Expired Study
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Menlo Park, California 94025


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

NIDA-16427-5


NCT ID:

NCT00132821


Secondary ID:

R01-16427-5


Study Acronym:


Brief Title:

Impact of Smoking Cessation on Sleep - 5


Official Title:

Impact of Smoking Cessation on Sleep


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Drug Abuse (NIDA)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

59


Enrollment Type:

Actual


Overall Contact Information

Official Name:Gary Swan
Principal Investigator
SRI International

Study Dates

Start Date:August 2005
Completion Date:May 2009
Completion Type:Actual
Primary Completion Date:May 2009
Primary Completion Type:Actual
Verification Date:June 2009
Last Changed Date:January 11, 2017
First Received Date:August 18, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Pre- and post-cessation sleep measures by in-laboratory polysomnography
Time Frame:Up to 7 days post-cessation
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Smoking cessation status confirmed by carbon monoxide levels
Time Frame:Up to 12 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Bupropion
Description:Days 1-3, 150 mg Bupropion in am; days 4-63, 300 mg Bupropion (150 mg in am and 150 mg in pm)
Arm Name:A
Other Name:Zyban
Intervention Type:Drug
Name:Transdermal Nicotine Patch
Description:21-mg nicotine patch applied in AM for 6 weeks, starting on the morning of quit day; 14-mg patch applied in AM for 2 weeks; 7-mg patch applied in AM for 1 week
Arm Name:B
Intervention Type:Drug
Name:Placebo Bupropion
Description:Days 1-3, 150 mg placebo Bupropion in am; days 4-63, 300 mg placebo Bupropion (150 mg in am and 150 mg in pm)
Arm Name:C
Intervention Type:Drug
Name:Placebo transdermal nicotine patch
Description:21-mg placebo nicotine patch applied in AM for 6 weeks, starting on the morning of quit day; 14-mg placebo patch applied in AM for 2 weeks; 7-mg placebo patch applied in AM for 1 week
Arm Name:D

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:D
Study Arm Type:Placebo Comparator
Arm Name:C
Study Arm Type:Active Comparator
Arm Name:B
Description:Transdermal nicotine patch
Study Arm Type:Active Comparator
Arm Name:A
Description:Bupropion

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Drug Abuse (NIDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Colrain IM, Trinder J, Swan GE. The impact of smoking cessation on objective and subjective markers of sleep: review, synthesis, and recommendations. Nicotine Tob Res. 2004 Dec;6(6):913-25. Review.
PMID:15801567

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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