Clinical trial NCT05484505: Preloaded Combination Nicotine Replacement Therapy on Smoking Cessation of Adult Population in Kazakhstan
Official title: Effectiveness of Preloaded Combination Nicotine Replacement Therapy on Smoking Cessation of Adult Population in Kazakhstan- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Smoking Cessation
Smoking, Cigarette
Smoking Behaviors
Keywords: Tobacco
Smoking
Nicotine Patches
Nicotine Gums
Nicotine Replacement Therapy
Preloading
Lead sponsor: Nazarbayev University
Sponsor class: OTHER
Collaborators: name: Astana Medical University
First posted: 2022-08-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self reported smoking during intervention period : Yes/No
timeFrame: Assessed at 12 months from the starting point of intervention.
measure: Salivary cotinine test results: Positive or Negative
timeFrame: Salivary cotinine test results before intervention, after the intervention and after follow ups
Secondary outcomes:
measure: Self reported number of quit attempts of tobacco
timeFrame: Assessed at 3, 6 & 12 months from the starting point of intervention.
measure: Self reported number of smoked cigarettes/bidis per day
timeFrame: Assessed at 12 months from the starting point of intervention.
measure: Adherence to intervention in days: Self reported
timeFrame: Assessed at 12 months from the starting point of intervention.
Other outcomes:
measure: Pattern of smoking
timeFrame: Assessed at 12 months from the starting point of intervention.
Locations:
city: Astana
country: Kazakhstan
facility: National Research Cardiac Surgery Center, Astana, Kazakhstan
city: Astana
country: Kazakhstan
facility: Nazarbayev University School of Medicine
Study officials:
References:
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