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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00511134
Recruitment Status : Terminated (Study has been terminated due low recruitment of participant population.)
First Posted : August 3, 2007
Results First Posted : December 4, 2009
Last Update Posted : March 13, 2012
Information provided by (Responsible Party):
Andrea H. Weinberger, Yale University

Brief Summary:


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.


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 asleep, higher sleep quality, and less insomnia-related fatigue and distress than participants taking placebo.

Condition or disease Intervention/treatment Phase
Insomnia Nicotine Dependence Drug: Eszopiclone Drug: Bupropion Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Randomized Trial of Eszopiclone for the Treatment of Bupropion- and Abstinence-Related Insomnia During Smoking Cessation
Study Start Date : April 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Zyban + Lunesta
Zyban (150 mg qd x 7 days then 150 mg bid x 6 weeks) + Lunesta (3 mg qd x 6 weeks)
Drug: Eszopiclone
eszopiclone (lunesta) - 3 mg qd x 6 weeks, oral capsule
Other Name: Lunesta

Drug: Bupropion
bupropion SR in oral capsule will be begun at the beginning of week 1 (150 mg qd x 7 days) with an increase to the full dose (150 mg bid x 6 weeks) at the beginning of week 2.
Other Name: Zyban

Placebo Comparator: Zyban + Placebo
Zyban (150 mg qd x 7 days then 150 mg bid x 6 weeks) + placebo (1 pill per day x 6 weeks)
Drug: Bupropion
bupropion SR in oral capsule will be begun at the beginning of week 1 (150 mg qd x 7 days) with an increase to the full dose (150 mg bid x 6 weeks) at the beginning of week 2.
Other Name: Zyban

Primary Outcome Measures :
  1. Level of Insomnia as Measured by the Insomnia Severity Index [ Time Frame: 6 weeks after target smoking quit date ]
    Insomnia Severity Index (ISI): 13-item self-report measure which examines symptoms of insomnia, consequences of insomnia, and subjective distress related to sleep problems. Subjects rate the symptoms and consequences of insomnia on a 5 point Likert scales. For example, subjects are asked to rate the severity of their insomnia (e.g., difficulty falling asleep from 0=none to 4=very severe). Scores on the first 7 items are summed for a total insomnia score ranging from 0-28.

Secondary Outcome Measures :
  1. Smoking Abstinence as Measured by Self Reported Smoking and Confirmed by CO Level [ Time Frame: 6 weeks after target smoking quite date ]
    Endpoint abstinence will be defined as 0 cigarettes over the seven days prior to the subject's Timeline Follow-Back evaluation at the end of week 7 (end of trial) and a Carbon Monoxide (CO) level ≤ 5.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 prescription 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00511134

United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Principal Investigator: Andrea H. Weinberger, Ph.D. Yale University

Responsible Party: Andrea H. Weinberger, Assistant Professor, Yale University Identifier: NCT00511134     History of Changes
Other Study ID Numbers: 0609001866
First Posted: August 3, 2007    Key Record Dates
Results First Posted: December 4, 2009
Last Update Posted: March 13, 2012
Last Verified: March 2012

Keywords provided by Andrea H. Weinberger, Yale University:
nicotine dependence
smoking cessation

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Tobacco Use Disorder
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Hypnotics and Sedatives
Central Nervous System Depressants