Preloaded Combination Nicotine Replacement Therapy on Smoking Cessation of Adult Population in Kazakhstan

Smoking Cessation Clinical Trial

Official title:

Effectiveness of Preloaded Combination Nicotine Replacement Therapy on Smoking Cessation of Adult Population in Kazakhstan- A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05484505
• Other study ID #: 11022021CRP1514
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Nazarbayev University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized, controlled, two-armed, single-blinded, superiority trial with 1:1 allocation ratio Nicotine Replacement Therapy(NRT)

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• all current smokers aged 18 years and above with a motivation to quit

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Smoking Behaviors
• Smoking Cessation
• Smoking, Cigarette

Intervention

Drug:
• 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

Behavioral:
• 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

Drug:
• Nicotine Patch: Preloading for 4 weeks
Nicotine Patch: Preloading for 4 weeks - 21 mg: 4 weeks before quit date

Locations

Country	Name	City	State
Kazakhstan	National Research Cardiac Surgery Center, Astana, Kazakhstan	Astana
Kazakhstan	Nazarbayev University School of Medicine	Astana

Sponsors (2)

Lead Sponsor	Collaborator
Nazarbayev University	Astana Medical University

Country where clinical trial is conducted

Kazakhstan, 

References & Publications (10)

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. — View 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. — View 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/s40 — View 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. — View 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. — View 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. — View 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. — View Citation

Prochaska JJ. Nicotine Replacement Therapy as a Maintenance Treatment. JAMA. 2015 Aug 18;314(7):718-9. doi: 10.1001/jama.2015.7460. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pattern of smoking	The change in smoking frequency from the baseline information (It can be excess use, reduced use or relapse)	Assessed at 12 months from the starting point of intervention.
Primary	Self reported smoking during intervention period : Yes/No	Self-reported smoking anytime during the intervention or follow-up period	Assessed at 12 months from the starting point of intervention.
Primary	Salivary cotinine test results: Positive or Negative	Salivary cotinine test results before, during and after the intervention	Salivary cotinine test results before intervention, after the intervention and after follow ups
Secondary	Self reported number of quit attempts of tobacco	Number of quit attempts of tobacco since enrolment	Assessed at 3, 6 & 12 months from the starting point of intervention.
Secondary	Self reported number of smoked cigarettes/bidis per day	Number of smoked cigarettes/bidis per day since enrolment	Assessed at 12 months from the starting point of intervention.
Secondary	Adherence to intervention in days: Self reported	Self reported duration of use of the intervention in days	Assessed at 12 months from the starting point of intervention.

External Links

•   Carbon monoxide breath analyzers and its role in tobacco cessation: A narrative review of literature.