Smoking Behaviors, Smoking Cessation, Smoking, Cigarette
Conditions
Keywords
Tobacco, Smoking, Nicotine Patches, Nicotine Gums, Nicotine Replacement Therapy, Preloading
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.
Interventions
DRUGNicotine 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
BEHAVIORALBrief 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
DRUGNicotine Patch: Preloading for 4 weeks
Nicotine Patch: Preloading for 4 weeks - 21 mg: 4 weeks before quit date
Sponsors
Astana Medical University
Nazarbayev University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self reported smoking during intervention period : Yes/No | 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 | Salivary cotinine test results before intervention, after the intervention and after follow ups | Salivary cotinine test results before, during and after the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self reported number of quit attempts of tobacco | Assessed at 3, 6 & 12 months from the starting point of intervention. | Number of quit attempts of tobacco since enrolment |
| Self reported number of smoked cigarettes/bidis per day | Assessed at 12 months from the starting point of intervention. | Number of smoked cigarettes/bidis per day since enrolment |
| Adherence to intervention in days: Self reported | Assessed at 12 months from the starting point of intervention. | Self reported duration of use of the intervention in days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pattern of smoking | Assessed at 12 months from the starting point of intervention. | The change in smoking frequency from the baseline information (It can be excess use, reduced use or relapse) |
Countries
Kazakhstan
Outcome results
None listed