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

NCT06063421 | Not Yet Recruiting

• 1 other identifier: QUITS 3.1
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

comparison of electronic cigarettes and NRT; electronic cigarettes versus NRT; electronic cigarettes; E-cigarettes; Nicotine Replacement Therapy (NRT); Electronic Nicotine delivery Systems (ENDS); EC; NRT; Quit smoking; smoking cessation; Tobacco cessation; Alternate Nicotine Delivery Systems (ANDS)

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (1)

• Biochemically verified sustained smoking abstinence at 24 weeks after the Target Quit Day

  24 weeks from Target Quit Day.

Other Outcomes (5)

• 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.

• 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.

Study Arms (2)

Nicotine Replacement Therapy (NRT)

ACTIVE COMPARATOR

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.

Drug: Nicotine Replacement Therapy

Electronic Cigarettes (EC)

EXPERIMENTAL

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.

Device: Electronic Cigarette (EC)

Interventions

Electronic Cigarette (EC) DEVICE

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.

Also known as: e-cigarettes, electronic nicotine delivery system (ENDS), Alternative nicotine delivery systems (ANDS), e-cigs

Electronic Cigarettes (EC)

Nicotine Replacement Therapy DRUG

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.

Also known as: NRT

Nicotine Replacement Therapy (NRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 years or older).
• Current-smokers presenting to a cessation clinic expressing a desire to quit smoking.
• Has capacity to consent.
• Can read and understand the instructions in Urdu and/or English and follow the study instructions and procedures.

You may not qualify if:

• Pregnant or breastfeeding women.
• Currently using EC or NRT products.
• Already enrolled in another similar study.
• Not willing to quit.
• Patients who have had a recent cardiovascular event like unstable angina, stroke or myocardial infarction in the past 2 weeks.

Sponsors & Collaborators

• Strategic Health Research Limited: lead
• Foundation for a Smoke Free World INC: collaborator

Study Sites (1)

Health Research Consulting

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Smoking Cessation; Vaping; Tobacco Use Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Muzaffar Malik, MPH

  Head of Statistics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fouad Aslam, MPH

CONTACT

00447494700290; projectdirector@strategichealthresearch.org.uk

Aftab Ahmad, MA

CONTACT

projectmanager@strategichealthresearch.org.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This is a pragmatic, open label, parallel design RCT.

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: October 2, 2023
• Study Start: June 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: November 30, 2025
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 3 months after publication of study for a period of 5 years.

Locations

PA (1)