Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132821
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-08-18
Brief Title:
Impact of Smoking Cessation on Sleep - 5
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Impact of Smoking Cessation on Sleep
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 |
|---|---|---|---|
| DPMC | None | None | None |
| R01-16427-5 | None | None | None |