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A Randomized Controlled Trial (RCT) to Compare Efficacy of Nicotine Replacement Therapy (NRT) Versus Electronic Cigarettes (EC) for Quitting Tobacco Smoking in Pakistan
Sponsor study identifier
interventional
438
1 country
1
Study Start
June 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 4, 2023
Actual (reported)October 2, 2023
Actual (reported)June 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Carbon Monoxide (CO) validated sustained abstinence at 52 weeks (1 year)
The primary outcome measure will be a biochemically (carbon monoxide) validated abstinence from smoking measured at 52 weeks (1 year) post target quit day.
52 weeks from Target Quit day (TQD).
Biochemically verified sustained smoking abstinence at 24 weeks after the Target Quit Day
24 weeks from Target Quit Day.
Self-reported 7-day point prevalence abstinence at 4, 24 and 52 weeks.
This self-reported 7-day point prevalence will be conducted at 4, 24 and 52 weeks post target quit day.
The arm will comprise participants that receive NRT. The NRT used will be combination therapy; transdermal Nicotine patches will be combined with faster-acting oral products like gum or lozenges. The strength of nicotine patches will be from 7 to 21 mg, and for gum or lozenges, the strength will be 1-4 mg. Usage will be in the form of a daily nicotine patch and ad libitum use of the faster-acting lozenge to curb nicotine cravings. Participants will be provided with a 12-week supply of NRT.
Participants randomised to the EC group will be supplied with an EC starter kit. The kit will consist of a personal vaping device with an integrated battery. Three commonly used flavours of e-liquid (tobacco, menthol, and fruit flavours) will be provided. All e-liquids will have a nicotine concentration of 18-20 mg/ml. EC will be provided for a total of 12 weeks.
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.
Health Research Consulting
Islamabad, 44000, Pakistan
Muzaffar Malik, MPH
Head of Statistics
First Submitted
September 4, 2023
First Posted
October 2, 2023
Study Start
June 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Adverse reactions
Adverse reactions will be recorded on 1, 4, 8, 24 and 52 weeks post TQD.
Change in number of cigarettes smoked per day (CPD).
CPD will be measured at 1, 4, 8, 24 and 52 weeks post TQD.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 25, 2024
Record last verified: 2024-03
The study will share IPD once the study has been completed and results published. All relevant data like study protocol, statistical analysis, consent form, etc will be shared.
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Source: ClinicalTrials.gov.
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