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

NCT05484505 | Unknown Early Phase 1

• 1 other identifier: 11022021CRP1514
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Smoking Cessation; Smoking, Cigarette; Smoking Behaviors

Keywords

Tobacco; Smoking; Nicotine Patches; Nicotine Gums; Nicotine Replacement Therapy; Preloading

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (3)

• Self reported number of quit attempts of tobacco

  Assessed at 3, 6 & 12 months from the starting point of intervention.

• Self reported number of smoked cigarettes/bidis per day

  Assessed at 12 months from the starting point of intervention.

• Adherence to intervention in days: Self reported

  Assessed at 12 months from the starting point of intervention.

Other Outcomes (1)

• Pattern of smoking

  Assessed at 12 months from the starting point of intervention.

Study Arms (2)

Nicotine replacement therapy (NRT) Preloading

EXPERIMENTAL

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

Drug: Nicotine patch, Nicotine gums; Behavioral: Brief Advice (5 A's & 5 R's); Drug: Nicotine Patch: Preloading for 4 weeks

Nicotine replacement therapy (NRT)

ACTIVE COMPARATOR

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

Drug: Nicotine patch, Nicotine gums; Behavioral: Brief Advice (5 A's & 5 R's)

Interventions

Nicotine patch, Nicotine gums DRUG

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

Also known as: Nicotex

Nicotine replacement therapy (NRT); Nicotine replacement therapy (NRT) Preloading

Brief Advice (5 A's & 5 R's) BEHAVIORAL

Brief Advice (5 A's \& 5 R's) at Day 0, 1 month, 3,6,9 \& 12 months

Nicotine replacement therapy (NRT); Nicotine replacement therapy (NRT) Preloading

Nicotine Patch: Preloading for 4 weeks DRUG

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

Nicotine replacement therapy (NRT) Preloading

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nazarbayev University: lead
• Astana Medical University: collaborator

Study Sites (2)

National Research Cardiac Surgery Center, Astana, Kazakhstan

Astana, 010000, Kazakhstan

Location

Nazarbayev University School of Medicine

Astana, 010000, Kazakhstan

Location

Related Publications (11)

• 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: 20884658 RESULT

• 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: 30932386 RESULT

• 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: 31241286 RESULT

• 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: 32578165 RESULT

• 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: 11717401 RESULT

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

  PMID: 26284723 RESULT

• 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: 29486753 RESULT

• 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: 22320954 RESULT

• 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: 9725117 RESULT

• 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: 9583654 RESULT

• 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.

  PMID: 38011129 DERIVED

Related Links

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

MeSH Terms

Conditions

Smoking Cessation; Cigarette Smoking; Smoking

Interventions

Tobacco Use Cessation Devices; Crisis Intervention

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Tobacco Smoking; Tobacco Use

Intervention Hierarchy (Ancestors)

Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 2, 2022
• Study Start: July 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available from the corresponding author on reasonable request.
• Access Criteria: Data will be available from the corresponding author on reasonable request via e-mail

Locations

KA (2)