Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-19 @ 3:59 AM
Study NCT ID:
NCT05484505
Status:
UNKNOWN
Last Update Posted:
2023-03-24
First Post:
2022-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preloaded Combination Nicotine Replacement Therapy on Smoking Cessation of Adult Population in Kazakhstan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D003419', 'term': 'Crisis Intervention'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-22', 'studyFirstSubmitDate': '2022-07-22', 'studyFirstSubmitQcDate': '2022-07-30', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pattern of smoking', 'timeFrame': 'Assessed at 12 months from the starting point of intervention.', 'description': 'The change in smoking frequency from the baseline information (It can be excess use, reduced use or relapse)'}], 'primaryOutcomes': [{'measure': 'Self reported smoking during intervention period : Yes/No', 'timeFrame': 'Assessed at 12 months from the starting point of intervention.', 'description': 'Self-reported smoking anytime during the intervention or follow-up period'}, {'measure': 'Salivary cotinine test results: Positive or Negative', 'timeFrame': 'Salivary cotinine test results before intervention, after the intervention and after follow ups', 'description': 'Salivary cotinine test results before, during and after the intervention'}], 'secondaryOutcomes': [{'measure': 'Self reported number of quit attempts of tobacco', 'timeFrame': 'Assessed at 3, 6 & 12 months from the starting point of intervention.', 'description': 'Number of quit attempts of tobacco since enrolment'}, {'measure': 'Self reported number of smoked cigarettes/bidis per day', 'timeFrame': 'Assessed at 12 months from the starting point of intervention.', 'description': 'Number of smoked cigarettes/bidis per day since enrolment'}, {'measure': 'Adherence to intervention in days: Self reported', 'timeFrame': 'Assessed at 12 months from the starting point of intervention.', 'description': 'Self reported duration of use of the intervention in days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tobacco', 'Smoking', 'Nicotine Patches', 'Nicotine Gums', 'Nicotine Replacement Therapy', 'Preloading'], 'conditions': ['Smoking Cessation', 'Smoking, Cigarette', 'Smoking Behaviors']}, 'referencesModule': {'references': [{'pmid': '20884658', 'type': 'RESULT', 'citation': 'Hays JT, Croghan IT, Baker CL, Cappelleri JC, Bushmakin AG. Changes in health-related quality of life with smoking cessation treatment. Eur J Public Health. 2012 Apr;22(2):224-9. doi: 10.1093/eurpub/ckq137. Epub 2010 Sep 30.'}, {'pmid': '30932386', 'type': 'RESULT', 'citation': 'Wang Q, Mati K. Intention to Quit among Smokers in Kazakhstan: Data from 2014 Global Adult Tobacco Survey. J Epidemiol Glob Health. 2019 Mar;9(1):23-28. doi: 10.2991/jegh.k.190212.002.'}, {'pmid': '31241286', 'type': 'RESULT', 'citation': 'Levy DT, Levy J, Mauer-Stender K. Potential impact of strong tobacco-control policies in 11 newly independent states. Cent Eur J Public Health. 2019 Jun;27(2):115-126. doi: 10.21101/cejph.a5506.'}, {'pmid': '32578165', 'type': 'RESULT', 'citation': 'Giulietti F, Filipponi A, Rosettani G, Giordano P, Iacoacci C, Spannella F, Sarzani R. Pharmacological Approach to Smoking Cessation: An Updated Review for Daily Clinical Practice. High Blood Press Cardiovasc Prev. 2020 Oct;27(5):349-362. doi: 10.1007/s40292-020-00396-9. Epub 2020 Jun 23.'}, {'pmid': '11717401', 'type': 'RESULT', 'citation': 'Llimargas M, Lawrence PA. Seven Wnt homologues in Drosophila: a case study of the developing tracheae. Proc Natl Acad Sci U S A. 2001 Dec 4;98(25):14487-92. doi: 10.1073/pnas.251304398. Epub 2001 Nov 20.'