Tobacco UseNCT05320887
Cigarette and E-cigarette Nicotine Content in an Electronic Tobacco Marketplace (ETM)
A study testing Normal Nicotine Content Vape with all flavor e-liquids, Normal nicotine content vape with tobacco e-liquids and Low nicotine content vape with all flavor e-liquids in people with Tobacco Use, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This study is proposing a four condition Electronic Tobacco Marketplace (ETM) study to determine if banning normal nicotine content (NNC) is sufficient for encouraging smokers to switch to potentially less harmful products or if the availability of higher nicotine and/or flavored alternative products (specifically… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Normal Nicotine Content Vape with all flavor e-liquids, Normal nicotine content vape with tobacco e-liquids and Low nicotine content vape with all flavor e-liquids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2022to 6 Aug 2023
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21+ years of age
- Self-report smoking at least 5 cigarettes per day for the past year
- Breathe carbon monoxide (CO) level > 8 ppm or positive urine NicCheck
- Willingness to use other tobacco products during the study
- Speak, comprehend, and read English sufficiently to complete study procedures
- Have home access to a computer, smart phone, or tablet with a web camera and internet access
- Tried a vaping device at least once in their lifetime
Who cannot join
- Currently seeking treatment to quit smoking
- Self-reported serious medical or psychiatric condition(s) including cardiovascular and chronic respiratory diseases
- Body temperature > 100.4 F
- Cold, flu or COVID-19 symptoms including fever, cough, and runny nose in the past 30 days
- Currently pregnant, breastfeeding or intending to become pregnant for the duration of the study or unwilling to agree to use adequate protection to avoid pregnancy
- CO reading > 80 ppm
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: The Impact of Cigarette Nicotine Content, E-Cigarette Nicotine Content and E-Cigarette Flavoring on Smoking Behavior in an Electronic Tobacco Marketplace
This study is proposing a four condition Electronic Tobacco Marketplace (ETM) study to determine if banning normal nicotine content (NNC) is sufficient for encouraging smokers to switch to potentially less harmful products or if the availability of higher nicotine and/or flavored alternative products (specifically e-cigarettes) are needed to achieve maximal reductions in smoking.
Read the detailed description
The Family Smoking Prevention and Tobacco Control Act (FSPTCA) passed in 2009 provides the FDA with the authority to regulate tobacco products. One provision in this legislative act empowers the FDA to set limits on constituents in tobacco products, including nicotine. Such a measure has the potential to reduce the chance of individuals experimenting with smoking from becoming dependent and enable current smokers to quit when they are motivated to do so. Although the proposal to reduce nicotine in cigarettes has been met with skepticism by some because of concerns over compensatory smoking behavior and the potential emergence of a black market, this policy measure was considered to be technically feasible by the American Medical Association and the British Medical, by tobacco control researchers, policymakers and governmental officials who were convened in a meeting on nicotine regulation8, and by the World Health Organization Study Group on Tobacco Product Regulation. Most importantly, in July 2017, FDA Commissioner Gottlieb announced he was "directing our Center for Tobacco Products to develop a comprehensive nicotine regulatory plan premised on the need to confront and alter cigarette addiction." This announcement was followed on March 16, 2018 by the release of the Advance Notice of Proposed Rulemaking entitled "Tobacco Product Standard for Nicotine Level of Combusted Cigarettes" (ID: FDA-2017-N-6189-0001) "to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes."
This study proposes to conduct a within-subjects, multi-session virtual lab study and validation field assessment to determine how the availability of flavored e-liquids affects product purchasing among cigarette smokers. Adult daily cigarette smokers (N=64) will be recruited for this study. After initial eligibility is assessed, participants will complete six virtual sessions (1 baseline, 4 experimental, and 1 follow-up) and one field assessment to evaluate their tobacco use.
