Tobacco UseNCT03682900
Expanding the Click City Tobacco Prevention Program to Include E-cigarettes and Other Novel Tobacco Products
A study testing Click City®: Tobacco and Usual Tobacco Curriculum in people with Tobacco Use, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.
Trial summary
The goal of this study is to modify a smoking prevention program for 5th and 6th grade students to also target vaping e-cigarettes. Aims were to modify the program along with associated materials and to conduct a trial with 5th grade students in the school setting to see how well the updated program worked. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Click City®: Tobacco and Usual Tobacco Curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,673 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A 5th grade student in one of the recruited schools
- Student speaks English as a first or second language
- Passive parental consent to participate
Who cannot join
- Special needs students identified by the classroom teacher as a student who would not understand the questionnaire or the program
- Teacher indicates that they cannot comprehend English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Research Behavioral Intervention Strategies, Inc.
Springfield, Oregon, 97477
About this study
The goal of this study is to modify a smoking prevention program for 5th and 6th grade students to also target vaping e-cigarettes. Aims were to modify the program along with associated materials and to conduct a trial with 5th grade students in the school setting to see how well the updated program worked. Students either participated in the four-week computer based program or continued with their usual tobacco prevention curriculum.
This study showed that students who received the computer program reduced their intentions and willingness to use e-cigarettes or smoke in the future more than did students who used their usual tobacco curriculum.
Read the detailed description
Given the increase in prevalence of e-cigarette use among youth, investigators modified a smoking prevention program to not only target smoking but also vaping e-cigarettes. Investigators conducted a pragmatic randomized trial with 5th grade students in schools across Arizona and Oregon to evaluate the effectiveness of the updated program in a "real-world" setting. Forty-five schools were randomized to the intervention condition, wherein students used the updated version of Click City®: Tobacco, or the control condition, wherein students were taught their usual tobacco prevention curriculum. Students in the intervention schools decreased their intentions and willingness to use e-cigarettes and cigarettes significantly, as compared to students in control schools. The intervention also significantly changed all etiological mechanisms. The effects on all outcomes of the intervention were similar as a function of state (Arizona vs Oregon), gender, ethnicity (Hispanic vs not Hispanic), and historical timing (prior to school closures in 2020 vs after schools re-opened in 2022). The intervention was also more effective for at-risk students, as defined by student's previous tobacco use, current family use and/or high in sensation seeking. Close to 90% of the students completed the entire program, and most completed it in 3 to 4 weeks, the expected time frame. The effectiveness of the updated Click City®: Tobacco was demonstrated in a "real world" setting and findings suggested that all students can potentially benefit from the program.
- Conditions
- Tobacco Use
- Being tested
- Click City®: Tobacco, Usual Tobacco Curriculum
- Keywords
- e-cigarettes, prevention, middle school, smoking
- Medical subject headings
- Tobacco Use, Vaping, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Click City®: TobaccoOther
A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.
Usual Tobacco CurriculumOther
Students complete their usual curriculum designed to prevent tobacco use.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Click City Tobacco Prevention Program | Experimental | Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Receives: Other: Click City®: Tobacco |
| Control: Usual Tobacco Prevention Curriculum | Experimental | Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Receives: Other: Usual Tobacco Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Behavioral Intentions to Vape E-cigarettes
Measured by two items, assessing the student's intentions regarding vaping e-cigarettes as a teen or as a grown-up. Responses were on a five-point scale ranging from "definitely not" (1) to "definitely will" (5). The scale was created by summing the two items with potential range from 2 to 10. A higher score means a worse outcome.
Measured: baseline; six months
Change in Behavioral Intentions to Smoke Cigarettes
Measured by two items assessing the student's intentions to smoke cigarettes as a teen or as a grown-up. Responses were on a five-point scale ranging from "definitely not" (1) to "definitely will" (5). The scale was created by summing the two items with a potential range from 2 to 10. A higher score means a worse outcome.
