Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT00511134
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).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00511134
Study Brief:
Protocol Section:
NCT00511134