- Conditions
- Tobacco Use
- Being tested
- Normal Nicotine Content Vape with all flavor e-liquids, Normal nicotine content vape with tobacco e-liquids, Low nicotine content vape with all flavor e-liquids, Low nicotine content vape with tobacco e-liquids
- Keywords
- Cigarette smoking
- Medical subject headings
- Tobacco Use, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Nicotine Content Vape with all flavor e-liquidsOther
Participants are randomly assigned to the order of each marketplace Group
Normal nicotine content vape with tobacco e-liquidsOther
Participants are randomly assigned to the order of each marketplace Group
Low nicotine content vape with all flavor e-liquidsOther
Participants are randomly assigned to the order of each marketplace Group
Low nicotine content vape with tobacco e-liquidsOther
Participants are randomly assigned to the order of each marketplace Group
| Study group | Role | What they receive |
|---|---|---|
| Normal Nicotine Content Vape with all flavor e-liquids | Experimental | Normal Nicotine Content Vape with all flavor e-liquids Receives: Other: Normal Nicotine Content Vape with all flavor e-liquids |
| Normal nicotine content vape with tobacco e-liquids | Experimental | Normal nicotine content vape with tobacco e-liquids Receives: Other: Normal nicotine content vape with tobacco e-liquids |
| Low nicotine content vape with all flavor e-liquids | Experimental | Low nicotine content vape with all flavor e-liquids Receives: Other: Low nicotine content vape with all flavor e-liquids |
| Low nicotine content vape with tobacco e-liquids | Experimental | Low nicotine content vape with tobacco e-liquids Receives: Other: Low nicotine content vape with tobacco e-liquids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cigarettes Purchased
Average number of cigarettes purchased (analyzed as raw data and using derived behavioral economic measures)
Measured: Visit 6 approximately 4 weeks after baseline
Secondary outcomes (8)
Number of E-liquid Milliliters Purchased
Average number of e-liquid milliliters purchased (analyzed as raw data and using derived behavioral economic measures)
Measured: Visit 6 approximately 4 weeks after baseline
Proportion of Participants Completing Flavor and Nicotine Content Discrete Choice Projections
The proportion of participants projected to choose a cigarette over an e-cigarette under different potential regulatory scenarios, as determined by regression analysis.
Measured: Month 1 after baseline
Lung Cancer Perceived Risk Scores for VLNC Cigarettes
The response options rely on a 10-point Likert-like scale: 1 = very low risk of disease; 2, 3, 4, 5, 6, 7, 8, 9, 10 = very high risk of disease. Minimum possible response 1. Maximum possible response 10. The higher the score, the greater perceived risk of VLNC cigarettes for lung cancer.
Measured: Baseline
Product Evaluation Scale Scores
Product evaluation scale scores for VLNC cigarettes among participants who received VLNC cigarettes will be determined by a product evaluation questionnaire. The questionnaire measures the strength of self-reported positive subjective effects (e.g., reward, satisfaction) following product use. The response options rely on a 7-point Likert-like scale: 1=not at all; 2= very little; 3= a little; 4= moderately; 5= a lot; 6= quite a lot; 7= extremely. The summed score adds responses to 13 separate items. Minimum possible response: 13. Maximum possible response: 91. Higher scores denote more favorable product effects. Note: This was only administered (at Virtual Visit 6) to participants who received each product type in the field (dependent on their baseline ETM shopping trip purchases).
Measured: Visit 6 approximately 4 weeks after baseline
Minnesota Nicotine Withdrawal Scale Scores
Minnesota Nicotine Withdrawal Scale measures the severity of nicotine withdrawal symptoms. The response options rely on a 5-point Likert-like scale; 0=None; 1= Slight; 2=Mild; 3=Moderate; 4=Severe. There are 7 items total, that are summed. Minimum possible response: 0. Maximum possible response: 28. Higher scores denote greater severity of withdrawal symptoms.
