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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 25, 2007 | ||||
| Last Updated Date | March 25, 2009 | ||||
| Start Date ICMJE | June 2007 | ||||
| Estimated Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Relationship between cigarette smoking and panic vulnerability [ Time Frame: Measured at completion of laboratory testing analysis ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Relationship between cigarette smoking and panic vulnerability [ Time Frame: Measured at completion of laboratory testing analysis ] | ||||
| Change History | Complete list of historical versions of study NCT00535964 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluating the Relationship Between Tobacco Use, Anxiety Sensitivity, and Panic in Adolescents | ||||
| Official Title ICMJE | Anxiety Sensitivity, Tobacco Use, and Panic Among Adolescents | ||||
| Brief Summary | This study will determine whether there is a relationship between tobacco use and a heightened response to panic-producing events among adolescents. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Prospective | ||||
| Condition ICMJE | Panic Disorder | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | Psychologically healthy adolescents, evenly divided across the various stages of smoking uptake | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 180 | ||||
| Estimated Completion Date | April 2009 | ||||
| Estimated Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Years to 17 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00535964 | ||||
| Responsible Party | Ellen W. Leen-Feldner, University of Arkansas | ||||
| Study ID Numbers ICMJE | R03 MH077692, DAHBR 96-BHB | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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