Comparison of Nicotine Replacement Therapy and Electronic Cigarettes for Smoking Cessation in Pakistan

Summary

Smoking is prevalent in Pakistan, and a large proportion of the adult population smokes cigarettes or uses other forms of tobacco. Smoking cessation programmes are not well established, and the few centres that offer cessation, only provide basic support without stop-smoking medicines or other aids that can help people quit. Internationally approved stop-smoking treatments like nicotine replacement therapy (NRT) are available in larger cities, but they are very expensive. This makes it difficult for the general population to use NRT to aid in their desire to quit smoking. In the past few years, the use of electronic cigarettes (EC) has increased manifold. These devices are freely available and are offered in a wide variety of types and flavours. EC are also cheaper compared to NRT, which makes them affordable for most smokers. EC are not considered smoking cessation tools and are not used or recommended by cessation services. This study wants to compare EC with NRT to see which treatment is more successful in helping people quit smoking. The premise is that EC are more effective than NRT. The study also wants to determine the cost of using EC compared to that of NRT, when used for quitting smoking.

The study will have a total of 438 participants who will be assigned randomly (by chance) to two groups: NRT and EC. 219 participants will be provided with NRT, and 219 with EC. The participants will be adult smokers presenting at designated smoking cessation centres who are seeking help in quitting smoking. The main focus of the study is to see if EC are more successful than NRT in helping people quit smoking at the end of one year.

This research will provide useful information on the effectiveness and safety of EC and help develop a smoking cessation policy tailored to the population of Pakistan.

Conditions

• Smoking Cessation
• Electronic Cigarette Use

Interventions

DEVICE

Electronic Cigarette (EC)

The intervention consists of the use of an Electronic cigarette device namely the Vaporesso Gen Air 40 Vape Kit. This is a complete kit including the EC device, integrated battery, refillable tank, charging cable, coil replacements and user manual. Three e-liquid flavours will be provided; tobacco, menthol and fruit flavour.

DRUG

Nicotine Replacement Therapy

NRT will be in the form of combination therapy with a transdermal nicotine patch (7, 14, or 21mg) and an oral product: either gum or lozenge in 1, 2, or 4mg strength.

Sponsors & Collaborators

• Foundation for a Smoke Free World INC

  collaborator OTHER

• Strategic Health Research Limited

  lead NETWORK

Principal Investigators

• Muzaffar Malik, MPH · Head of Statistics

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-06-01

Primary Completion

2025-05-31

Completion

2025-11-30

Countries

• Pakistan

Study Locations