NCT05484505

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

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Nazarbayev University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smoking Cessation
• Smoking, Cigarette
• Smoking Behaviors

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-08-02
• Last updated: 2023-03-24

Locations

2 sites across 1 country: Kazakhstan