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

What Was Tested

In this early phase 1 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Nicotine replacement therapy (NRT) Preloading (experimental) and Nicotine replacement therapy (NRT) (active comparator).

The registry classes the interventions as behavioral and drug.

More on the Plan

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.

Who Took Part

The registry lists 200 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: All current smokers aged 18 years and above with a motivation to quit.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Therapeutic nicotine (patch, non-peptide) was given.

Those kept unaware of assignments: participant.

It started in 2023-07-01 with completion listed for 2024-12-31.

It ran at 2 sites in Kazakhstan (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Self reported smoking during intervention period : Yes/No (time frame: Assessed at 12 months from the starting point of intervention). Salivary cotinine test results: Positive or Negative (time frame: Salivary cotinine test results before intervention, after the intervention and after follow ups).

It also tracked 3 secondary outcomes, for example Self reported number of quit attempts of tobacco, Self reported number of smoked cigarettes/bidis per day and Adherence to intervention in days: Self reported.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Therapeutic nicotine (patch, non-peptide) in 200 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.