Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT04126135
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2019-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C004712', 'term': 'cytisine'}, {'id': 'D000095488', 'term': 'Nicotine Replacement Therapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1307}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2019-10-11', 'studyFirstSubmitQcDate': '2019-10-11', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of abstinence after 25 day course of Cytisine.', 'timeFrame': 'One month after quit date', 'description': 'Continuous abstinence is defined as \\<5 cigarettes smoked since quit date. Subjects will complete survey to determine number of cigarettes smoked since quit day.'}], 'secondaryOutcomes': [{'measure': 'Length of abstinence after 25 days of NRT', 'timeFrame': 'One month after quit date', 'description': 'Continuous abstinence is defined as \\<5 cigarettes smoked since quit date. Subjects will complete survey to determine number of cigarettes smoked since quit day.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smoking Cessation, Nicotine Replacement Therapy, Cytisine'], 'conditions': ['Nicotine Addiction']}, 'descriptionModule': {'briefSummary': 'A pragmatic, single blinded, randomized, controlled non-inferiority trial of Cytisine versus Nicotine Replacement Therapy for continuous abstinence is conducted in the government run primary health hospitals in Mongolia.', 'detailedDescription': 'Rationale: In Mongolia, smoking cessation assistance in the governmental health sector consists of behavioral counseling and a 3-week regimen of the NRT patch that costs 175 USD. This cost for low income adults limits effectiveness. A 2014 study documented the superiority and lower cost (\\<20 USD) of Cytisine versus NRT for continuous abstinence. Trial investigators are testing the comparative effectiveness of Cytisine in the "real life setting" of their national health care system and, if proven effective, will include coverage for Cytisine in the national health plan.\n\nResearch Question/Objective: To determine whether a 25 day course of Cytisine tablets is at least as effective as 25 days of NRT in helping smokers remain abstinent for at least one month.\n\nDesign: A pragmatic, single blinded, randomized, controlled non-inferiority trial.\n\nSetting: Six governmental primary care centers in Ulaanbaatar, Mongolia, and outskirts.\n\nParticipants: Mongolian adult smokers referred to government-run addiction units.\n\nIntervention and procedures: Participants are randomized to 5 weeks of treatment (n=654) or usual care (n=653) and a 6-month follow-up. The treatment consists of a 25-day course of Cytisine tablets and behavioral counseling. Usual care consists of 25 days of NRT and behavioral counseling.\n\nMeasurements: The primary outcome is continuous abstinence (\\< 5 cigarettes smoked since quit date) at 1 month. Secondary outcomes include 7-day point prevalence abstinence rates and adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Seeking smoking cessation treatment\n* Ages 18 years or older\n* Currently smoking \\> 5 cigarettes per day\n* Willingness to make quit attempt with pharmacotherapy\n* Able to provide verbal and written informed consent\n* Have telephone access\n\nExclusion Criteria:\n\n* Pregnancy or currently breastfeeding\n* Current users of NRT (patch, gum, lozenge)\n* Current users of non\\_NRT smoking cessation pharmacotherapy\n* Enrolled in another smoking cessation program (non-governmental)\n* Clinical disorder that contraindicates use of NRT or Cytisine (heart attack, stroke, severe angina within the past 2 weeks, uncontrolled hypertension, phaeochromocytoma, severe mental illness)'}, 'identificationModule': {'nctId': 'NCT04126135', 'briefTitle': 'Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy (NRT) in the National Smoking Cessation Program of Mongolia: A Pragmatic Non-Inferiority Trial', 'orgStudyIdInfo': {'id': '5170400'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care Group', 'description': 'Subjects are asked to completely stop smoking on their quit day and use a daily Nicotine Replacement Therapy (NRT) patch for 25 days.', 'interventionNames': ['Drug: Nicotine Replacement Therapy (NRT)']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Subjects will start a 25-day course of Cytisine tablets started during the four days before the quit date and are asked to reduce smoking during this time.', 'interventionNames': ['Drug: Cytisine']}], 'interventions': [{'name': 'Cytisine', 'type': 'DRUG', 'description': 'Subjects will take a 25-day course of Cytisine tablets started during the 4 days before the quit date. They will be asked to reduce smoking during this time.', 'armGroupLabels': ['Treatment Group']}, {'name': 'Nicotine Replacement Therapy (NRT)', 'type': 'DRUG', 'description': 'Subjects are asked to completely stop smoking on their quit day and use a daily NRT patch for 25 days.', 'armGroupLabels': ['Usual Care Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ulaanbaatar', 'country': 'Mongolia', 'facility': 'Mongolian National University of Medical Sciences', 'geoPoint': {'lat': 47.90771, 'lon': 106.88324}}], 'overallOfficials': [{'name': 'Pramil N Singh, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University Health'}, {'name': 'Davaalkham Dambadarjaa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mongolian National University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': 'Mongolian National University of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director and Professor, Transdisciplinary Tobacco Research Program', 'investigatorFullName': 'Pramil N Singh', 'investigatorAffiliation': 'Loma Linda University'}}}}