Measured: baseline; six weeks
Change in Willingness to Vape E-cigarettes
Measured by four items, assessing the student's willingness to vape e-cigarettes if the opportunity presented itself (with a group of kids with e-cigaretes available and with kids who are vaping and you want to be a part of the group. Willingness to vape was assessed for two levels, "try a few vapes" and "try vaping several times in a row". Responses were on a five point scale, "not at all willing" (1) to "very willing" (5) and were summed for the two scenarios and two levels, yielding a scale from 4 to 20. A higher score means a worse outcome.
Measured: baseline; six weeks
Change in Willingness to Smoke Cigarettes
Measured by four items, assessing the student's willingness to smoke cigarettes if the opportunity presented itself ("with a group of kids with cigarettes available" and "with kids who are smoking and you want to be a part of the group". Willingness to smoke was assessed for two levels, "try a few puffs" and "smoking the whole cigarette". Responses were on a five point scale, "not at all willing" (1) to "very willing" (5) and were summed for the two scenarios and two levels, yielding a scale from 4 to 20. A higher score means a worse outcome.
Measured: baseline; six weeks
Secondary outcomes (18)
Change in Favorable Social Images of Smokers
Students rate what they "think kids who smoke are like" using a three-point rating scale from "not at all like this" (1) to "very much like this" (3) to rate three attributes, "popular", "cool or neat" and "exciting". The three attributes are summed and the potential score goes from 3 to 9. A higher score means a worse outcome.
Measured: baseline; six weeks
Change in Favorable Social Images of E-cigarette Vapers
Students rate what they "think kids who vape e-carettes are like" using a three-point rating scale using "not at all like this" (1) to "very much like this" (3) to rate three attributes, "popular", "cool or neat" and "exciting". The three attributes are summed and the potential score ranges from 3 to 9. A higher score means a worse outcome.
Measured: baseline; six weeks
Change in Normative Social Images of Smokers
Students rate what they "think other 5th grade kids think kids who smoke cigarettes are like" using a three-point rating scale using "not at all like this" (1) to "very much like this" (3) to rate three attributes, "popular", "cool or neat" and "exciting". The three attributes are summed and the potential score ranges from 3 to 9. A higher score means a worse outcome.
Measured: baseline; six weeks
Change in Normative Social Images of Vapers
Students rate what they "think other 5th grade kids think kids who vape e-cigarettes are like" using a three-point rating scale using "not at all like this" (1) to "very much like this" (3) to rate three attributes, "popular", "cool or neat" and "exciting". The three attributes are summed and the potential score ranges from 3 to 9. A higher score means a worse outcome.
Measured: baseline; six weeks
Change in Perception of Friends Approval of Smoking
Students indicated their perception of friends' approval of their smoking of each of three levels of cigarettes, trying, smoking a few, and smoking a few a day. Responses to each item ranged from "yes" (1) to "no" (3). Summing the three levels ranged from 3 to 9, with a higher score means a better outcome.
Measured: baseline; six weeks
Change in Perception of Friends Approval of Vaping
Students indicated their perception of friends' approval of their vaping of each of three levels of cigarettes, trying, vaping a few, and vaping a few a day. Responses to each item ranged from "yes" (1) to "no" (3). Summing the three levels ranged from 3 to 9, with a higher score indicating a better outcome.
Measured: baseline; six weeks
Change in Perception of Risk of Second-hand Smoke Exposure
Perception of the risk of getting four diseases ("breathing problems", "asthma", "ear infections" "heart disease", and "lung disease or cancer") as a result of being "often around someone who smokes". Responses for each disease are on a five point scale ranging from "no chance" (1) to "certain to happen" (5). Items were summed to form a scale. The total scale of five items ranged from 4 to 20. A higher score means a better outcome.
Measured: baseline; six weeks
Change in Perception of Risk of Second-hand Vape Exposure
Perception of the risk of getting each of four diseases ("breathing problems", "asthma", "ear infections" , and "lung disease or cancer") as a result of being "often around someone who vapes". Responses for each disease are on a five point scale ranging from "no chance" (1) to "certain to happen" (5). Items were summed to form a scale. The total scale of four items ranged from 4 to 20. The follow-up measure was subtracted from the baseline measure, with a higher score indicating a favorable outcome.
