Study of Lunesta Versus Placebo for Sleep Problems Related to Smoking Cessation and Zyban - Full Text View

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

Condition	Intervention	Phase
Insomnia Nicotine Dependence	Drug: Eszopiclone Drug: Bupropion	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Sleep Disorders Smoking

Drug Information available for: Bupropion hydrochloride Bupropion Eszopiclone

U.S. FDA Resources

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 ]
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:

Smoking Abstinence as Measured by Self Reported Smoking and Confirmed by CO Level [ Time Frame: 6 weeks after target smoking quite date ] [ Designated as safety issue: No ]
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.

Enrollment:	4
Study Start Date:	April 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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 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).

Contacts and Locations

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

Locations

United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

Yale University

Sunovion

Investigators

Principal Investigator:

Andrea H. Weinberger, Ph.D.

Yale University

More Information

No publications provided

Responsible Party:	Andrea H. Weinberger, Assistant Professor, Yale University
ClinicalTrials.gov Identifier:	NCT00511134 History of Changes
Other Study ID Numbers:	0609001866, ESRC099
Study First Received:	August 1, 2007
Results First Received:	September 28, 2009
Last Updated:	March 9, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

insomnia
nicotine dependence
smoking
smoking cessation
zyban

Additional relevant MeSH terms:

Tobacco Use Disorder
Smoking
Sleep Initiation and Maintenance Disorders
Substance-Related Disorders
Mental Disorders
Habits
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Bupropion
Eszopiclone
Antidepressive Agents, Second-Generation

Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Hypnotics and Sedatives
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 21, 2013