self-directed ECIG/own brand cigarette puffs over 10 minutes. After sampling is complete participants complete subjective measures 2. Ten minutes after their sampling has been completed, they complete subjective measures 3 and the behavioral economic task(s). These activities are preceded and followed by cardiovascular response assessment.

Study groups in NCT05971823
Study group	Role	What they receive
All Participants	Experimental	All participants will receive the same interventions in the same order. Receives: Other: Tobacco product administration and assessment

What is being measured

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

Intensity of Drug Purchase Task (DPT)
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Order effects are not assessed in this study design.
Intensity, as measured by DPT, is a self-report measure used to assess the reinforcing efficacy or motivational value of a substance. It is a specific quantitative index that refers to the maximum amount of a drug a person would consume if it were available at zero or minimal cost. For this assessment, intensity is measured in puffs (e.g., 0-100 puffs if each puff were free).
Measured: There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.
Price Sensitivity of Drug Purchase Task (DPT)
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Order effects are not assessed in this study design.
Price sensitivity (α; change in amount purchased as price increases) as measured by DPT. By analyzing these metrics, researchers can quantify and compare the motivational strength and reinforcing value of different substances or different doses, providing insight into the overvaluation of drugs that contributes to addiction. (e.g., 0% to 1% range)
DPT outcomes included: breakpoint (highest price participants were willing to pay), intensity (consumption at zero cost), and price sensitivity (α; change in amount purchased as price increases
Measured: There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.
Breakpoint of Drug Purchase Task (DPT)
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Order effects are not assessed in this study design.
Breakpoint, as measured by DPT, is defined as the first price at which a participant's consumption of a hypothetical drug product is suppressed to zero. The DPT is a behavioral economics assessment tool used to measure the reinforcing value (or abuse liability) of substances. Participants are asked to report how much of a drug they would consume at a series of escalating prices, assuming no access to other similar products and that all consumption would occur within a specified time period (e.g., one day). (e.g. $0.00 to $10.00 range)
Measured: There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.
Cross-price Elasticity of the Cross Product-DPT
The Cross Product (CP)-DPTs assess cross-product purchasing behaviors between various tobacco products offered at a fixed amount and own brand cigarettes offered at varying prices. Order effects are not assessed in this study design.
CP-DPT involves participants making two hypothetical choices at once, for a series of price scenarios. For example, participants are asked how many puffs of their Own Brand Cigarette AND how many puffs of a menthol-flavored NJOY Ace 2.4% Nicotine ECIG they would purchase if each Own Brand Cigarette puff cost $0.00 (i.e., free) and each menthol-flavored NJOY Ace 2.4% Nicotine ECIG puff cost $0.10.The outcome of the task is cross-price elasticity.
Measured: There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.

Timeline

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

31 Jul 202326 Jul 2024

First posted2 Aug 2023
Study start31 Jul 2023
Primary completion26 Jul 2024
Study completion26 Jul 2024

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 Electronic Cigarette UseStudies of the same condition, open and under way.
More trials run by Virginia Commonwealth UniversityThe 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: Basic science
Allocation: Not applicable
Intervention model: Single group
Model description: This is a single-arm study. All of the participants will receive the same interventions in the same order.
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05971823
Sponsor's protocol ID: HM20025464
Other IDs: 2U54DA036105
Status last verified: Mar 2026
First submitted: 14 Jul 2023
Last updated: 6 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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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Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
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Recruiting
Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida: The BReATHE Study
Vaping Teens, Vaping Behaviors
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
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All Electronic Cigarette Use trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
ClinicalTrials.gov ID: NCT05971823
Acronym / sponsor ID: HM20025464
Conditions: Electronic Cigarette Use
Keywords: Electronic Cigarette, Nicotine Flux, Tobacco Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 31 Jul 2023 (actual)
Primary completion: 26 Jul 2024 (actual)
Study completion: 26 Jul 2024 (actual)
First posted: 2 Aug 2023 (actual)
Results: Posted 6 Apr 2026

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a single-arm study. All of the participants will receive the same interventions in the same order.

