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

Early Phase 1

Not yet recruiting

• Conditions: Smoking Behaviors; Smoking Cessation; Smoking, Cigarette
• Interventions: Drug: Nicotine patch, Nicotine gums; Behavioral: Brief Advice (5 A's & 5 R's)

• Registration Number: NCT05484505
• Lead Sponsor: Nazarbayev University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2022-07-22
• Study First Submitted QC: 2022-07-30
• Study First Posted: 2022-08-02
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-24
• Study Start: 2023-07-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine replacement therapy (NRT) Preloading	Nicotine patch, Nicotine gums	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 replacement therapy (NRT) Preloading	Brief Advice (5 A's & 5 R's)	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 replacement therapy (NRT)	Brief Advice (5 A's & 5 R's)	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 replacement therapy (NRT)	Nicotine patch, Nicotine gums	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

Primary Outcome Measures

Name	Time	Method
Self reported smoking during intervention period : Yes/No	Assessed at 12 months from the starting point of intervention.	Self-reported smoking anytime during the intervention or follow-up period
Salivary cotinine test results: Positive or Negative	Salivary cotinine test results before intervention, after the intervention and after follow ups	Salivary cotinine test results before, during and after the intervention

Secondary Outcome Measures

Name	Time	Method
Self reported number of quit attempts of tobacco	Assessed at 3, 6 & 12 months from the starting point of intervention.	Number of quit attempts of tobacco since enrolment
Self reported number of smoked cigarettes/bidis per day	Assessed at 12 months from the starting point of intervention.	Number of smoked cigarettes/bidis per day since enrolment
Adherence to intervention in days: Self reported	Assessed at 12 months from the starting point of intervention.	Self reported duration of use of the intervention in days

Trial Locations

Locations (2)

National Research Cardiac Surgery Center, Astana, Kazakhstan; 🇰🇿 Astana, Kazakhstan

Nazarbayev University School of Medicine; 🇰🇿 Astana, Kazakhstan