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

Nazarbayev University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Smoking, Cigarette; Smoking Behaviors; Smoking Cessation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05484505

11022021CRP1514

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Nicotine replacement therapy (NRT) Preloading

Experimental group

Description:

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

Treatment:

Drug: Nicotine Patch: Preloading for 4 weeks

Drug: Nicotine patch, Nicotine gums

Behavioral: Brief Advice (5 A's & 5 R's)

Nicotine replacement therapy (NRT)

Active Comparator group

Description:

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

Treatment:

Drug: Nicotine patch, Nicotine gums

Behavioral: Brief Advice (5 A's & 5 R's)