Impact of Smoking Cessation on Sleep - 5

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00132821
First received: August 18, 2005
Last updated: August 5, 2008
Last verified: August 2008
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Smoking Cessation on Sleep

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Pre- and post-cessation sleep measures by in-laboratory polysomnography [ Time Frame: Up to 7 days post-cessation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Smoking cessation status confirmed by carbon monoxide levels [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

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
Active Comparator: A
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)
Other Name: Zyban
Active Comparator: B
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
Placebo Comparator: C 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)
Placebo Comparator: D 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132821

Contacts
Contact: Mary R McElroy, M.P.H. (650)859-4130 mary.mcelroy@sri.com

Locations
United States, California
SRI International Recruiting
Menlo Park, California, United States, 94025
Contact: Gary E Swan    650-859-5322    gary.swan@sri.com   
Sponsors and Collaborators
Investigators
Principal Investigator: Gary Swan SRI International
  More Information

Publications:
Responsible Party: Gary E. Swan, PI, SRI International
ClinicalTrials.gov Identifier: NCT00132821     History of Changes
Other Study ID Numbers: NIDA-16427-5, R01-16427-5, DPMC
Study First Received: August 18, 2005
Last Updated: August 5, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Nicotine dependence
Sleep disorders
smoking cessation
Relapse

Additional relevant MeSH terms:
Sleep Disorders
Nervous System Diseases
Mental Disorders
Parasomnias
Neurologic Manifestations
Signs and Symptoms
Nicotine
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014