Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 8:59 AM
Study NCT ID:
NCT00511134
Status:
TERMINATED
Last Update Posted:
2022-05-09
First Post:
2007-08-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Lunesta Versus Placebo for Sleep Problems Related to Smoking Cessation and Zyban
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069582', 'term': 'Eszopiclone'}, {'id': 'D016642', 'term': 'Bupropion'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'andrea.weinberger@yale.edu', 'phone': '203-974-7598', 'title': 'Andrea H. Weinberger, Ph.D.', 'organization': 'Yale University'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year, 3 months', 'description': 'weekly questionnaire', 'eventGroups': [{'id': 'EG000', 'title': 'Zyban + Lunesta', 'description': 'Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Zyban + Placebo', 'description': 'Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Level of Insomnia as Measured by the Insomnia Severity Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zyban + Lunesta', 'description': 'Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)'}, {'id': 'OG001', 'title': 'Zyban + Placebo', 'description': 'Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'spread': '0', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '11'}, {'value': '5', 'spread': '0', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'It was hypothesized that the Zyban+Lunesta group would report lower ISI scores at end of trial than the Zyban+Placebo group.', 'statisticalMethod': 'Descriptive data', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks after target smoking quit date', 'description': '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.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline descriptive data was examined for the 4 participants. Outcome measures were available for 2 participants. Due to the small number of participants, statistical comparisons were not able to be performed.'}, {'type': 'SECONDARY', 'title': 'Smoking Abstinence as Measured by Self Reported Smoking and Confirmed by CO Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zyban + Lunesta', 'description': 'Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)'}, {'id': 'OG001', 'title': 'Zyban + Placebo', 'description': 'Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'It is predicted that subjects taking eszopiclone will be more likely to report abstinence at trial endpoint than those taking placebo.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Degrees of freedom=1'}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks after target smoking quite date', 'description': "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.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zyban + Lunesta', 'description': 'Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)'}, {'id': 'FG001', 'title': 'Zyban + Placebo', 'description': 'Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were recruited from the Greater New Haven area and surrounding communities through targeted television, radio, and newspaper ads, fliers, and referrals from clinicians. Recruitment occurred between July of 2007 and October of 2008. Approximately 900 phone screens and 12 in-person screens were completed during the course of the study.', 'preAssignmentDetails': 'Major reasons for exclusion at phone screen were report of no sleep problems, use of illegal substances, psychiatric or medical exclusions, and low smoking. Major reasons for exclusion during the in-person screening process included withdrawal of informed consent, alcohol or illicit drug use, and low smoking.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zyban + Lunesta', 'description': 'Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)'}, {'id': 'BG001', 'title': 'Zyban + Placebo', 'description': 'Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Study has been terminated due low recruitment of participant population.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2007-08-01', 'resultsFirstSubmitDate': '2009-09-28', 'studyFirstSubmitQcDate': '2007-08-02', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-11-03', 'studyFirstPostDateStruct': {'date': '2007-08-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of Insomnia as Measured by the Insomnia Severity Index', 'timeFrame': '6 weeks after target smoking quit date', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Smoking Abstinence as Measured by Self Reported Smoking and Confirmed by CO Level', 'timeFrame': '6 weeks after target smoking quite date', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insomnia', 'nicotine dependence', 'smoking', 'smoking cessation', 'zyban'], 'conditions': ['Insomnia', 'Nicotine Dependence']}, 'descriptionModule': {'briefSummary': "Objectives:\n\nThe 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.\n\nSleep 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.\n\nThis 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.\n\nHypothesis:\n\nIt 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are between ages 18-65 years old.\n* Meet DSM-IV criteria for nicotine dependence.\n* 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.\n* At the time of initial evaluation, are motivated to quit smoking in the next 30 days.\n* Receive a score of ≥ 10 on the Insomnia Severity Index (ISI)\n* Have the capacity to give informed consent, and are English-speaking.\n\nExclusion Criteria:\n\n* Are taking an over-the-counter or prescription medications that are known to affect sleep.\n* Are taking medications contraindicated for use with eszopiclone or bupropion including: Ketoconazole, Itraconazole, Clarithromycin, Erythromycin, Nefazodone, Troleandomycin, Ritonavir, Nelfinavir, Trazodone, and Methadone.\n* Are using any over-the-counter analgesics that contain caffeine.\n* Have serious medical disorders that may make participation in the trial unsafe.\n* 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.\n* Consume greater than 1 alcoholic beverage per day or greater than 7 alcoholic drinks per week.\n* 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.\n* 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.\n* Are from the same household as another study participant.\n* A history of seizures of any etiology.\n* A history of hypersensitivity to bupropion or Lunesta (eszopiclone).'}, 'identificationModule': {'nctId': 'NCT00511134', 'briefTitle': 'Study of Lunesta Versus Placebo for Sleep Problems Related to Smoking Cessation and Zyban', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'A Placebo-Controlled, Randomized Trial of Eszopiclone for the Treatment of Bupropion- and Abstinence-Related Insomnia During Smoking Cessation', 'orgStudyIdInfo': {'id': '0609001866'}, 'secondaryIdInfos': [{'id': 'ESRC099'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zyban + Lunesta', 'description': 'Zyban (150 mg qd x 7 days then 150 mg bid x 6 weeks) + Lunesta (3 mg qd x 6 weeks)', 'interventionNames': ['Drug: Eszopiclone', 'Drug: Bupropion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Zyban + Placebo', 'description': 'Zyban (150 mg qd x 7 days then 150 mg bid x 6 weeks) + placebo (1 pill per day x 6 weeks)', 'interventionNames': ['Drug: Bupropion']}], 'interventions': [{'name': 'Eszopiclone', 'type': 'DRUG', 'otherNames': ['Lunesta'], 'description': 'eszopiclone (lunesta) - 3 mg qd x 6 weeks, oral capsule', 'armGroupLabels': ['Zyban + Lunesta']}, {'name': 'Bupropion', 'type': 'DRUG', 'otherNames': ['Zyban'], '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.', 'armGroupLabels': ['Zyban + Lunesta', 'Zyban + Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Connecticut Mental Health Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Andrea H. Weinberger, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sumitomo Pharma America, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}