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

Sponsor

Nazarbayev University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05484505

Collaborator

Astana Medical University (Other)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation Smoking, Cigarette Smoking Behaviors	Drug: Nicotine patch, Nicotine gums Behavioral: Brief Advice (5 A's & 5 R's) Drug: Nicotine Patch: Preloading for 4 weeks	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nicotine replacement therapy (NRT) Preloading 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 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 Other Names: Nicotex 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
Active Comparator: Nicotine replacement therapy (NRT) 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 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 Other Names: Nicotex 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

Arm

Intervention/Treatment

Experimental: Nicotine replacement therapy (NRT) Preloading

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

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

Other Names:

Nicotex

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

Active Comparator: Nicotine replacement therapy (NRT)

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

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

Other Names:

Nicotex

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

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Pattern of smoking [Assessed at 12 months from the starting point of intervention.]
The change in smoking frequency from the baseline information (It can be excess use, reduced use or relapse)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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