Measured: baseline; six weeks
Change in Perception of Risk of Cumulative Consequences of Smoking
Perception of risk of getting three diseases (lung cancer, serious breathing diseases, and heart disease) as a result of three levels of cigarettes, "one", "a few cigarettes a day for two years", "a pack of cigarettes a day for two years". Responses for each disease and each level ranged from "no chance" (1) to "certain to happen" (5). Items were summed to form a scale. The total scale of nine items ranged from 9 to 45. A higher score means a better outcome.
Measured: baseline; six weeks
Change in Perception of Risk of Cumulative Consequences of Vaping
Perception of risk of getting three diseases (lung cancer, serious breathing diseases, and heart disease) as a result of three levels of e-cigarettes, "one time", "a few times a day for two years", "Twenty or more times a day for two years'. Responses for each disease and each level ranged from "no chance" (1) to "certain to happen" (5). Items were summed to form a scale. The total scale of nine items ranged from 9 to 45. A higher score means a better outcome.
Measured: baseline; six weeks
Change in Perception of Risk of Smoking Each Cigarette
Risk of smoking each cigarette was measured by two items indicating what would happen to a 12 year old who started smoking, "every cigarette smoked hurts them a bit" and "The very next cigarette probably won't hurt their bodies". The response scale was a five-point scale ranging from "strongly agree" (1) to "strongly disagree" (5). The scale consisted of summing both items with the former item reversed scored. Scale scores ranged from 2 to 10. A higher score indicated a more favorable outcome.
Measured: baseline; six weeks
Change in Perception of Risk of Vaping Each E-cigarette
Risk of vaping each e-cigarette was measured by two items indicating what would happen to a 12 year old who started vaping, "every e-cigarette vaped hurts them a bit" and "the very next e-cigarette probably won't hurt their bodies". The response scale was a five-point scale ranging from "strongly agree" (1) to "strongly disagree" (5). The scale consisted of summing both items with the former item reversed scored. Scale scores ranged from 2 to 10. A higher score indicated a more better outcome.
Measured: baseline; six weeks
Change in Perception of Risk of Addiction From Smoking
Change in perception of risk of getting addicted to smoking as a result of five levels of smoking, ranging from "one time" to a "a pack of cigarettes a day for five years". Responses for each level were on a five-point scale ranging from "no chance" (1) to "certain to happen" (5). Items were summed to form a scale. The total scale of the five items ranged from 5 to 25. A higher score means a better outcome.
Measured: baseline; six weeks
Change in Perception of Risk of Addiction From Vaping
Perception of risk of getting addicted to vaping as a result of vaping five levels of increasing quantities of e-cigarettes, ranging from "one time" to a "20 times a day for 5 years". Responses for each level were on a five-point scale ranging from "no chance" (1) to "certain to happen" (5). Items were summed to form a scale. The total scale ranged from 5 to 25. A higher score means a better outcome.
Measured: baseline; six weeks
Change in Perception of Control Over Quitting Smoking
Students answered "how much control do you think you would have over quitting smoking" using a four-point response scale ranging from "no control" (1) to "total control" (4). Perception of control was indicated within four levels of increasing quantities of cigarettes, ranging from "tried a cigarette" to "a pack a day for five years". The four Items were summed to form a scale with the total scale ranging from 4 to 16. A higher score means a worse outcome.
Measured: baseline; six weeks
Change in Perception of Control Over Vaping
Students answered "how much control do you think you would have over quitting vaping e-cigarettes" using a four-point response scale ranging from "no control" (1) to "total control" (4). Students indicated thier perception of control within each of four levels of increasing quantities of e-cigarettes, ranging from "tried vaping" to "20 times a day for five years". The four Items were summed to form a scale with the total scale ranging from 4 to 16. A lower score indicated a better outcome.
Measured: baseline; six weeks
Change in Perception of Risk of Difficulty Quitting Smoking
Perception of risk of difficulty quitting smoking as a result of vaping five levels of increasing quantities of cigarettes smoked, ranging from "one cigarette" to a " a pack of cigarettes a day for 5 years". Responses for each level were on a five-point scale ranging from "Very easy" (1) to "Very difficult" (5). Items were summed to form a scale. The total scale ranged from 5 to 25. A higher score meant a better outcome.
