Smoking CessationPhase 3NCT05825924
Effectiveness of Different THR Products in Adult Population
A Phase 3 study testing E-Cigarette and Nicotine patch in people with Smoking Cessation, run by Foundation for a Smoke Free World INC at 1 site in Pakistan.
Trial summary
The study is a two-arm, parallel randomized controlled trial (RCT) with a treatment period of 12 weeks, and long-term follow-up at 52 weeks which plans to enroll 258 smokers from general adult population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- E-Cigarette and Nicotine patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 sitePakistan
- Study dates
- Jun 2024to Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both genders of legal age allowed for smoking as per country law
- Smoked at least 10 cigarettes a day for the past one year
- Exhaled breath CO (eCO) level > 10 ppm
- Wish to quit smoking
- Able to conform with all study procedures
- Have a mobile phone
- Expected to be available for follow up will be enrolled as study participants
Who cannot join
- Pregnant and breastfeeding women
- Using other smoking cessation medications (including other forms of NRT other than patch, bupropion, clonidine, nortriptyline or varenicline)
- Having any contraindications to products such as cardiovascular history
- Suffering from a major illness with prognosis of less than 1 year
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
South East Hospital and Research Centre
Islamabad, Federal, 44000
Ather Mehmood, FCPS, +92518314299, athermehmood70@gmail.com
About this study
Official title: Randomized, Two Arm Parallel, Clinical Trial to Compare Effectiveness of Different Tobacco Harm Reduction Products in General Adult Population in Low Middle Income Countries
The study is a two-arm, parallel randomized controlled trial (RCT) with a treatment period of 12 weeks, and long-term follow-up at 52 weeks which plans to enroll 258 smokers from general adult population. Participants who meet the eligibility criteria and give their informed consent will be randomized (1:1) to one of two treatment arms: (1) E-cigarettes (18mg/ml) with individual counselling (2) Nicotine patches (21mg) with individual counselling. Eligible participants must be at least of legal age allowed for smoking in the country, of either gender, regular smokers (minimum 10 cigarettes/day for at least a year) and interested to stop smoking. Participants will be scheduled for a screening visit and a baseline (BL) visit at the trial site. The participants will be scheduled for eight study visits in total, including five treatment sessions and three follow-up visits, using both face to face interaction at trial site as well as follow up on telephone. Eight study visits are planned at weeks 1, 2, 4, 8, 12, 18, 24, and 52. Exhaled carbon monoxide assessment will be used at the trial site to quantify biochemically validated smoking abstinence. All secondary outcomes and self-reported usage of nicotine patches, EC and cigarettes will be monitored throughout the study.
Read the detailed description
This is a two-arm, parallel randomized controlled trial with a 12 weeks treatment duration and long-term 52 weeks follow-up. Outpatient, and walk-in clinics, and advertising will be used to recruit participants from the general population. Individual counselling regarding smoking cessation will be provided to the participants using EC as well as nicotine patches. Participants included must be at least of legal age allowed for smoking in the country, of either gender, regular smokers (minimum 10 cigarettes/day for at least a year) and interested to stop smoking. Participants will be scheduled for a screening visit and a baseline (BL) visit at the trial site. The participants will be scheduled for eight study visits in total, including five treatment sessions and three follow-up visits, using both face to face interaction at trial site as well as follow up on telephone. Eight study visits are planned at weeks 1, 2, 4, 8, 12, 18, 24, and 52. Exhaled carbon monoxide assessment will be used at the trial site to quantify biochemically validated smoking abstinence (exhaled carbon monoxide levels above ten ppm regarded as indicator of current smoking). All secondary outcomes and self-reported usage of nicotine patches, EC and cigarettes will be monitored throughout the study. Information about self-reported smoking, usage of EC and nicotine patches, use of other smoking cessation therapy and side effects will be gathered at all follow-up calls and visits.
