Healthy VolunteersNCT05669716
Adolescent Vaping Characterization and Parent Views on Adolescent Vaping Protocol
An observational study of Healthy Volunteers and Vaping Teens, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: The use of electronic cigarettes (vaping) has increased among adolescents over the past decade. Vaping raises many health concerns. People who vape inhale toxic chemicals. Vaping is also linked with mental health issues, such as depression and suicide risk. Read more about this study
- Who is it for?
- Ages 13 to 120 years
- Conditions the study is for
- Healthy Volunteers, Vaping Teens
- How many people
- 726 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2023to 25 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adolescent and parent participants will be enrolled in the survey through the internet, via their own smartphone/computer/tablet device.
Who may be able to join
- In order to be eligible to participate in this study, an individual must:
- Be an adolescent age 13-18 and in grades 8-12 or the summer after graduation, OR an adult who identifies as parenting an adolescent aged 13-18 and in grades 8-12 or the summer after graduation whom they know/suspect is vaping or never has vaped. All participants must be willing to complete the survey to the end.
Who cannot join
- Non-English speakers cannot participate in this study. Justification: The questionnaires from which the survey is constructed are not all validated in languages other than English. We do not have the resources to translate the consent and surveys.
- Those who cannot demonstrate understanding of the purpose of the survey by answering questions after a brief explanation will be excluded. Justification: The ability to understand the purpose of the survey is required in order to provide informed consent to participate and to be able to provide meaningful answers to the survey questions.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse
Baltimore, Maryland, 21224
About this study
Background:
The use of electronic cigarettes (vaping) has increased among adolescents over the past decade. Vaping raises many health concerns. People who vape inhale toxic chemicals. Vaping is also linked with mental health issues, such as depression and suicide risk. In one survey, 85% of young adults reported that they used both vaping and tobacco products; the primary reason they cited for using these products was stress.
Read more
Objective:
This natural history study will survey adolescents and their parents about their attitudes toward vaping.
Eligibility:
People aged 13 to 18, including those who vape; those who once vaped; and those who have never vaped. Parents of people aged 13 to 18 who are known or suspected of vaping are also needed.
Design:
Participants will take a survey. They will use their own smartphone, computer, or tablet to answer questions. The survey will take about 20 minutes. Their answers will be anonymous.
Teenage participants will answer questions on different topics:
Vaping habits, such as when and how they vape.
Drug use, including nicotine, cannabis, and alcohol.
Mood issues, such as depression, anxiety, and stress.
Social influences on vaping, including perceived attitudes of parents and peers.
Other leisure habits, including online gaming and use of social media.
Parents will answer similar questions.
A phone number and links will be given to participants who need help for suicidal thoughts. Other links will be given to those who want help with parenting resources or aids to quit vaping.
Participants may be invited to take part in an 8-week course on mindfulness-based stress reduction.
Participants who finish the survey will receive 10 dollars.
...
Read the detailed description
Study Description: This protocol will explore characteristics of adolescents who vape and the attitudes of adolescents and parents of adolescents who vape towards adolescent vaping, focusing on the Baltimore area. Hypotheses: (Adolescent) Currently vaping adolescents will not view vaping as a problem for which they seek help and will have more mental health symptoms than non-vaping adolescents, while non-vaping adolescents will view vaping more negatively with formerly vaping adolescents scoring between the currently vaping and non-vaping adolescent groups. (Parent) Parents who vape will be more likely to approve of their adolescent s vaping than non-vaping parents.
Objectives:
Primary Objective: To characterize adolescent vaping patterns, overall drug use, perceived stress, and awareness of mindfulness meditation.
Secondary Objectives: To characterize the mental health symptoms of currently vaping, formerly vaping and non-vaping adolescents, and to characterize parent attitudes towards their adolescent s vaping.
Endpoints:
Primary Endpoint: An adequate description of adolescent vapers habits and attitudes towards their vaping.
Secondary Endpoints: An adequate comparison of adolescent vapers, former vapers and non-vapers and of parental attitudes towards adolescent vapers.
- Conditions
- Healthy Volunteers, Vaping Teens
- Keywords
- Vape, Nicotine, Teen, Drug Use, Natural History
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| parents of teens who vape | 400 parent participants, defined as an adult who identifies as parenting an adolescent aged 13-17 whom they know/suspect is vaping. | |
| teens who formerly vaped | Adolescents N=400 (formerly vaped) | |
| teens who never vaped | Adolescents N=400 (never vaped). | |
| teens who vape | adolescent participants (minor subjects), comprised of N=400 (currently vaping, defined as vaping at least one day in the previous 30-day period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitude toward vaping
An adequate description of adolescent vapers habits and attitudes towards their vaping.
Measured: at time of survey
Secondary outcomes (2)
characteristics of parents of teens who vape
parental attitudes towards adolescent vapers.
Measured: at time of survey
comparison of vaping and non-vaping teens on mental health and other drug use
An adequate comparison of adolescent vapers, former vapers and non-vapers on mental health and other drug use.
Measured: at time of survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2023
- Study start9 Mar 2023
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Why it stopped: Principal Investigator is leaving NIDA.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 726 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Betty Jo Salmeron, M.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669716
- Sponsor's protocol ID
- 10001196
- Other IDs
- 001196-DA
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2022
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We plan to share data as specified in the protocol and potentially through future data transfer agreement(s). Any shared data will be stripped of identifiers prior to release for sharing. Deidentified data may be shared with properly administered databases and/or with collaborators with whom proper data sharing agreements are in place. Outside of the data sharing plan already specified in the protocol (in what would be outline in a future data sharing agreement), we have not yet finalized decisions on types of supporting information that will be shared, IPD Sharing Time Frame, IPD Sharing Access Criteria for other future data sharing agreements.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Vaping Characterization and Parent Views on Adolescent Vaping Protocol
- ClinicalTrials.gov ID
- NCT05669716
- Acronym / sponsor ID
- 10001196
- Conditions
- Healthy Volunteers, Vaping Teens
- Keywords
- Vape, Nicotine, Teen, Drug Use, Natural History
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator is leaving NIDA.
