Panic DisorderNCT00535964
Evaluating the Relationship Between Tobacco Use, Anxiety Sensitivity, and Panic in Adolescents
An observational study of Panic Disorder, run by University of Arkansas, Fayetteville at 1 site in United States.
Trial summary
This study will determine whether there is a relationship between tobacco use and a heightened response to panic-producing events among adolescents. This study is fundamental research. It was not a Clinical Trial. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Panic Disorder
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Apr 2009
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants will be 180 psychologically healthy adolescents, evenly divided across the various stages of smoking uptake (i.e., non-smokers, tried smoking, experimenters, regular smokers, and daily smokers).
Who may be able to join
- Adolescents, ranging from those who have never smoked to those who smoke daily
Who cannot join
- Current or past diagnosis of a panic disorder
- Acute or chronic cardiopulmonary or respiratory illness (e.g., asthma or bronchitis)
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas
Fayetteville, Arkansas, 72701
About this study
Official title: Anxiety Sensitivity, Tobacco Use, and Panic Among Adolescents
This study will determine whether there is a relationship between tobacco use and a heightened response to panic-producing events among adolescents. This study is fundamental research. It was not a Clinical Trial.
Read the detailed description
Growing up is hard enough, and adolescence can be a particularly stressful time in people's lives as they adjust to the transition from childhood to adulthood. Peer pressure can add to this anxiety, making it more likely for teens to take part in risky behaviors such as smoking cigarettes. Every day, more than 4,000 teens smoke their first cigarette and nearly half of those teens will become regular, daily smokers. Cigarette smoking is associated with a multitude of health risks, including an increased likelihood of experiencing panic attacks, anxiety disorders, and depression. This study will evaluate a group of teens, ranging from those who have never smoked to those who smoke daily, to determine whether there is a relation between adolescent smoking history and their vulnerability to panic-producing situations.
Participants in this study will undergo a brief medical screening, followed by a short interview that will include several questionnaires regarding emotions, experiences, and personal habits. Participants will then attend a series of laboratory assessments for 1 hour. The first assessment will include a 3-minute voluntary hyperventilation procedure in which participants will be directed when to breathe in and when to breathe out, at a faster rate than normal. Participants will then take part in two computerized tasks: one will be a computerized task that involves blowing up a balloon and deciding when to quit before the balloon pops; the other task will involve choosing hypothetical amounts of money now or after a period of delay. During the laboratory assessments, all participants will have electrodes attached to their bodies and sensors around their chests to measure heart rate, palm sweating, and muscle tension. Results from this study will be used to evaluate the association between smoking and increased panic levels under stressful conditions among adolescents.
- Conditions
- Panic Disorder
- Keywords
- Cigarette Smoking, Tobacco Use, Adolescents, Anxiety Sensitivity (AS)
- Medical subject headings
- Panic Disorder, Cigarette Smoking, Tobacco Use
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 |
|---|---|---|
| 1 | Psychologically healthy adolescents, evenly divided across the various stages of smoking uptake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between cigarette smoking and panic vulnerability
Measured: Measured at completion of laboratory testing analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study startJun 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic DisorderStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas, Fayetteville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ellen Leen-Feldner, University of Arkansas, Fayetteville
- Investigators
- Ellen W. Leen-Feldner, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535964
- Sponsor's protocol ID
- R03MH077692
- Other IDs
- R03MH077692, DAHBR 96-BHB
- Status last verified
- Nov 2022
- First submitted
- 25 Sep 2007
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety Sensitivity, Tobacco Use, and Panic Among Adolescents
- ClinicalTrials.gov ID
- NCT00535964
- Acronym / sponsor ID
- R03MH077692
- Conditions
- Panic Disorder
- Keywords
- Cigarette Smoking, Tobacco Use, Adolescents, Anxiety Sensitivity (AS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of Arkansas, FayettevilleUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 27 Sep 2007 (estimated)
- 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.
This study will determine whether there is a relationship between tobacco use and a heightened response to panic-producing events among adolescents. This study is fundamental research. It was not a Clinical Trial.
Detailed description
Growing up is hard enough, and adolescence can be a particularly stressful time in people's lives as they adjust to the transition from childhood to adulthood. Peer pressure can add to this anxiety, making it more likely for teens to take part in risky behaviors such as smoking cigarettes. Every day, more than 4,000 teens smoke their first cigarette and nearly half of those teens will become regular, daily smokers. Cigarette smoking is associated with a multitude of health risks, including an increased likelihood of experiencing panic attacks, anxiety disorders, and depression. This study will evaluate a group of teens, ranging from those who have never smoked to those who smoke daily, to determine whether there is a relation between adolescent smoking history and their vulnerability to panic-producing situations.
Participants in this study will undergo a brief medical screening, followed by a short interview that will include several questionnaires regarding emotions, experiences, and personal habits. Participants will then attend a series of laboratory assessments for 1 hour. The first assessment will include a 3-minute voluntary hyperventilation procedure in which participants will be directed when to breathe in and when to breathe out, at a faster rate than normal. Participants will then take part in two computerized tasks: one will be a computerized task that involves blowing up a balloon and deciding when to quit before the balloon pops; the other task will involve choosing hypothetical amounts of money now or after a period of delay. During the laboratory assessments, all participants will have electrodes attached to their bodies and sensors around their chests to measure heart rate, palm sweating, and muscle tension. Results from this study will be used to evaluate the association between smoking and increased panic levels under stressful conditions among adolescents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Psychologically healthy adolescents, evenly divided across the various stages of smoking uptake |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants will be 180 psychologically healthy adolescents, evenly divided across the various stages of smoking uptake (i.e., non-smokers, tried smoking, experimenters, regular smokers, and daily smokers).
Key inclusion criteria (1 listed)
- Adolescents, ranging from those who have never smoked to those who smoke daily
Key exclusion criteria (3 listed)
- Current or past diagnosis of a panic disorder
- Acute or chronic cardiopulmonary or respiratory illness (e.g., asthma or bronchitis)
- Pregnant
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
Relationship between cigarette smoking and panic vulnerability
Time frame: Measured at completion of laboratory testing analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
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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.
Ellen W. Leen-Feldner, PhD principal investigator
University of Arkansas
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 Panic Disorder, run by University of Arkansas, Fayetteville 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 1 inclusion and 3 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 17 Nov 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relationship between cigarette smoking and panic vulnerability (time frame: Measured at completion of laboratory testing analysis). 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 17 Nov 2022.