Study of Lunesta Versus Placebo for Sleep Problems Related to Smoking Cessation and Zyban
Status:
Terminated
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
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.