Electronic Cigarettes and Nicotine Pouches for Smoking Cessation

Early Phase 1

Not yet recruiting

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

• Registration Number: NCT05715164
• Lead Sponsor: Alternative Research Initiative

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-09
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-03
• Last Update Submitted: 2023-02-03
• Study First Posted: 2023-02-06
• Last Update Posted: 2023-02-06
• Study Start: 2023-12
• Primary Completion: 2024-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine Pouches	Nicotine Pouches	The 200 participants will receive nicotine pouches along with basic care counseling for 48 weeks.
E-cigarettes device plus liquid	E-cigarettes device plus liquid	The 200 participants will receive e-cigarettes along with basic care counseling for 48 weeks.
Basic care counseling about smoking cessation	Basic care counseling about smoking cessation	The 200 participants will receive basic care counseling for 48 weeks.

Primary Outcome Measures

Name	Time	Method
Number of participants reported adverse events of e-cigarettes or nicotine pouches	60 Weeks	The primary outcome will be a long-term change in health status. The best proxy indication for demonstrating a change in tobacco smoking, which is adequate to result in a clinically relevant long-term health benefit, is unknown. In the absence of accurate health indicators, we will use the change in smoking rate from baseline and smoking cessation as primary outcomes.
Change in the number of combustible cigarettes per day	60 Weeks	This study will evaluate the impact of e-cigarettes and nicotine pouches on cigarettes per day (CPD) and smoking cessation (7 Day Point Abstinence) at weeks 24 and 48.
Point-prevalence abstinence	60 Weeks	Self-reported point-prevalence abstinence in the previous week with biochemical validation will be used exhaled carbon monoxide less than 10 parts per million (PPM).

Secondary Outcome Measures

Name	Time	Method
7-day point-prevalence abstinence and harm reduction	60 Weeks	Secondary outcomes will include 7-day point-prevalence abstinence (at all subsequent check-ups) (biochemically validated at weeks 12, 24, 36, 48, and 60). As a secondary goal, this study will analyze the harm-reduction effect of e-cigarettes and nicotine pouches, as well as the analysis of adverse events.

Trial Locations

Locations (1)

Rawalpindi and Islamabad Centre; 🇵🇰 Rawalpindi, Punjab, Pakistan