Measured: baseline; six weeks
Change in Perception of Risk of Difficulty Quitting Vaping
Perception of risk of difficulty of quitting vaping as a result of vaping five levels of increasing quantities of e-cigarettes vaped, ranging from "one time" to a " 20 times a day for 5 years". Responses for each level were on a five-point scale ranging from "Very easy" (1) to "Very difficult" (5). Items were summed to form a scale. The total scale ranged from 5 to 25. A higher score means a better outcome.
Measured: baseline; six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Oct 2019
- Primary completion15 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Schools were stratified by state, size of school (small, medium, large) and desired start date and randomized to intervention or control. Intervention and control schools were yoked for the timing of assessments (baseline and follow-up assessments).
- Masking
- None (open label)
- Enrolment
- 2,673 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Judy A Andrews, PhD, Principal investigator, Oregon Research Behavioral Intervention Strategies, Inc.Judith S. Gordon, PhD, Principal investigator, University of Arizon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682900
- Sponsor's protocol ID
- DA044025
- Other IDs
- 2R44DA044025
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2018
- Last updated
- 1 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding the Click City Tobacco Prevention Program to Include E-cigarettes and Other Novel Tobacco Products
- ClinicalTrials.gov ID
- NCT03682900
- Acronym / sponsor ID
- DA044025
- Conditions
- Tobacco Use
- Keywords
- e-cigarettes, prevention, middle school, smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,673 participants (actual)
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Posted 1 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to modify a smoking prevention program for 5th and 6th grade students to also target vaping e-cigarettes. Aims were to modify the program along with associated materials and to conduct a trial with 5th grade students in the school setting to see how well the updated program worked. Students either participated in the four-week computer based program or continued with their usual tobacco prevention curriculum.
This study showed that students who received the computer program reduced their intentions and willingness to use e-cigarettes or smoke in the future more than did students who used their usual tobacco curriculum.
Detailed description
Given the increase in prevalence of e-cigarette use among youth, investigators modified a smoking prevention program to not only target smoking but also vaping e-cigarettes. Investigators conducted a pragmatic randomized trial with 5th grade students in schools across Arizona and Oregon to evaluate the effectiveness of the updated program in a "real-world" setting. Forty-five schools were randomized to the intervention condition, wherein students used the updated version of Click City®: Tobacco, or the control condition, wherein students were taught their usual tobacco prevention curriculum. Students in the intervention schools decreased their intentions and willingness to use e-cigarettes and cigarettes significantly, as compared to students in control schools. The intervention also significantly changed all etiological mechanisms. The effects on all outcomes of the intervention were similar as a function of state (Arizona vs Oregon), gender, ethnicity (Hispanic vs not Hispanic), and historical timing (prior to school closures in 2020 vs after schools re-opened in 2022). The intervention was also more effective for at-risk students, as defined by student's previous tobacco use, current family use and/or high in sensation seeking. Close to 90% of the students completed the entire program, and most completed it in 3 to 4 weeks, the expected time frame. The effectiveness of the updated Click City®: Tobacco was demonstrated in a "real world" setting and findings suggested that all students can potentially benefit from the program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Schools were stratified by state, size of school (small, medium, large) and desired start date and randomized to intervention or control. Intervention and control schools were yoked for the timing of assessments (baseline and follow-up assessments).
| Arm | Type | Receives |
|---|---|---|
| Intervention: Click City Tobacco Prevention Program | Experimental | Other: Click City®: TobaccoParticipation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. |
| Control: Usual Tobacco Prevention Curriculum | Experimental | Other: Usual Tobacco CurriculumStudents in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- A 5th grade student in one of the recruited schools
- Student speaks English as a first or second language
- Passive parental consent to participate
Key exclusion criteria (2 listed)
- Special needs students identified by the classroom teacher as a student who would not understand the questionnaire or the program
- Teacher indicates that they cannot comprehend English.
