Effectiveness of Various Smoking Cessation Therapies in Reducing Smoking in Adolescents - 1
Condition: Smoking Cessation; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

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 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.
    

Intervention name(s): Nicotine Replacement Therapies; Nicotine patch; Folic Acid
Intervention type(s): Drug; Drug; Dietary Supplement
Intervention description(s): Nicotine gum 2 & 4 mg dependent on baseline smoking rate; 21, 14 or 7 mg patch dependent on baseline smoking rate; 400 mg
Other intervention name(s): Nicorette; Nicoderm
Intervention MeSH terms: Folic Acid; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking addiction