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| Sponsor: | National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00132821 |
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tobacco Use Cessation Sleep Disorders |
Drug: Bupropion Drug: Transdermal Nicotine Patch Drug: Placebo Bupropion Drug: Placebo transdermal nicotine patch |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Factorial Assignment, Efficacy Study |
| Official Title: | Impact of Smoking Cessation on Sleep |
| Estimated Enrollment: | 136 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Active Comparator
Bupropion
|
Drug: Bupropion
Days 1-3, 150 mg Bupropion in am; days 4-63, 300 mg Bupropion (150 mg in am and 150 mg in pm)
|
|
B: Active Comparator
Transdermal nicotine patch
|
Drug: Transdermal Nicotine Patch
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
|
| C: Placebo Comparator |
Drug: Placebo Bupropion
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)
|
| D: Placebo Comparator |
Drug: Placebo transdermal nicotine patch
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Mary R McElroy, M.P.H. | (650)859-4130 | mary.mcelroy@sri.com |
| United States, California | |
| SRI International | Recruiting |
| Menlo Park, California, United States, 94025 | |
| Contact: Gary E Swan 650-859-5322 gary.swan@sri.com | |
| Principal Investigator: | Gary Swan | SRI International |
More Information
| Responsible Party: | SRI International ( Gary E. Swan, PI ) |
| Study ID Numbers: | NIDA-16427-5, R01-16427-5, DPMC |
| Study First Received: | August 18, 2005 |
| Last Updated: | August 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00132821 History of Changes |
| Health Authority: | United States: Federal Government |
|
Nicotine dependence Sleep disorders smoking cessation Relapse |
|
Dopamine Uptake Inhibitors Nicotine polacrilex Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Cholinergic Agonists Molecular Mechanisms of Pharmacological Action Nicotinic Agonists Physiological Effects of Drugs Psychotropic Drugs Sleep Disorders Cholinergic Agents Signs and Symptoms Pathologic Processes Nicotine Mental Disorders |
Therapeutic Uses Ganglionic Stimulants Antidepressive Agents, Second-Generation Antidepressive Agents Disease Nervous System Diseases Central Nervous System Stimulants Pharmacologic Actions Autonomic Agents Bupropion Neurologic Manifestations Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |
