Conditions: Insomnia Nicotine Dependence
Keywords: insomnia nicotine dependence smoking smoking cessation zyban
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4
Healthy volunteers: yes

Brief summary:
Objectives:

The primary objective of this study is to determine the efficacy of eszopiclone at treating sleep problems related to withdrawal from nicotine in healthy smokers attempting smoking cessation.

Sleep disturbances are a significant problem for smokers who are trying to quit smoking. Smokers may be more likely to have sleep problems and both nicotine withdrawal and agents used to aid smoking cessation (e.g., pharmacotherapies) may disrupt sleep. Lunesta (eszopiclone) is a medication that has been approved by the FDA to treat insomnia. Eszopiclone's efficacy for treating insomnia makes it a promising agent for treating nicotine withdrawal-related symptoms of sleep disturbance.

This study will be 7 weeks duration. All participants will begin taking Zyban at the beginning of week 1 and will be asked to try to quit smoking at the beginning of week 2. Participants will also begin to take Lunesta or matched placebo (3 mg qd x 6 weeks) on the target quit date at the beginning of week 2. All subjects will receive eight (8) weekly sessions of brief individual supportive smoking cessation counseling.

Hypothesis:

It is hypothesized that significantly fewer sleep problems will be reported by participants taking Lunesta as compared to placebo. Specifically, it is expected that participants taking Lunesta will report less difficulty falling and staying asleep, higher sleep quality, and less insomnia-related fatigue and distress than participants taking placebo.

Detailed description:

Arms:
arm 1: Zyban (150 mg qd x 7 days then 150 mg bid x 6 weeks) + Lunesta (3 mg qd x 6 weeks) arm 2: Zyban (150 mg qd x 7 days then 150 mg bid x 6 weeks) + placebo (1 pill per day x 6 weeks)

Interventions: intervention 1: Eszopiclone intervention 2: Bupropion
Intervention descriptions: intervention 1: eszopiclone (lunesta) - 3 mg qd x 6 weeks, oral capsule intervention 2: bupropion SR in oral capsule will be begun at the beginning of week 1 (150 mg qd x 7 days) with an increase to the full dose (150 mg bid x 6 weeks) at the beginning of week 2.

Protocol document: