Study of Lunesta Versus Placebo for Sleep Problems Related to Smoking Cessation and Zyban
Condition: Insomnia; Nicotine Dependence
MeSH terms: Sleep Initiation and Maintenance Disorders; Tobacco Use Disorder
Intervention: Eszopiclone; Bupropion
Intervention description: eszopiclone (lunesta) - 3 mg qd x 6 weeks, oral capsule; 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.
Intervention MeSH terms: Eszopiclone; Bupropion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: insomnia; nicotine dependence; smoking; smoking cessation; zyban

Summary:

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

Eligibility 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 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).