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

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

Detailed Description
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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.

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

Conditions
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Smoking Cessation, Smoking, Cigarette, Smoking Behaviors

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine replacement therapy (NRT) Preloading<br>Brief Advice (5 A's & 5 R's)- 0-day, Month- 1, 3, 6, 9, 12 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<br>* 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<br>* Other names: Nicotex;Behavioral: Brief Advice (5 A's & 5 R's)<br>* Brief Advice (5 A's & 5 R's) at Day 0, 1 month, 3,6,9 & 12 months<br>Drug: Nicotine Patch: Preloading for 4 weeks<br>* Nicotine Patch: Preloading for 4 weeks - 21 mg: 4 weeks before quit date<br>|
| Active Comparator: Nicotine replacement therapy (NRT)<br>Brief Advice (5 A's & 5 R's)- 0-day, Month- 1, 3, 6, 9, 12 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<br>* 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<br>* Other names: Nicotex;Behavioral: Brief Advice (5 A's & 5 R's)<br>* Brief Advice (5 A's & 5 R's) at Day 0, 1 month, 3,6,9 & 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco, Smoking, Nicotine Patches, Nicotine Gums, Nicotine Replacement Therapy, Preloading