View Clinical Trial (Medical Research Study)
Stress Response and Smoking Cessation in Depressed Youth
| City: |
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Dallas |
| State: |
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Texas |
| Zip Code: |
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75390 |
| Conditions: |
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Tobacco Use Cessation - Tobacco Use Disorder |
| Purpose: |
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Little is known about the best ways to help young people stop smoking. Bupropion (a
medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers.
The purpose of this study is to determine if bupropion is also effective in treating smokers
between the ages of 12 and 25 years old. This study also compares the effectiveness of
bupropion used as a supplement to behavioral treatment versus behavioral treatment used
alone. In addition, the study evaluates whether hormonal response to stress measured prior
to the start of treatment predicts whether individuals respond well to treatment with
medication.
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| Study Summary: |
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Cigarette smoking and other forms of tobacco exposure are one of the leading preventable
causes of morbidity and mortality in the United States. Most smokers begin smoking during
adolescence, and though they seem motivated to quit smoking, they frequently fail. Although
behavioral treatments are available, they have not been very successful in past studies.
Depressed adults may have more difficulty quitting smoking than non depressed adults; this
finding may also apply to depressed youth. The purpose of this study is to determine the
effectiveness of bupropion in combination with standard behavioral treatment in helping
young smokers quit, as compared to behavioral treatment alone. Finally, the study examines
whether hormonal response to stress measured prior to treatment initiation predicts whether
individuals respond well to treatment with bupropion.
Participants in this double-blind study will be randomly assigned to receive either
bupropion or placebo. Both groups will receive behavioral treatment. The trial will last
for 9 weeks, with weekly study visits. Study visits will last 30 minutes to 1 hour and will
include medication monitoring, self-reported and biological measures of smoking, and
behavioral treatment. Participants will have follow-up visits six months after completion
of treatment and at yearly intervals for up to 4 years.
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| Criteria: |
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Inclusion Criteria:
- Has smoked at least 10 cigarettes each day for 3 or more months
- Weighs at least 90 lbs
- Motivated to quit smoking and has had at least one previous failed attempt
- Speaks, reads, and writes English
- Either diagnosed as depressed OR no history of a psychiatric disorder
Exclusion Criteria:
- History of bipolar disorder, eating disorder, schizophrenia, schizoaffective
disorder, autism, or non-nicotine substance use disorder in the 6 months prior to
study entry
- Currently suicidal or with a history of a suicide attempt in the 6 months prior to
study entry
- Psychotic symptoms
- Use of psychotropic medication(s)
- Serious medical condition
- Prior use of bupropion for smoking cessation
- Currently using other smoking cessation treatments
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| NCT ID: |
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NCT00129272 |
| Primary Contact: |
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Principal Investigator
Uma Rao, MD
University of Texas Medical Center
Kathryn Mettman
Phone: 214-648-5250
Email: kathryn.mettman@utsouthwestern.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Dallas, Texas 75390
United States
Kathryn Mettman
Phone: 214-648-5250
Email: teenhealth@utsouthwestern.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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