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

Early Phase 1UnknownNCT05484505

Nazarbayev University200 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Smoking Cessation Smoking, Cigarette Smoking Behaviors

Interventions

Nicotine patch, Nicotine gumsDRUG

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

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 Patch: Preloading for 4 weeksDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

National Research Cardiac Surgery Center, Astana, Kazakhstan

Astana, Kazakhstan

Nazarbayev University School of Medicine

Astana, Kazakhstan

Outcomes

Primary Outcomes

Self reported smoking during intervention period : Yes/No

Self-reported smoking anytime during the intervention or follow-up period

Time frame: 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

Time frame: Salivary cotinine test results before intervention, after the intervention and after follow ups

Secondary Outcomes

Self reported number of quit attempts of tobacco

Number of quit attempts of tobacco since enrolment

Time frame: 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

Time frame: 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

Time frame: Assessed at 12 months from the starting point of intervention.

Data from ClinicalTrials.gov

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