Effectiveness of Reducing Smoking in Facilitating Smoking Cessation in Adolescents - 2
|ClinicalTrials.gov Identifier: NCT00158158|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation Tobacco Use Disorder||Drug: Usual Care Other: Smoking Reduction||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Interventions for Tobacco Dependent Adolescents|
|Study Start Date :||September 2005|
|Primary Completion Date :||September 2007|
|Study Completion Date :||September 2007|
Placebo Comparator: 1
Drug: Usual Care
If unable to quit at quit date, offered usual care to set another quit date.
Other Name: Nicoderm used for initial quit attempt.
Reduction in smoking
Other: Smoking Reduction
If unable to quit smoking, reduce smoking rate prior to quit date.
Other Name: Nicotine patch used for initial cessation and smoking reduction.
- Quit Rate; measured throughout study [ Time Frame: 26 weeks ]
- Extent of reduction in smoking; measured at Week 6 [ Time Frame: 6, 12 and 26 weeks ]
- Degree of motivation to quit; measured at Week 6 [ Time Frame: 6, 12 and 26 weeks ]
- Extent of exposure to cigarette toxicity; measured throughout study [ Time Frame: 6, 12 and 26 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158158
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Dorothy Hatsukami, Ph.D.||University of Minnesota - Clinical and Translational Science Institute|