Arm	Type	Receives
All Participants	Experimental	Other: Tobacco product administration and assessmentAll participants will receive the same interventions in the same order.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

healthy (determined by self-report)
at least 18 years old
willing to provide informed consent
able to attend the lab and use designated products according to the study protocol
smoke cigarettes at least 3 days per week, and on those days, at least one cigarette is smoked per day

Key exclusion criteria (6 listed)

Women who are breastfeeding or test positive for pregnancy (by urinalysis) at screening.
Individuals with the following self-reported current, diagnosed medical condition(s) will be excluded automatically: uncontrolled high blood pressure (via self-report or observed at screening; BP must be less than 160/100), heart-related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g., HIV/AIDS, multiple sclerosis), respiratory disorders (e.g., COPD, asthma), kidney diseases, liver diseases (e.g., cirrhosis), or seizures.
Individuals with other self-reported current, diagnosed medical conditions (e.g., diabetes, thyroid disease, lyme disease) will be considered for exclusion after consultation with the PI and medical monitor. We ask a variety of questions about participants' medical conditions that are not necessarily exclusionary to be able to consult with the medical monitor about these conditions. Participants with any medical condition/medication that may affect participant safety, study outcomes, or biomarker data will be excluded based on these consultations.
Individuals with current, diagnosed, uncontrolled psychiatric conditions will be excluded. A controlled psychiatric illness is defined as one where the individual is taking medication and/or receiving other treatment (e.g., psychotherapy). In addition, individuals who have been to the ER and/or been hospitalized for a psychiatric condition in the past year will be excluded. Individuals with past-month use of cocaine, opioids, benzodiazepines, and methamphetamine or other illegal substances (other than cannabis) will be excluded. Individuals who report using cannabis more than 15 days in the past 30 and/or alcohol more than 25 days in the past 30 days will be excluded.
Participants who choose not to answer questions related to inclusion/exclusion criteria will be excluded.

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
Tobacco product administration and assessmentSubjective measures 1 is followed by product sampling that includes 5 self-directed ECIG/own brand cigarette puffs over 10 minutes. After sampling is complete participants complete subjective measures 2. Ten minutes after their sampling has been completed, they complete subjective measures 3 and the behavioral economic task(s). These activities are preceded and followed by cardiovascular response assessment.	Other	All Participants

Primary outcome

Intensity of Drug Purchase Task (DPT)
Time frame: There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Order effects are not assessed in this study design. Intensity, as measured by DPT, is a self-report measure used to assess the reinforcing efficacy or motivational value of a substance. It is a specific quantitative index that refers to the maximum amount of a drug a person would consume if it were available at zero or minimal cost. For this assessment, intensity is measured in puffs (e.g., 0-100 puffs if each puff were free).
Price Sensitivity of Drug Purchase Task (DPT)
Time frame: There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Order effects are not assessed in this study design. Price sensitivity (α; change in amount purchased as price increases) as measured by DPT. By analyzing these metrics, researchers can quantify and compare the motivational strength and reinforcing value of different substances or different doses, providing insight into the overvaluation of drugs that contributes to addiction. (e.g., 0% to 1% range) DPT outcomes included: breakpoint (highest price participants were willing to pay), intensity (consumption at zero cost), and price sensitivity (α; change in amount purchased as price increases
Breakpoint of Drug Purchase Task (DPT)
Time frame: There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Order effects are not assessed in this study design. Breakpoint, as measured by DPT, is defined as the first price at which a participant's consumption of a hypothetical drug product is suppressed to zero. The DPT is a behavioral economics assessment tool used to measure the reinforcing value (or abuse liability) of substances. Participants are asked to report how much of a drug they would consume at a series of escalating prices, assuming no access to other similar products and that all consumption would occur within a specified time period (e.g., one day). (e.g. $0.00 to $10.00 range)
Cross-price Elasticity of the Cross Product-DPT
Time frame: There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.
The Cross Product (CP)-DPTs assess cross-product purchasing behaviors between various tobacco products offered at a fixed amount and own brand cigarettes offered at varying prices. Order effects are not assessed in this study design. CP-DPT involves participants making two hypothetical choices at once, for a series of price scenarios. For example, participants are asked how many puffs of their Own Brand Cigarette AND how many puffs of a menthol-flavored NJOY Ace 2.4% Nicotine ECIG they would purchase if each Own Brand Cigarette puff cost $0.00 (i.e., free) and each menthol-flavored NJOY Ace 2.4% Nicotine ECIG puff cost $0.10.The outcome of the task is cross-price elasticity.