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 |
|---|---|---|
| Click City®: TobaccoA computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks. | Other | Intervention: Click City Tobacco Prevention Program |
| Usual Tobacco CurriculumStudents complete their usual curriculum designed to prevent tobacco use. | Other | Control: Usual Tobacco Prevention Curriculum |
Primary outcome
Change in Behavioral Intentions to Vape E-cigarettes
Time frame: baseline; six months
Measured by two items, assessing the student's intentions regarding vaping e-cigarettes as a teen or as a grown-up. Responses were on a five-point scale ranging from "definitely not" (1) to "definitely will" (5). The scale was created by summing the two items with potential range from 2 to 10. A higher score means a worse outcome.
Change in Behavioral Intentions to Smoke Cigarettes
Time frame: baseline; six weeks
Measured by two items assessing the student's intentions to smoke cigarettes as a teen or as a grown-up. Responses were on a five-point scale ranging from "definitely not" (1) to "definitely will" (5). The scale was created by summing the two items with a potential range from 2 to 10. A higher score means a worse outcome.
Change in Willingness to Vape E-cigarettes
Time frame: baseline; six weeks
Measured by four items, assessing the student's willingness to vape e-cigarettes if the opportunity presented itself (with a group of kids with e-cigaretes available and with kids who are vaping and you want to be a part of the group. Willingness to vape was assessed for two levels, "try a few vapes" and "try vaping several times in a row". Responses were on a five point scale, "not at all willing" (1) to "very willing" (5) and were summed for the two scenarios and two levels, yielding a scale from 4 to 20. A higher score means a worse outcome.
Change in Willingness to Smoke Cigarettes
Time frame: baseline; six weeks
Measured by four items, assessing the student's willingness to smoke cigarettes if the opportunity presented itself ("with a group of kids with cigarettes available" and "with kids who are smoking and you want to be a part of the group". Willingness to smoke was assessed for two levels, "try a few puffs" and "smoking the whole cigarette". Responses were on a five point scale, "not at all willing" (1) to "very willing" (5) and were summed for the two scenarios and two levels, yielding a scale from 4 to 20. A higher score means a worse outcome.
18 secondary outcomes
Change in Favorable Social Images of Smokers
Time frame: baseline; six weeks
Change in Favorable Social Images of E-cigarette Vapers
Time frame: baseline; six weeks
Change in Normative Social Images of Smokers
Time frame: baseline; six weeks
Change in Normative Social Images of Vapers
Time frame: baseline; six weeks
Change in Perception of Friends Approval of Smoking
Time frame: baseline; six weeks
Change in Perception of Friends Approval of Vaping
Time frame: baseline; six weeks
Change in Perception of Risk of Second-hand Smoke Exposure
Time frame: baseline; six weeks
Change in Perception of Risk of Second-hand Vape Exposure
Time frame: baseline; six weeks
Change in Perception of Risk of Cumulative Consequences of Smoking
Time frame: baseline; six weeks
Change in Perception of Risk of Cumulative Consequences of Vaping
Time frame: baseline; six weeks
Change in Perception of Risk of Smoking Each Cigarette
Time frame: baseline; six weeks
Change in Perception of Risk of Vaping Each E-cigarette
Time frame: baseline; six weeks
Change in Perception of Risk of Addiction From Smoking
Time frame: baseline; six weeks
Change in Perception of Risk of Addiction From Vaping
Time frame: baseline; six weeks
Change in Perception of Control Over Quitting Smoking
Time frame: baseline; six weeks
Change in Perception of Control Over Vaping
Time frame: baseline; six weeks
Change in Perception of Risk of Difficulty Quitting Smoking
Time frame: baseline; six weeks
Change in Perception of Risk of Difficulty Quitting Vaping
Time frame: baseline; six weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- 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.
Judy A Andrews, PhD principal investigator
Oregon Research Behavioral Intervention Strategies, Inc.
Judith S. Gordon, PhD principal investigator
University of Arizon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Click City®: Tobacco and Usual Tobacco Curriculum in people with Tobacco Use, run by Oregon Research Behavioral Intervention Strategies, Inc. 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 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Behavioral Intentions to Vape E-cigarettes (time frame: baseline; six months). 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?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.