Electronic Cigarettes and Nicotine Pouches for Smoking Cessation

Alternative Research Initiative

Status and phase: Not yet enrolling; Early Phase 1

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

Treatments: Other: Basic care counseling about smoking cessation; Device: E-cigarettes device plus liquid; Drug: Nicotine Pouches

Study type: Interventional

Funder types: Other

Identifiers

NCT05715164

P-0094

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

E-cigarettes device plus liquid

Experimental group

Description:

The 200 participants will receive e-cigarettes along with basic care counseling for 48 weeks.

Treatment:

Device: E-cigarettes device plus liquid

Nicotine Pouches

Experimental group

Description:

The 200 participants will receive nicotine pouches along with basic care counseling for 48 weeks.

Treatment:

Drug: Nicotine Pouches

Basic care counseling about smoking cessation

Active Comparator group

Description:

The 200 participants will receive basic care counseling for 48 weeks.

Treatment:

Other: Basic care counseling about smoking cessation