Impact of Smoking Cessation on Sleep - 5
Condition: Tobacco Use Cessation; Sleep Disorders
MeSH terms: Sleep Wake Disorders; Parasomnias
Study type: Interventional
Phase: Phase 4

Summary: 
      Smoking is a major health problem with a direct link to elevated heart- and lung-related
      problems. Nicotine is highly addictive, which makes quitting difficult and relapse after
      quitting highly probable. Any type of sleep disturbance may make quitting even harder. The
      purpose of this study is to evaluate the effect of bupropion and nicotine replacement
      therapies (NRT) on sleep disturbances. In turn, this might show how such medications affect
      attempts at smoking cessation.
    

Detailed description: 
      The majority of attempts to quit smoking end in failure due to unpleasant withdrawal
      symptoms. One such symptom is sleep disturbances. Bupropion, effective in assisting with
      smoking cessation, commonly causes sleep disturbances as a medication side effect. In
      addition, a number of NRTs also cause sleep disturbances. This study will aim to characterize
      the effect of smoking cessation and smoking cessation treatments on sleep by measuring
      central and autonomic nervous system arousal. The study will also evaluate the impact of
      smoking cessation treatments on daytime sleepiness and mood as well as their effect on
      smoking relapse.

      Participants will be randomly assigned to one of four groups. Participants will receive
      either bupropion (150 mg for 3 days and 300 mg for 60 days) or placebo, starting one week
      prior to smoking quit day. They will then receive either active NRT (21 mg for 6 weeks, 14 mg
      for 1 week, and 7 mg for 1 week) or placebo, starting on quit day. Participants will be
      studied for up to 5 nights in a sleep lab. Sleep studies will include polysomnography
      measurements, including electrooculography of both eyes, activity of mentalis muscle and both
      anterior tibialis muscles, EEG, ECG, oxygen saturation, airflow, and respiratory efforts.
      Sleep studies will occur on the 2 nights prior to quit day, the quit night, and the 2 nights
      after quitting. Each sleep study will be followed by daytime measures. These will include a
      series of self-report instruments, sleepiness and performance measures, and physiological
      activity measures. Carbon monoxide levels will also be a daytime measurement and must fall
      below 10 ppm on the post quit days. All participants will receive bimonthly phone counseling
      for 12 months, starting on quit day. Participants will have follow-up evaluations at Months 3
      and 12 in order to measure carbon monoxide levels and complete self-report instruments.
    

Intervention name(s): Bupropion; Transdermal Nicotine Patch; Placebo Bupropion; Placebo transdermal nicotine patch
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Days 1-3, 150 mg Bupropion in am; days 4-63, 300 mg Bupropion (150 mg in am and 150 mg in pm); 21-mg nicotine patch applied in AM for 6 weeks, starting on the morning of quit day; 14-mg patch applied in AM for 2 weeks; 7-mg patch applied in AM for 1 week; Days 1-3, 150 mg placebo Bupropion in am; days 4-63, 300 mg placebo Bupropion (150 mg in am and 150 mg in pm); 21-mg placebo nicotine patch applied in AM for 6 weeks, starting on the morning of quit day; 14-mg placebo patch applied in AM for 2 weeks; 7-mg placebo patch applied in AM for 1 week
Other intervention name(s): Zyban
Intervention MeSH terms: Bupropion; Nicotine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nicotine dependence; Sleep disorders; smoking cessation; Relapse