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Study of Lunesta Versus Placebo for Sleep Problems Related to Smoking Cessation and Zyban

This study is currently recruiting participants.
Verified by Yale University, March 2008

Sponsors and Collaborators: Yale University
Sepracor, Inc.
Information provided by: Yale University
ClinicalTrials.gov Identifier: NCT00511134
  Purpose

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 (e.g., pharmacotherapies) may disrupt sleep. Lunesta (eszopiclone) is a medication that has been approved by the FDA to treat insomnia. Eszopiclone's 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 sleep, higher sleep quality, and less insomnia-related fatigue and distress than participants taking placebo.


Condition Intervention Phase
Insomnia
Nicotine Dependence
Drug: Lunesta
Drug: Zyban
Phase IV

MedlinePlus related topics:   Sleep Disorders    Smoking    Smoking Cessation   

ChemIDplus related topics:   Bupropion hydrochloride    Bupropion    Nicotine polacrilex    Nicotine tartrate    Eszopiclone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   A Placebo-Controlled, Randomized Trial of Eszopiclone for the Treatment of Bupropion- and Abstinence-Related Insomnia During Smoking Cessation

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Level of insomnia as measured by the Insomnia Severity Index [ Time Frame: 6 weeks after target smoking quit date ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Smoking abstinence as measured by self reported smoking [ Time Frame: 6 weeks after target smoking quite date ] [ Designated as safety issue: No ]
  • Smoking abstinence as measured by expired breath carbon monoxide (CO) level [ Time Frame: 6 weeks after target smoking quit date ] [ Designated as safety issue: No ]

Estimated Enrollment:   40
Study Start Date:   April 2007
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Zyban + Lunesta
Drug: Lunesta
3 mg capsule taken by mouth once a day immediately prior to bedtime
Drug: Zyban
150 mg capsules taken by mouth twice per day (300 mg total taken daily)
2: Placebo Comparator
Zyban + placebo
Drug: Zyban
150 mg capsules taken by mouth twice per day (300 mg total taken daily)

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Are between ages 18-65 years old.
  • Meet DSM-IV criteria for nicotine dependence.
  • Smoke at least 15 cigarettes (3/4 pack) daily (averaged over 1 week, in the past 1 month) and have an expired breath CO level >10.
  • At the time of initial evaluation, are motivated to quit smoking in the next 30 days.
  • Receive a score of ≥10 on the Insomnia Severity Index (ISI)
  • Have the capacity to give informed consent, and are English-speaking.

Exclusion Criteria:

  • Are taking an over-the-counter or prescriptions medications that are known to affect sleep.
  • Are taking medications contraindicated for use with eszopiclone or bupropion including: Ketoconazole, Itraconazole, Clarithromycin, Erythromycin, Nefazodone, Troleandomycin, Ritonavir, Nelfinavir, Trazodone, and Methadone.
  • Are using any over-the-counter analgesics that contain caffeine.
  • Have serious medical disorders that may make participation in the trial unsafe.
  • Are physiologically dependent on and/or abusing alcohol or other drugs of abuse (e.g., cocaine, opiates, benzodiazepines, etc.) in the past 6 months prior to randomization into the trial.
  • Consume greater than 1 alcoholic beverage per day or greater than 7 alcoholic drinks per week.
  • Meet DSM-IV criteria for a current diagnosis of major depressive disorder, panic disorder or post-traumatic stress disorder, or a current or past history bipolar disorder, schizophrenia, or anorexia or bulimia nervosa. Have a past history of major depression, with historical evidence of suicidal or homicidal behavior, or psychotic symptoms.
  • Have the presence of suicidal or homicidal ideation, or significant impairment of social or occupational functioning, either at study baseline during the evaluation process, or during participation in the trial
  • Are from the same household as another study participant.
  • A history of seizures of any etiology
  • A history of hypersensitivity to bupropion or Lunesta (eszopiclone).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511134

Contacts
Contact: Andrea H. Weinberger, Ph.D.     203-974-5716     andrea.weinberger@yale.edu    
Contact: Erin L. Reutenauer, B.A.     203-974-5709     erin.reutenauer@yale.edu    

Locations
United States, Connecticut
Connecticut Mental Health Center     Recruiting
      New Haven, Connecticut, United States, 06519
      Principal Investigator: Andrea H. Weinberger, Ph.D.            

Sponsors and Collaborators
Yale University
Sepracor, Inc.

Investigators
Principal Investigator:     Andrea H. Weinberger, Ph.D.     Yale University    
  More Information

Responsible Party:   Yale University School of Medicine ( Andrea Weinberger, Ph.D. )
Study ID Numbers:   0609001866, ESRC099
First Received:   August 1, 2007
Last Updated:   March 7, 2008
ClinicalTrials.gov Identifier:   NCT00511134
Health Authority:   United States: Institutional Review Board

Keywords provided by Yale University:
insomnia  
nicotine dependence  
smoking  
smoking cessation  
zyban  

Study placed in the following topic categories:
Sleep Initiation and Maintenance Disorders
Nicotine polacrilex
Tobacco Use Disorder
Sleep Disorders
Dyssomnias
Disorders of Environmental Origin
Sleep Disorders, Intrinsic
Smoking
Dopamine
Mental Disorders
Nicotine
Bupropion
Substance-Related Disorders

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions
Therapeutic Uses
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 05, 2008




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