Measured: Visit 6 approximately 4 weeks after baseline
Questionnaire on Smoking Urges Score
Questionnaire on Smoking Urges measures the strength of urges to smoke. The response options rely on a 7-point Likert-like scale: 1=Strongly Disagree; 2; 3; 4; 5; 6; 7= Strongly Agree. The questionnaire has 10 total items; scores sum responses to each item. Minimum possible response: 10. Maximum possible response: 70. Higher scores denote greater urges to smoke.
Measured: Visit 6 approximately 4 weeks after baseline
Tobacco Product Interest Scores
Tobacco Product Interest of different products; Slider scale ranging from 0=No Interest to 100=Very Interested
Measured: 1 month after baseline
Tobacco Policy Questionnaire Scores
Tobacco Policy Questionnaire scored from Support, Oppose, and Don't know for personal opinions on Making Cigarettes Less Addictive
Measured: 1 month after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start27 Jul 2022
- Primary completion31 Jul 2023
- Study completion6 Aug 2023
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.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Participants are randomly assigned to either low nicotine or normal nicotine content vaping devices with tobacco flavors only available
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Eric M Donny, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320887
- Sponsor's protocol ID
- IRB00080010
- Other IDs
- 5U54DA031659-09
- Status last verified
- Mar 2023
- First submitted
- 23 Mar 2022
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jarvis MJ, Bates C. Eliminating nicotine in cigarettes. Tob Control. 1999 Spring;8(1):106-7; author reply 107-9. No abstract available.
PubMed 10465828Kozlowski LT. Prospects for a nicotine-reduction strategy in the cigarette endgame: Alternative tobacco harm reduction scenarios. Int J Drug Policy. 2015 Jun;26(6):543-7. doi: 10.1016/j.drugpo.2015.02.001. Epub 2015 Feb 23.
PubMed 25795345Kozlowski LT. Cigarette prohibition and the need for more prior testing of the WHO TobReg's global nicotine-reduction strategy. Tob Control. 2017 Mar;26(e1):e31-e34. doi: 10.1136/tobaccocontrol-2016-052995. Epub 2016 Jun 29. No abstract available.
PubMed 27357937Kozlowski LT. Let actual markets help assess the worth of optional very-low-nicotine cigarettes before deciding on mandatory regulations. Addiction. 2017 Jan;112(1):3-5. doi: 10.1111/add.13515. Epub 2016 Aug 23. No abstract available.
PubMed 27554993Shatenstein S. Eliminating nicotine in cigarettes. Tob Control. 1999 Spring;8(1):106; author reply 107-9. No abstract available.
PubMed 10465827Henningfield JE, Benowitz NL, Slade J, Houston TP, Davis RM, Deitchman SD. Reducing the addictiveness of cigarettes. Council on Scientific Affairs, American Medical Association. Tob Control. 1998 Autumn;7(3):281-93. doi: 10.1136/tc.7.3.281.
PubMed 9825424Hatsukami DK, Perkins KA, Lesage MG, Ashley DL, Henningfield JE, Benowitz NL, Backinger CL, Zeller M. Nicotine reduction revisited: science and future directions. Tob Control. 2010 Oct;19(5):e1-10. doi: 10.1136/tc.2009.035584.
PubMed 20876072World Health Organization. WHO STUDY GROUP ON TOBACCO PRODUCT REGULATION. Report on the Scientific Basis of Tobacco Product Regulations: Fifth Report of a WHO Study Group. World Health Organ Tech Rep Ser. 2015;(989):1-234, back cover.
PubMed 26353746
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cigarette Nicotine Content, E-Cigarette Nicotine Content and E-Cigarette Flavoring on Smoking Behavior in an Electronic Tobacco Marketplace
- ClinicalTrials.gov ID
- NCT05320887
- Acronym / sponsor ID
- IRB00080010
- Conditions
- Tobacco Use
- Keywords
- Cigarette smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 6 Aug 2023 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Posted 9 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is proposing a four condition Electronic Tobacco Marketplace (ETM) study to determine if banning normal nicotine content (NNC) is sufficient for encouraging smokers to switch to potentially less harmful products or if the availability of higher nicotine and/or flavored alternative products (specifically e-cigarettes) are needed to achieve maximal reductions in smoking.
