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| ID | Type | Description | Link |
|---|---|---|---|
| R01-14538-1 | |||
| DPMC |
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Currently one in five high school students smokes. Smoking can harm adolescents well before they reach adulthood by causing a number of immediate, sometimes irreversible, health risks and problems. This study will compare the effectiveness of treatment with bupropion, a nicotine patch, or nicotine gum in supporting the reduction of smoking in adolescent smokers.
Among adolescents, the short-term health effects of smoking include damage to the respiratory system, addiction to nicotine, and the associated risk of other drug use. Adolescents are at greater risk for long-term health problems because most young people who smoke regularly continue to smoke throughout adulthood. This study will compare the effectiveness of treatment with bupropion, a nicotine patch, or nicotine gum in supporting the reduction of smoking in adolescent smokers. The study will also assess whether reduction of smoking leads to continued involvement in treatment, less toxic cigarette exposure, and improved motivation to quit.
This open-label study will last a total of 6 weeks. Baseline measurements will be taken twice a week at study visits for the first two weeks to assess vital signs and smoking behavior. Participants will aslo use a computerized device outside of study visits to monitor their own smoking habits. At Week 3, participants will be randomly assigned to receive bupropion, a nicotine patch, nicotine gum, or placebo. Participants will be asked to limit the frequency of their smoking to 75% of what it was during baseline. During Weeks 4, 5, and 6, participants will be expected to reduce smoking behavior to 50% of what it was at baseline. Customized doses of nicotine patches and nicotine gum, relative to the amount of cigarettes a participant smoked during baseline, will be dispensed weekly. Participants receiving bupropion or placebo will receive medication at each study visit and will take one pill daily. During treatment, study visits will occur once weekly. At each study visit, all participants will receive a 10- to 15-minute standardized behavioral therapy session aimed at supporting smoking reduction. Smoking habits and vital signs will be assessed and the effects of the treatments will be determined. There will be one follow-up visit 3 months post-intervention, at which time smoking status will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Nicotine patch |
|
| 2 | Experimental | Nicotine gum |
|
| 3 | Placebo Comparator | Folic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Replacement Therapies | Drug | Nicotine gum 2 & 4 mg dependent on baseline smoking rate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in tobacco toxicant exposure | Weeks 2, 5 and 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Motivation and self-efficacy to quit; measured at Weeks 5 and 17 | Weeks 5 and 17 | |
| Reduction in cigarettes per day | Weeks 5 and 17 | |
| Smoking cessation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dorothy Hatsukami, Ph.D. | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| D000074164 | Nicotine Chewing Gum |
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 |
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| Nicotine patch | Drug | 21, 14 or 7 mg patch dependent on baseline smoking rate |
|
|
| Folic Acid | Dietary Supplement | 400 mg |
|
| Weeks 5 and 17 |
| D001523 |
| Mental Disorders |
| Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |