Electronic Cigarettes and Nicotine Pouches for Smoking Cessation
Status:
Not yet recruiting
Trial end date:
2025-04-01
Target enrollment:
Participant gender:
Summary
Pakistan is one of the most vulnerable low- and middle-income countries with 29 million adult
active tobacco users. Smoking cessation services are lacking as the tobacco control
initiatives have largely failed to address the smoking endemic. Over the last five years,
Pakistan has witnessed the use of innovative tobacco harm reduction such as e-cigarettes,
nicotine pouches, and non-nicotine replacement therapies (non-NRTs). However, their use
remains limited.
THR products are imported legally as consumer goods and are taxable. The lack of sufficient
data for THR and its application is a challenge in gauging their effectiveness in assisting
smokers to quit combustible smoking. Evidence-based studies on e-cigarettes and other
nicotine products are required to gauge the effectiveness of e-cigarettes and nicotine
pouches as smoking cessation aids.
Keeping in view the study objectives, a sample size of 600 participants will be sufficient to
assess the effectiveness of e-cigarettes and nicotine pouches for smoking cessation in
Pakistan. Of these, 200 participants each will receive e-cigarettes and nicotine pouches
along with basic care counseling, while the remaining 200 participants will only receive
basic care counseling for 48 weeks. The association of participants' characteristics with
smoking and health status will be based on bivariate and multivariate analysis. The simple
t-test and variance analysis will assess the differences in intervention indicators between
the control and treatment groups. For the inferential analysis, the average treatment impact
of the treatments will find using quasi-experimental techniques such as difference in
difference (DID) or Propensity Score Matching (PMS).
This study will be evaluated participants at baseline, after their self-decided "quit date,".
The follow-up will be a survey every 12 weeks. Results may inform the public,
decision-makers, and researchers about the use of e-cigarettes and nicotine pouches helping
smokers to quit smoking or switch to less harmful alternatives in the short- and medium-term
periods.