Smoking Cessation Clinical Trial
Official title:
Interventions for Tobacco Dependent Adolescents
Currently one in five high school students smoke. Smoking can harm adolescents well before they reach adulthood by causing a number of immediate, sometimes irreversible, health risks and problems. This study will examine whether reducing smoking will facilitate quitting smoking in adolescents who have unsuccessfully attempted to quit smoking
Status | Completed |
Enrollment | 200 |
Est. completion date | September 2007 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 19 Years |
Eligibility |
Inclusion Criteria: - Has smoked at least 5 cigarettes a day for at least 6 months - Does not regularly use other tobacco products - Motivated to quit smoking - Not currently using medications to quit smoking - Willing to use an effective form of contraception throughout the study Exclusion Criteria: - Informed that nicotine replacement therapy is medically inadvisable - Diagnosed with a psychiatric disorder within 3 months prior to enrollment - Currently taking an unstable dose of psychoactive medications - Currently taking medications that may react with a nicotine patch - History of alcohol or drug abuse within 3 months prior to enrollment - Pregnant |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quit Rate; measured throughout study | 26 weeks | No | |
Primary | Extent of reduction in smoking; measured at Week 6 | 6, 12 and 26 weeks | No | |
Secondary | Degree of motivation to quit; measured at Week 6 | 6, 12 and 26 weeks | No | |
Secondary | Extent of exposure to cigarette toxicity; measured throughout study | 6, 12 and 26 weeks | No |
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