Effectiveness of Preloaded Combination Nicotine Replacement Therapy on Smoking Cessation of Adult Population in Kazakhstan- A Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Self reported smoking during intervention period : Yes/No
研究概览
简要总结
Randomized, controlled, two-armed, single-blinded, superiority trial with 1:1 allocation ratio Nicotine Replacement Therapy(NRT)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all current smokers aged 18 years and above with a motivation to quit
排除标准
- •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
研究组 & 干预措施
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
干预措施: Nicotine patch, Nicotine gums (Drug)
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
干预措施: Brief Advice (5 A's & 5 R's) (Behavioral)
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
干预措施: Nicotine patch, Nicotine gums (Drug)
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
干预措施: Brief Advice (5 A's & 5 R's) (Behavioral)
结局指标
主要结局
Self reported smoking during intervention period : Yes/No
时间窗: 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
时间窗: Salivary cotinine test results before intervention, after the intervention and after follow ups
Salivary cotinine test results before, during and after the intervention
次要结局
- Self reported number of quit attempts of tobacco(Assessed at 3, 6 & 12 months from the starting point of intervention.)
- Self reported number of smoked cigarettes/bidis per day(Assessed at 12 months from the starting point of intervention.)
- Adherence to intervention in days: Self reported(Assessed at 12 months from the starting point of intervention.)
研究者
Chethan Purushothama
Assistant Professor
Nazarbayev University