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 unsuccesfully attempted to quit smoking

Condition	Intervention	Phase
Smoking cessation Tobacco Use Disorder	Behavior: Behavior Therapy	Phase II Phase III

Further Study Details: 

Primary Outcomes: Quit Rate; measured throughout study; Extent of reduction in smoking; measured at Week 6
Secondary Outcomes: Degree of motivation to quit; measured at Week 6; Extent of exposure to cigarette toxicity; measured throughout study

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, including several types of cancer. This study will examine whether reducing smoking will facilitate smoking cessation in adolescents who have unsuccessfully attempted to quit smoking. The study will also assess whether reduction of smoking leads to continued involvement in treatment, less toxic cigarette exposure, and improved motivation and self-efficacy to quit.

Participants in this open-label study will undergo 2 weeks of baseline measurements, followed by 2 weeks of smoking cessation treatment. Treatment will involve a nicotine patch, for those who are eligible, and a standardized behavioral intervention aimed at supporting smoking cessation. Those who are ineligible to receive a nicotine patch will only receive the standardized behavioral intervention. Participants who quit smoking during the first phase of treatment will continue to receive the nicotine patches and/or the standardized behavioral intervention. Those who are still smoking after the first treatment will be randomly assigned to one of two conditions and will continue to use nicotine patches for 4 weeks. Group 1 will receive standardized behavioral therapy and will set a specific quit date. Group 2 will be encouraged to decrease smoking by 50% the first week and 75% the second week. During Week 3, participants will be encouraged to completely quit smoking. Study visits will occur weekly, at which time nicotine patches will be dispensed, standardized behavioral therapy will be provided, and standard physiological measurements will be taken. A urine sample will also be collected. Follow-up visits will be held 2 weeks, 3 weeks, and 6 months following completion of the study.

Ages Eligible for Study:  13 Years   -   19 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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 nictoine patch
• History of alcohol or drug abuse within 3 months prior to enrollment
• Pregnant

Please refer to this study by ClinicalTrials.gov identifier  NCT00158158

Joni Jensen, M.P.H.      (612)627-4903    jense010@umn.edu

Minnesota
      University of Minnesota, Minneapolis,  Minnesota,  55455,  United States; Recruiting

Study chairs or principal investigators

Dorothy Hatsukami, Ph.D.,  Principal Investigator,  University of Minnesota   

Study ID Numbers:  NIDA-14538-2; R01-14538-2
Last Updated:  September 10, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00158158
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13