Electronic Cigarettes and Nicotine Pouches for Smoking Cessation

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.

Conditions

• Role of Tobacco Harm Reduction in Smoking Cessation
• Efficiency and Efficacy of E-cigarettes and Nicotine Pouches
• Adverse Effect of E-cigarettes and Nicotine Pouches

Interventions

DEVICE

E-cigarettes device plus liquid

The four basic care counseling sessions will be held over the course of 48 weeks with the supply of e-cigarettes and liquid. Every 12 weeks, a standard care counseling session will be offered, and it will be followed by a study visit to track any alterations in the user's physical or mental health as well as any side effects from using e-cigarettes.

DRUG

Nicotine Pouches

The four basic care counseling sessions will be held over the course of 48 weeks with a supply of nicotine pouches. Every 12 weeks, a standard care counseling session will be offered, and it will be followed by a study visit to track any alterations in the user's physical or mental health as well as any side effects from using nicotine pouches.

OTHER

Basic care counseling about smoking cessation

The four basic care counseling sessions will be held over the course of 48 weeks. Every 12 weeks, a standard care counseling session will be offered, and it will be followed by a study visit to track any alterations in the user's physical or mental health.

Sponsors & Collaborators

• Foundation for a Smoke Free World INC

  collaborator OTHER

• Alternative Research Initiative

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-12-31

Primary Completion

2024-04-30

Completion

2025-04-30

Countries

• Pakistan

Study Locations