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NCT00511134 · ClinicalTrials.gov registry record · Phase 4
Study of Lunesta Versus Placebo for Sleep Problems Related to Smoking Cessation and Zyban
A Phase 4 study, sponsored by Yale University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT00511134: Clinical Trial Phase 4 study, sponsored by Yale University.
NCT00511134 is a Phase 4 study that was terminated before completion, run by Yale University. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00511134, a Phase 4 study, was terminated before completion, sponsored by Yale University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Eszopiclone
- DRUG Bupropion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2007-04 |
| Est. Completion | 2008-12 |
| Phase | Phase 4 |
Why NCT00511134 stopped before completion
NCT00511134 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Eszopiclone is the first listed.
NCT00511134 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00511134 about?
NCT00511134 is a clinical study titled "Study of Lunesta Versus Placebo for Sleep Problems Related to Smoking Cessation and Zyban". 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. Smoke...
What is the current status of trial NCT00511134?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2007-04. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00511134?
The interventions under investigation include: Eszopiclone (DRUG), Bupropion (DRUG).
Who is sponsoring clinical trial NCT00511134?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00511134's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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