Impact of Smoking Cessation on Sleep - 5

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.

Inclusion Criteria:

- Meets DSM-IV criteria for nicotine dependence

- History of smoking at least 20 cigarettes each day for 2 years prior to enrollment

- Expired carbon monoxide level of at least 10 ppm

- Body mass index less than 30 kg/m2

Exclusion Criteria:

- Meets DSM-IV criteria for dependence on substances other than nicotine and caffeine

- Substance abuse within the year prior to enrollment

- History of DSM-IV diagnosis of schizophrenia, bipolar disorder, obsessive compulsive
disorder, or chronic depression

- Current diagnosis of major depression

- History of neurological illness or trauma (e.g., stroke, seizure disorder, febrile
seizures, electroconvulsive therapy)

- Family history of seizure disorder

- History of head injury with loss of consciousness for longer than 1 hour

- Currently diagnosed with a sleep disorder

- Currently diagnosed with anorexia or bulimia

- Severe or chronic cardiovascular, lung, kidney, or neurological disease

- Uncontrolled hypertension or diabetes

- Use of medications contraindicated with bupropion

- High frequency alcohol use or binge drinking in the month prior to enrollment

- Pregnant or breastfeeding