}, {'pmid': '26284723', 'type': 'RESULT', 'citation': 'Prochaska JJ. Nicotine Replacement Therapy as a Maintenance Treatment. JAMA. 2015 Aug 18;314(7):718-9. doi: 10.1001/jama.2015.7460.'}, {'pmid': '29486753', 'type': 'RESULT', 'citation': 'Chai W, Zou G, Shi J, Chen W, Gong X, Wei X, Ling L. Evaluation of the effectiveness of a WHO-5A model based comprehensive tobacco control program among migrant workers in Guangdong, China: a pilot study. BMC Public Health. 2018 Feb 27;18(1):296. doi: 10.1186/s12889-018-5182-6.'}, {'pmid': '22320954', 'type': 'RESULT', 'citation': 'Dhavan P, Bassi S, Stigler MH, Arora M, Gupta VK, Perry CL, Ramakrishnan L, Reddy KS. Using salivary cotinine to validate self-reports of tobacco use by Indian youth living in low-income neighborhoods. Asian Pac J Cancer Prev. 2011;12(10):2551-4.'}, {'pmid': '9725117', 'type': 'RESULT', 'citation': 'Rose JE, Behm FM, Westman EC. Nicotine-mecamylamine treatment for smoking cessation: the role of pre-cessation therapy. Exp Clin Psychopharmacol. 1998 Aug;6(3):331-43. doi: 10.1037//1064-1297.6.3.331.'}, {'pmid': '9583654', 'type': 'RESULT', 'citation': 'Hymowitz N, Cummings KM, Hyland A, Lynn WR, Pechacek TF, Hartwell TD. Predictors of smoking cessation in a cohort of adult smokers followed for five years. Tob Control. 1997;6 Suppl 2(Suppl 2):S57-62. doi: 10.1136/tc.6.suppl_2.s57.'}, {'pmid': '38011129', 'type': 'DERIVED', 'citation': 'Purushothama C, Crape BL, Stolyarov V, Jaxybayeva A, la Fleur P, Olickal JJ. Preloaded combination nicotine replacement therapy for smoking cessation in Kazakhstan: A randomized controlled trial study protocol. PLoS One. 2023 Nov 27;18(11):e0292490. doi: 10.1371/journal.pone.0292490. eCollection 2023.'}], 'seeAlsoLinks': [{'url': 'https://www.jioh.org/text.asp?2018/10/2/71/230862', 'label': 'Carbon monoxide breath analyzers and its role in tobacco cessation: A narrative review of literature.'}]}, 'descriptionModule': {'briefSummary': 'Randomized, controlled, two-armed, single-blinded, superiority trial with 1:1 allocation ratio Nicotine Replacement Therapy(NRT)', 'detailedDescription': "The primary objective is to determine the effectiveness of preloaded combination nicotine replacement therapy (NRT) on smoking cessation of tobacco smokers. The secondary objectives are to determine the predictors of smoking cessation among the study participant's, to determine the change in health-related quality of life due to smoking cessation \\& to determine the perception of treatment adherence among the study participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all current smokers aged 18 years and above with a motivation to quit\n\nExclusion Criteria:\n\n* smokeless tobacco users, smoking frequency of fewer than 10 cigarettes per day, pregnant women, lactating women, patients with a recent history of myocardial infarction of fewer than 3 months, and electronic cigarette users'}, 'identificationModule': {'nctId': 'NCT05484505', 'briefTitle': 'Preloaded Combination Nicotine Replacement Therapy on Smoking Cessation of Adult Population in Kazakhstan', 'organization': {'class': 'OTHER', 'fullName': 'Nazarbayev University'}, 'officialTitle': 'Effectiveness of Preloaded Combination Nicotine Replacement Therapy on Smoking Cessation of Adult Population in Kazakhstan- A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '11022021CRP1514'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nicotine replacement therapy (NRT) Preloading', 'description': "1. Brief Advice (5 A's \\& 