Results and safety

Results posted to the registry on 6 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	30	30

Primary outcome: Intensity of Drug Purchase Task (DPT)

Time frame: There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.. Mean (Standard Deviation). Unit: number of puffs

Measure	All Participants n = 30
Own Brand Cigarette	172.20 (94.90)
NJOY Ace 2.4% Nicotine ECIG - Menthol Flavor	89.90 (97.06)
NJOY Ace 2.4% Nicotine ECIG - Classic Tobacco Flavor	60.83 (78.62)
NJOY Ace 5.0% Nicotine ECIG - Menthol Flavor	94.50 (97.95)
NJOY Ace 5.0% Nicotine ECIG - Classic Tobacco Flavor	70.23 (74.91)
NJOY Daily 6.0% Nicotine ECIG - Menthol Flavor	100.40 (109.33)
NJOY Daily 6.0% Nicotine ECIG - Extra Rich Tobacco Flavor	86.50 (95.65)

Population analysed: Thirty-two subjects were eligible and consented. Thirty participants started and completed the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed in this study design. There were four sessions, for the seven conditions: 1.) own brand (1 condition), 2.) 2.4% (2 conditions), 3.) 5% (2 conditions), and 4.) 6% (2 conditions) .

Primary outcome: Price Sensitivity of Drug Purchase Task (DPT)

Measure	All Participants n = 13
Own Brand Cigarette	.008 (.004)
NJOY Ace 2.4% Nicotine ECIG - Menthol Flavor	.030 (.056)
NJOY Ace 2.4% Nicotine ECIG - Classic Tobacco Flavor	.019 (.021)
NJOY Ace 5.0% Nicotine ECIG - Menthol Flavor	.022 (.050)
NJOY Ace 5.0% Nicotine ECIG - Classic Tobacco Flavor	.013 (.017)
NJOY Daily 6.0% Nicotine ECIG - Menthol Flavor	.027 (.066)
NJOY Daily 6.0% Nicotine ECIG - Extra Rich Tobacco Flavor	.014 (.012)

Population analysed: Thirty-two subjects were eligible and consented. Thirty participants started and completed the study procedures. Study data were collected only from the 30 subjects who participated in the interventions (Demographic and outcome). Order effects are not assessed in this study design. There were four sessions, for the seven conditions: 1.) own brand (1 condition), 2.) 2.4% (2 conditions), 3.) 5% (2 conditions), and 4.) 6% (2 conditions). 13 subjects completed this intervention.

Primary outcome: Breakpoint of Drug Purchase Task (DPT)

Measure	All Participants n = 30
Own Brand Cigarette	1.94 (4.13)
NJOY Ace 2.4% Nicotine ECIG - Menthol Flavor	2.00 (5.19)
NJOY Ace 2.4% Nicotine ECIG - Classic Tobacco Flavor	2.05 (5.20)
NJOY Ace 5.0% Nicotine ECIG - Menthol Flavor	1.60 (3.79)
NJOY Ace 5.0% Nicotine ECIG - Classic Tobacco Flavor	1.89 (5.16)
NJOY Daily 6.0% Nicotine ECIG - Menthol Flavor	1.48 (3.83)
NJOY Daily 6.0% Nicotine ECIG - Extra Rich Tobacco Flavor	1.99 (5.18)

Primary outcome: Cross-price Elasticity of the Cross Product-DPT

Measure	All Participants n = 30
NJOY Ace 2.4% Nicotine ECIG - Menthol Flavor	.149 (.123)
NJOY Ace 2.4% Nicotine ECIG - Classic Tobacco Flavor	.193 (.127)
NJOY Ace 5.0% Nicotine ECIG - Menthol Flavor	.245 (.110)
NJOY Ace 5.0% Nicotine ECIG - Classic Tobacco Flavor	.079 (.111)
NJOY Ace 6.0% Nicotine ECIG - Menthol Flavor	.098 (.141)
NJOY Ace 6.0% Nicotine ECIG - Extra Rich Tobacco Flavor	.202 (.122)

Population analysed: 32 subjects were eligible and consented. Thirty participants started and completed the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed. 4 Sessions/ 7 Conditions: Session 1.) own brand (1 cond), Session 2.) 2.4% (2 condit, Session 3.) 5% (2 condit), and Session 4.) 6% (2 condit). The session timing was not standardized, this is a difficult population to schedule.

Adverse events

Time frame: At baseline and through to the completion of all of the protocol procedures. There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Caroline O Cobb, PhD principal investigator

Virginia Commonwealth University

Andrew Barnes, PhD principal investigator

Virginia Commonwealth 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 Tobacco product administration and assessment in people with Electronic Cigarette Use, run by Virginia Commonwealth 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 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2026. 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?

Yes. Results are posted in the registry (first posted 6 Apr 2026). 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?

Intensity of Drug Purchase Task (DPT) (time frame: There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.). 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?

On the ClinicalTrials.gov record for NCT05971823.

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 6 Apr 2026.