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

Primary Purpose

Insomnia, Nicotine Dependence

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Eszopiclone

Bupropion

About this trial

This is an interventional treatment trial for Insomnia focused on measuring insomnia, nicotine dependence, smoking, smoking cessation, zyban

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Connecticut Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zyban + Lunesta

Zyban + Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT00511134

First Posted

August 1, 2007

Last Updated

May 5, 2022

Sponsor

Yale University

Collaborators

Sumitomo Pharma America, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00511134

Brief Title

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

Official Title

A Placebo-Controlled, Randomized Trial of Eszopiclone for the Treatment of Bupropion- and Abstinence-Related Insomnia During Smoking Cessation

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Terminated

Why Stopped

Study has been terminated due low recruitment of participant population.

Study Start Date

April 2007 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia, Nicotine Dependence

Keywords

insomnia, nicotine dependence, smoking, smoking cessation, zyban

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zyban + Lunesta

Arm Type

Experimental

Arm Description

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

Arm Title

Zyban + Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Eszopiclone

Other Intervention Name(s)

Lunesta

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bupropion

Other Intervention Name(s)

Zyban

Intervention Description

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.

Primary Outcome Measure Information:

Title

Level of Insomnia as Measured by the Insomnia Severity Index

Description

Time Frame

6 weeks after target smoking quit date

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

6 weeks after target smoking quite date

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea H. Weinberger, Ph.D.

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Connecticut Mental Health Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

12. IPD Sharing Statement

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

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