5 R's)- 0-day, Month- 1, 3, 6, 9, 12\n2. a. Nicotine Replacement Therapy for \\> 20 cigarettes per day\n\nNicotine Patch: Preloading for 4 weeks + 12 weeks post quit date,21 mg: 4 weeks before and after quit date,14 mg: Next 4 weeks,7 mg: Last 4 weeks Nicotine chewing gums 4 mg for 12 weeks post quit date (12/day on week 1(Tapering dose weekly)1/day on week 12\n\n2.b. Nicotine Replacement Therapy for \\< 20 cigarettes per day Nicotine Patch: Preloading for 4 weeks + 12 weeks post quit date 21 mg: 4 weeks before and after quit date 14 mg: Next 4 weeks 7 mg: Last 4 weeks\n\nNicotine chewing gums 2 mg for 12 weeks post quit date (12/day on week\n\n1(Tapering dose)1/day on week 12", 'interventionNames': ['Drug: Nicotine patch, Nicotine gums', "Behavioral: Brief Advice (5 A's & 5 R's)", 'Drug: Nicotine Patch: Preloading for 4 weeks']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nicotine replacement therapy (NRT)', 'description': "1. Brief Advice (5 A's \\& 5 R's)- 0-day, Month- 1, 3, 6, 9, 12\n2. a. Nicotine Replacement Therapy for \\> 20 cigarettes per day\n\nNicotine Patch: 12 weeks post quit date 21 mg: 4 weeks after quit date 14 mg: Next 4 weeks 7 mg: Last 4 weeks\n\nNicotine chewing gums 4 mg for 12 weeks post quit date (12/day on week 1(Tapering dose weekly)1/day on week 12\n\n2.b. Nicotine Replacement Therapy for \\< 20 cigarettes per day\n\nNicotine Patch: 12 weeks post quit date 21 mg: 4 weeks after quit date 14 mg: Next 4 weeks 7 mg: Last 4 weeks\n\nNicotine chewing gums 2 mg for 12 weeks post quit date (12/day on week 1(Tapering dose)1/day on week 12", 'interventionNames': ['Drug: Nicotine patch, Nicotine gums', "Behavioral: Brief Advice (5 A's & 5 R's)"]}], 'interventions': [{'name': 'Nicotine patch, Nicotine gums', 'type': 'DRUG', 'otherNames': ['Nicotex'], 'description': 'Nicotine patch 21mg, 12 weeks post quit date and nicotine chewing gums 4mg for 12 weeks post quit date\n\n* 14 mg: Next 4 weeks\n* 7 mg: Last 4 weeks', 'armGroupLabels': ['Nicotine replacement therapy (NRT)', 'Nicotine replacement therapy (NRT) Preloading']}, {'name': "Brief Advice (5 A's & 5 R's)", 'type': 'BEHAVIORAL', 'description': "Brief Advice (5 A's \\& 5 R's) at Day 0, 1 month, 3,6,9 \\& 12 months", 'armGroupLabels': ['Nicotine replacement therapy (NRT)', 'Nicotine replacement therapy (NRT) Preloading']}, {'name': 'Nicotine Patch: Preloading for 4 weeks', 'type': 'DRUG', 'description': 'Nicotine Patch: Preloading for 4 weeks - 21 mg: 4 weeks before quit date', 'armGroupLabels': ['Nicotine replacement therapy (NRT) Preloading']}]}, 'contactsLocationsModule': {'locations': [{'zip': '010000', 'city': 'Astana', 'country': 'Kazakhstan', 'contacts': [{'name': 'Chetan Purushothama', 'role': 'CONTACT'}], 'facility': 'National Research Cardiac Surgery Center, Astana, Kazakhstan', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}, {'zip': '010000', 'city': 'Astana', 'country': 'Kazakhstan', 'facility': 'Nazarbayev University School of Medicine', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be available from the corresponding author on reasonable request.', 'ipdSharing': 'YES', 'description': 'The data of the current study will available from the corresponding author on reasonable request.', 'accessCriteria': 'Data will be available from the corresponding author on reasonable request via e-mail'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nazarbayev University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Astana Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Chethan Purushothama', 'investigatorAffiliation': 'Nazarbayev University'}}}}