Detailed description
The Family Smoking Prevention and Tobacco Control Act (FSPTCA) passed in 2009 provides the FDA with the authority to regulate tobacco products. One provision in this legislative act empowers the FDA to set limits on constituents in tobacco products, including nicotine. Such a measure has the potential to reduce the chance of individuals experimenting with smoking from becoming dependent and enable current smokers to quit when they are motivated to do so. Although the proposal to reduce nicotine in cigarettes has been met with skepticism by some because of concerns over compensatory smoking behavior and the potential emergence of a black market, this policy measure was considered to be technically feasible by the American Medical Association and the British Medical, by tobacco control researchers, policymakers and governmental officials who were convened in a meeting on nicotine regulation8, and by the World Health Organization Study Group on Tobacco Product Regulation. Most importantly, in July 2017, FDA Commissioner Gottlieb announced he was "directing our Center for Tobacco Products to develop a comprehensive nicotine regulatory plan premised on the need to confront and alter cigarette addiction." This announcement was followed on March 16, 2018 by the release of the Advance Notice of Proposed Rulemaking entitled "Tobacco Product Standard for Nicotine Level of Combusted Cigarettes" (ID: FDA-2017-N-6189-0001) "to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes."
This study proposes to conduct a within-subjects, multi-session virtual lab study and validation field assessment to determine how the availability of flavored e-liquids affects product purchasing among cigarette smokers. Adult daily cigarette smokers (N=64) will be recruited for this study. After initial eligibility is assessed, participants will complete six virtual sessions (1 baseline, 4 experimental, and 1 follow-up) and one field assessment to evaluate their tobacco use.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Participants are randomly assigned to either low nicotine or normal nicotine content vaping devices with tobacco flavors only available
| Arm | Type | Receives |
|---|---|---|
| Normal Nicotine Content Vape with all flavor e-liquids | Experimental | Other: Normal Nicotine Content Vape with all flavor e-liquidsNormal Nicotine Content Vape with all flavor e-liquids |
| Normal nicotine content vape with tobacco e-liquids | Experimental | Other: Normal nicotine content vape with tobacco e-liquidsNormal nicotine content vape with tobacco e-liquids |
| Low nicotine content vape with all flavor e-liquids | Experimental | Other: Low nicotine content vape with all flavor e-liquidsLow nicotine content vape with all flavor e-liquids |
| Low nicotine content vape with tobacco e-liquids | Experimental | Other: Low nicotine content vape with tobacco e-liquidsLow nicotine content vape with tobacco e-liquids |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 21+ years of age
- Self-report smoking at least 5 cigarettes per day for the past year
- Breathe carbon monoxide (CO) level > 8 ppm or positive urine NicCheck
- Willingness to use other tobacco products during the study
- Speak, comprehend, and read English sufficiently to complete study procedures
Key exclusion criteria (6 listed)
- Currently seeking treatment to quit smoking
- Self-reported serious medical or psychiatric condition(s) including cardiovascular and chronic respiratory diseases
- Body temperature > 100.4 F
- Cold, flu or COVID-19 symptoms including fever, cough, and runny nose in the past 30 days
- Currently pregnant, breastfeeding or intending to become pregnant for the duration of the study or unwilling to agree to use adequate protection to avoid pregnancy
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 |
|---|---|---|
| Normal Nicotine Content Vape with all flavor e-liquidsParticipants are randomly assigned to the order of each marketplace Group | Other | Normal Nicotine Content Vape with all flavor e-liquids |
| Normal nicotine content vape with tobacco e-liquidsParticipants are randomly assigned to the order of each marketplace Group | Other | Normal nicotine content vape with tobacco e-liquids |
