Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511134
Status:
TERMINATED
Last Update Posted:
2022-05-09
First Post:
2007-08-01
Brief Title:
Study of Lunesta Versus Placebo for Sleep Problems Related to Smoking Cessation and Zyban
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
A Placebo-Controlled Randomized Trial of Eszopiclone for the Treatment of Bupropion- and Abstinence-Related Insomnia During Smoking Cessation
Status:
TERMINATED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study has been terminated due low recruitment of participant population
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg pharmacotherapies may disrupt sleep Lunesta eszopiclone is a medication that has been approved by the FDA to treat insomnia Eszopiclones 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
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 eg pharmacotherapies may disrupt sleep Lunesta eszopiclone is a medication that has been approved by the FDA to treat insomnia Eszopiclones 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ESRC099 | None | None | None |