Preloaded Combination Nicotine Replacement Therapy on Smoking Cessation of Adult Population in Kazakhstan
NCT ID: NCT05484505
Last Updated: 2023-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
200 participants
INTERVENTIONAL
2023-07-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Nicotine replacement therapy (NRT) Preloading
1. Brief Advice (5 A's \& 5 R's)- 0-day, Month- 1, 3, 6, 9, 12
2. a. 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 Nicotine chewing gums 4 mg for 12 weeks post quit date (12/day on week 1(Tapering dose weekly)1/day on week 12
2.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
Nicotine chewing gums 2 mg for 12 weeks post quit date (12/day on week
1(Tapering dose)1/day on week 12
Nicotine patch, Nicotine gums
Nicotine patch 21mg, 12 weeks post quit date and nicotine chewing gums 4mg for 12 weeks post quit date
* 14 mg: Next 4 weeks
* 7 mg: Last 4 weeks
Brief Advice (5 A's & 5 R's)
Brief Advice (5 A's \& 5 R's) at Day 0, 1 month, 3,6,9 \& 12 months
Nicotine Patch: Preloading for 4 weeks
Nicotine Patch: Preloading for 4 weeks - 21 mg: 4 weeks before quit date
Nicotine replacement therapy (NRT)
1. Brief Advice (5 A's \& 5 R's)- 0-day, Month- 1, 3, 6, 9, 12
2. a. Nicotine Replacement Therapy for \> 20 cigarettes per day
Nicotine Patch: 12 weeks post quit date 21 mg: 4 weeks 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
2.b. Nicotine Replacement Therapy for \< 20 cigarettes per day
Nicotine Patch: 12 weeks post quit date 21 mg: 4 weeks after quit date 14 mg: Next 4 weeks 7 mg: Last 4 weeks
Nicotine chewing gums 2 mg for 12 weeks post quit date (12/day on week 1(Tapering dose)1/day on week 12
Nicotine patch, Nicotine gums
Nicotine patch 21mg, 12 weeks post quit date and nicotine chewing gums 4mg for 12 weeks post quit date
* 14 mg: Next 4 weeks
* 7 mg: Last 4 weeks
Brief Advice (5 A's & 5 R's)
Brief Advice (5 A's \& 5 R's) at Day 0, 1 month, 3,6,9 \& 12 months
Interventions
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Nicotine patch, Nicotine gums
Nicotine patch 21mg, 12 weeks post quit date and nicotine chewing gums 4mg for 12 weeks post quit date
* 14 mg: Next 4 weeks
* 7 mg: Last 4 weeks
Brief Advice (5 A's & 5 R's)
Brief Advice (5 A's \& 5 R's) at Day 0, 1 month, 3,6,9 \& 12 months
Nicotine Patch: Preloading for 4 weeks
Nicotine Patch: Preloading for 4 weeks - 21 mg: 4 weeks before quit date
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
Yes
Sponsors
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Nazarbayev University
OTHER
Astana Medical University
OTHER
Responsible Party
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Chethan Purushothama
Assistant Professor
Locations
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National Research Cardiac Surgery Center, Astana, Kazakhstan
Astana, , Kazakhstan
Nazarbayev University School of Medicine
Astana, , Kazakhstan
Countries
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Facility Contacts
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Chetan Purushothama
Role: primary
References
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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.
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.
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.
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.
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.
Prochaska JJ. Nicotine Replacement Therapy as a Maintenance Treatment. JAMA. 2015 Aug 18;314(7):718-9. doi: 10.1001/jama.2015.7460.
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.
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.
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.
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.
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.
Related Links
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Carbon monoxide breath analyzers and its role in tobacco cessation: A narrative review of literature.
Other Identifiers
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11022021CRP1514
Identifier Type: -
Identifier Source: org_study_id
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