- Enrolment
- 726 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 3 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
The use of electronic cigarettes (vaping) has increased among adolescents over the past decade. Vaping raises many health concerns. People who vape inhale toxic chemicals. Vaping is also linked with mental health issues, such as depression and suicide risk. In one survey, 85% of young adults reported that they used both vaping and tobacco products; the primary reason they cited for using these products was stress.
Objective:
This natural history study will survey adolescents and their parents about their attitudes toward vaping.
Eligibility:
People aged 13 to 18, including those who vape; those who once vaped; and those who have never vaped. Parents of people aged 13 to 18 who are known or suspected of vaping are also needed.
Design:
Participants will take a survey. They will use their own smartphone, computer, or tablet to answer questions. The survey will take about 20 minutes. Their answers will be anonymous.
Teenage participants will answer questions on different topics:
Vaping habits, such as when and how they vape.
Drug use, including nicotine, cannabis, and alcohol.
Mood issues, such as depression, anxiety, and stress.
Social influences on vaping, including perceived attitudes of parents and peers.
Other leisure habits, including online gaming and use of social media.
Parents will answer similar questions.
A phone number and links will be given to participants who need help for suicidal thoughts. Other links will be given to those who want help with parenting resources or aids to quit vaping.
Participants may be invited to take part in an 8-week course on mindfulness-based stress reduction.
Participants who finish the survey will receive 10 dollars.
...
Detailed description
Study Description: This protocol will explore characteristics of adolescents who vape and the attitudes of adolescents and parents of adolescents who vape towards adolescent vaping, focusing on the Baltimore area. Hypotheses: (Adolescent) Currently vaping adolescents will not view vaping as a problem for which they seek help and will have more mental health symptoms than non-vaping adolescents, while non-vaping adolescents will view vaping more negatively with formerly vaping adolescents scoring between the currently vaping and non-vaping adolescent groups. (Parent) Parents who vape will be more likely to approve of their adolescent s vaping than non-vaping parents.
Objectives:
Primary Objective: To characterize adolescent vaping patterns, overall drug use, perceived stress, and awareness of mindfulness meditation.
Secondary Objectives: To characterize the mental health symptoms of currently vaping, formerly vaping and non-vaping adolescents, and to characterize parent attitudes towards their adolescent s vaping.
Endpoints:
Primary Endpoint: An adequate description of adolescent vapers habits and attitudes towards their vaping.
Secondary Endpoints: An adequate comparison of adolescent vapers, former vapers and non-vapers and of parental attitudes towards adolescent vapers.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| parents of teens who vape | – | –400 parent participants, defined as an adult who identifies as parenting an adolescent aged 13-17 whom they know/suspect is vaping. |
| teens who formerly vaped | – | –Adolescents N=400 (formerly vaped) |
| teens who never vaped | – | –Adolescents N=400 (never vaped). |
| teens who vape | – | –adolescent participants (minor subjects), comprised of N=400 (currently vaping, defined as vaping at least one day in the previous 30-day period |
Who may qualify
- Ages
- 13 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adolescent and parent participants will be enrolled in the survey through the internet, via their own smartphone/computer/tablet device.
Key inclusion criteria (2 listed)
- Be an adolescent age 13-18 and in grades 8-12 or the summer after graduation, OR an adult who identifies as parenting an adolescent aged 13-18 and in grades 8-12 or the summer after graduation whom they know/suspect is vaping or never has vaped. All participants must be willing to complete the survey to the end.
Key exclusion criteria (2 listed)
- Non-English speakers cannot participate in this study. Justification: The questionnaires from which the survey is constructed are not all validated in languages other than English. We do not have the resources to translate the consent and surveys.
- Those who cannot demonstrate understanding of the purpose of the survey by answering questions after a brief explanation will be excluded. Justification: The ability to understand the purpose of the survey is required in order to provide informed consent to participate and to be able to provide meaningful answers to the survey questions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Attitude toward vaping
Time frame: at time of survey
An adequate description of adolescent vapers habits and attitudes towards their vaping.
2 secondary outcomes
characteristics of parents of teens who vape
Time frame: at time of survey
comparison of vaping and non-vaping teens on mental health and other drug use
Time frame: at time of survey
Results and safety
The study was stopped early (reason given: Principal Investigator is leaving NIDA.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No. We plan to share data as specified in the protocol and potentially through future data transfer agreement(s). Any shared data will be stripped of identifiers prior to release for sharing. Deidentified data may be shared with properly administered databases and/or with collaborators with whom proper data sharing agreements are in place. Outside of the data sharing plan already specified in the protocol (in what would be outline in a future data sharing agreement), we have not yet finalized decisions on types of supporting information that will be shared, IPD Sharing Time Frame, IPD Sharing Access Criteria for other future data sharing agreements.
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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.
Betty Jo Salmeron, M.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers and Vaping Teens, run by National Institute on Drug Abuse (NIDA) 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 2 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: stopped early, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator is leaving NIDA.). Results are not available in the source record.
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?
Attitude toward vaping (time frame: at time of survey). 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 23 Dec 2025.