Electronic Cigarettes and Nicotine Pouches for Smoking Cessation

Electronic Cigarettes and Nicotine Pouches for Smoking Cessation in Pakistan: A Randomized Controlled Trial

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Abdul Hameed, PhD; Phone Number: +923315813713; Email: hameedleghari@gmail.com
• Study Contact Backup: Name: Daud Malik, MA; Phone Number: +923028560310; Email: daud31us@yahoo.com

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Rawalpindi and Islamabad Centre
      • Contact: Sarnawaz Salamat, Msc; Email: sarnawaaz@gmail.com
      • Principal Investigator: Juniad Khan, Msc
      • Sub-Investigator: Sarnawaz Salamat, Msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: E-cigarettes device plus liquid; The 200 participants will receive e-cigarettes along with basic care counseling for 48 weeks.	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.
EXPERIMENTAL: Nicotine Pouches; The 200 participants will receive nicotine pouches along with basic care counseling for 48 weeks.	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.
ACTIVE_COMPARATOR: Basic care counseling about smoking cessation; The 200 participants will receive basic care counseling for 48 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants reported adverse events of e-cigarettes or nicotine pouches	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.	60 Weeks
Change in the number of combustible cigarettes per day	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.	60 Weeks
Point-prevalence abstinence	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).	60 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
7-day point-prevalence abstinence and harm reduction	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.	60 Weeks

Collaborators and Investigators

• Sponsor: Alternative Research Initiative
• Collaborators: Foundation for a Smoke-Free World

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2023
• Primary Completion (ANTICIPATED): April 1, 2024
• Study Completion (ANTICIPATED): April 1, 2025

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (ACTUAL): February 6, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Smoking Cessation; Nicotine Replacement Therapy; E-cigarettes; Tobacco Control; Tobacco Harm Reduction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: P-0094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No