Electronic Cigarettes and Nicotine Pouches for Smoking Cessation

• Status: Not yet recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alternative Research Initiative (Pvt.) Ltd
• Collaborator: Foundation for a Smoke-Free World
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• Participants who are at least eighteen years old.

• More than 10 combustible cigarettes smoke a day at the time of study enrollment.

• Smoked cigarettes for at least a year.

• Participants are willing to stop combustible smoking.

• Participants who can sign a written consent form.

• There can only be one applicant per household.

• Own a phone that supports text massaging.

Exclusion Criteria:

• Women who are pregnant.

• Childbearing mothers.

• Currently using other nicotine- and non-nicotine-based cessation therapies.

• Expectant ladies who intend to become pregnant during the trial's participation term.

• Experienced chest pain, or another cardiovascular event or procedure (e.g., heart attack, stroke, insertion of stent, bypass surgery).