Effectiveness of Reducing Smoking in Facilitating Smoking Cessation in Adolescents - 2
Condition: Smoking Cessation; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): Usual Care; Smoking Reduction
Intervention type(s): Drug; Other
Intervention description(s): If unable to quit at quit date, offered usual care to set another quit date.; If unable to quit smoking, reduce smoking rate prior to quit date.
Other intervention name(s): Nicoderm used for initial quit attempt.; Nicotine patch used for initial cessation and smoking reduction.
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking addiction