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

NCT00511134 | Terminated Phase 4 Results

• 2 other identifiers: 0609001866ESRC099
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia; Nicotine Dependence

Keywords

insomnia; nicotine dependence; smoking; smoking cessation; zyban

Outcome Measures

Primary Outcomes (1)

• Level of Insomnia as Measured by the Insomnia Severity Index

  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.

  6 weeks after target smoking quit date

Secondary Outcomes (1)

• Smoking Abstinence as Measured by Self Reported Smoking and Confirmed by CO Level

  6 weeks after target smoking quite date

Study Arms (2)

Zyban + Lunesta

EXPERIMENTAL

Zyban (150 mg qd x 7 days then 150 mg bid x 6 weeks) + Lunesta (3 mg qd x 6 weeks)

Drug: Eszopiclone; Drug: Bupropion

Zyban + Placebo

PLACEBO COMPARATOR

Zyban (150 mg qd x 7 days then 150 mg bid x 6 weeks) + placebo (1 pill per day x 6 weeks)

Drug: Bupropion

Interventions

Eszopiclone DRUG

eszopiclone (lunesta) - 3 mg qd x 6 weeks, oral capsule

Also known as: Lunesta

Zyban + Lunesta

Bupropion DRUG

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.

Also known as: Zyban

Zyban + Lunesta; Zyban + Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yale University: lead
• Sumitomo Pharma America, Inc.: collaborator

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Tobacco Use Disorder; Smoking; Smoking Cessation

Interventions

Eszopiclone; Bupropion

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines; Propiophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Andrea H. Weinberger, Ph.D.
• Organization: Yale University

andrea.weinberger@yale.edu

203-974-7598

Study Officials

• Andrea H. Weinberger, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2007
• First Posted: August 3, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 9, 2022
• Results First Posted: December 4, 2009

Record last verified: 2022-05

Locations

US (1)