| Low nicotine content vape with all flavor e-liquidsParticipants are randomly assigned to the order of each marketplace Group | Other | Low nicotine content vape with all flavor e-liquids |
| Low nicotine content vape with tobacco e-liquidsParticipants are randomly assigned to the order of each marketplace Group | Other | Low nicotine content vape with tobacco e-liquids |
Primary outcome
Number of Cigarettes Purchased
Time frame: Visit 6 approximately 4 weeks after baseline
Average number of cigarettes purchased (analyzed as raw data and using derived behavioral economic measures)
8 secondary outcomes
Number of E-liquid Milliliters Purchased
Time frame: Visit 6 approximately 4 weeks after baseline
Proportion of Participants Completing Flavor and Nicotine Content Discrete Choice Projections
Time frame: Month 1 after baseline
Lung Cancer Perceived Risk Scores for VLNC Cigarettes
Time frame: Baseline
Product Evaluation Scale Scores
Time frame: Visit 6 approximately 4 weeks after baseline
Minnesota Nicotine Withdrawal Scale Scores
Time frame: Visit 6 approximately 4 weeks after baseline
Questionnaire on Smoking Urges Score
Time frame: Visit 6 approximately 4 weeks after baseline
Tobacco Product Interest Scores
Time frame: 1 month after baseline
Tobacco Policy Questionnaire Scores
Time frame: 1 month after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10465828Jarvis MJ, Bates C. Eliminating nicotine in cigarettes. Tob Control. 1999 Spring;8(1):106-7; author reply 107-9. No abstract available.
- Background: PubMed 25795345Kozlowski LT. Prospects for a nicotine-reduction strategy in the cigarette endgame: Alternative tobacco harm reduction scenarios. Int J Drug Policy. 2015 Jun;26(6):543-7. doi: 10.1016/j.drugpo.2015.02.001. Epub 2015 Feb 23.
- Background: PubMed 27357937Kozlowski LT. Cigarette prohibition and the need for more prior testing of the WHO TobReg's global nicotine-reduction strategy. Tob Control. 2017 Mar;26(e1):e31-e34. doi: 10.1136/tobaccocontrol-2016-052995. Epub 2016 Jun 29. No abstract available.
- Background: PubMed 27554993Kozlowski LT. Let actual markets help assess the worth of optional very-low-nicotine cigarettes before deciding on mandatory regulations. Addiction. 2017 Jan;112(1):3-5. doi: 10.1111/add.13515. Epub 2016 Aug 23. No abstract available.
- Background: PubMed 10465827Shatenstein S. Eliminating nicotine in cigarettes. Tob Control. 1999 Spring;8(1):106; author reply 107-9. No abstract available.
- Background: PubMed 9825424Henningfield JE, Benowitz NL, Slade J, Houston TP, Davis RM, Deitchman SD. Reducing the addictiveness of cigarettes. Council on Scientific Affairs, American Medical Association. Tob Control. 1998 Autumn;7(3):281-93. doi: 10.1136/tc.7.3.281.
- Background: PubMed 20876072Hatsukami DK, Perkins KA, Lesage MG, Ashley DL, Henningfield JE, Benowitz NL, Backinger CL, Zeller M. Nicotine reduction revisited: science and future directions. Tob Control. 2010 Oct;19(5):e1-10. doi: 10.1136/tc.2009.035584.
- Background: PubMed 26353746World Health Organization. WHO STUDY GROUP ON TOBACCO PRODUCT REGULATION. Report on the Scientific Basis of Tobacco Product Regulations: Fifth Report of a WHO Study Group. World Health Organ Tech Rep Ser. 2015;(989):1-234, back cover.
- 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.
Eric M Donny, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Nicotine Content Vape with all flavor e-liquids, Normal nicotine content vape with tobacco e-liquids and Low nicotine content vape with all flavor e-liquids in people with Tobacco Use, run by Wake Forest University Health Sciences 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 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 9 Oct 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. 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 9 Oct 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?
Number of Cigarettes Purchased (time frame: Visit 6 approximately 4 weeks after baseline). 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 NCT05320887, which also lists 8 linked publications.
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 9 Oct 2024.