- Conditions
- Smoking Cessation
- Being tested
- E-Cigarette, Nicotine patch
- Keywords
- smoking cessation, tobacco harm reduction, E Cigarettes, LMIC
- Medical subject headings
- Smoking Cessation, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-CigaretteDevice
E-cigarettes have been designed to resemble tobacco cigarettes. They include an aerosol generator, sensor, battery and storage area for liquid. They are either disposable or rechargeable. According to a study, e-cigarettes can deliver an average of 1.3 mg (range 0.4 to 2.6 mg) of nicotine from 15 puffs. Average Cmax after e-cigarette use is recorded as 8.4 ng/mL and Tmax achieved between 2 to 5 minutes
Nicotine patchDrug
Also called Patch
The nicotine patches are applied on the skin and nicotine is delivered at a steady rate. After administration, the peak blood levels are achieved within 6-10 hours. The levels remain constant, reducing by 25-40% with use of patches once daily. The patch is typically administered every 24 hours for no longer than 12 weeks. The dose of the patches is often determined by daily cigarette consumption and level of addiction.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm A: Electronic Cigarettes (18mg/ml) | Active comparator | Participants randomized to study arm A will be provided a free e-cigarette and sufficient nicotine cartridges (18 mg/ml) supply to last till next in person visit. Participants will be instructed to use the device ad libitum one week before their quit day to familiarize themselves with its operation and on their designated quit day will stop smoking tobacco cigarettes and instead use the e-cigarette exclusively for the next 12 weeks. Smokers often take 10 to 15 puffs over the course of 5 to 8 minutes, repeating this pattern with each cigarette. On the other hand, users of EC may periodically use it throughout the day, and they may or may not take their puffs like those of traditional cigarettes Receives: Device: E-Cigarette |
| Study Arm B: 21 mg nicotine patches | Active comparator | Participants randomized to study arm B will be provided 21 mg nicotine patches supply to last till next in person visit. Participants will use the nicotine patch daily for one week before their quit day to familiarize themselves with its use. On their designated quit day they will stop smoking and use nicotine patches daily for the next 12 weeks. Usually a full-strength patch (15-22 mg of nicotine) daily for four weeks is suggested for use in majority of the smokers, followed by a lower strength patch (5-14 mg of nicotine) for an additional four weeks, depending on their body size and smoking habits Receives: Drug: Nicotine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point-prevalence abstinence
Number of participants self-reported abstinence in the past week, with biochemical validation using exhaled CO measurements of ≤ 10 ppm.
Measured: 12 weeks
Secondary outcomes (5)
Seven-day point prevalence
Number of Participants who self-report having smoked no cigarettes in the past 7 days
Measured: 7 days for 12 weeks
Use of tobacco combustible cigarettes
Number of cigarettes smoked per day assessed using self reported diaries
Measured: 12 weeks
Perception of the product
Participant views on using e-cigarettes or patches as a smoking cessation aid using Modified Cigarette Evaluation Questionnaire. The mCEQ consist of 12 questions for rating using Likert scale which ranges from 1 (not at all) to 7 (extremely). The answers are combined to form five unique subscales each made up of 1-5 items which quantify (1) Satisfaction, (2) Psychological Reward, (3) Enjoyment of Respiratory Tract Sensations, (4) Craving and (5) Aversion. Difference scores can range from -6 to +6 with positive scores indicating higher dose cigarette produce greater intensity of a subjective effect.
Measured: 12 weeks
Adverse events
Adverse events related to e cigarettes and nicotine patches evaluated using Naranjo Adverse Drug Reaction Probability Scale. Total scores range from -4 to +13 with higher scores indicating definite adverse drug reaction; the reaction is considered definite and adverse reaction is present if the score is 9 or higher, probable if 5 to 8, possible if 1 to 4, and doubtful if 0 or less.
Measured: 12 weeks
Physical signs and symptoms associated with withdrawal
Physical sign and symptoms of withdrawal using Fagerstrom test for nicotine dependence. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. In scoring the Fagerstrom Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are computed to yield a total score of 0-10. The higher the total Fagerstrom score, the more intense is the participant's physical dependence on nicotine.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study startJun 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants who are eligible and consent to take part will be randomized (1:1 ratio) to receive products accordingly: A total of 258 participants will be enrolled (129 in each arm) and randomized to Study Arm A: 18 mg nicotine e-cigarettes (ad libitum use) for 12 weeks after the nominated quit date; and Study Arm B: 21 mg nicotine patches (one daily) for 12 weeks after the nominated quit date. The duration of counseling will be at least 30 minutes at site. The duration of counseling through telephone will be at least 10 minutes. Participants will be scheduled for a screening visit and a baseline (BL) visit at the trial site. The participants will be scheduled for eight study visits in total, including five treatment sessions and three follow-up visits, using both face to face interaction at trial site as well as follow up on telephone. Eight study visits are planned at weeks 1, 2, 4, 8, 12, 18, 24, and 52.
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation for a Smoke Free World INC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Madeeha Malik, Foundation for a Smoke Free World INC
- Investigators
- Madeeha Malik, PhD, Principal investigator, Cyntax Health Projects PVT LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825924
- Sponsor's protocol ID
- W3-030
- Status last verified
- Nov 2023
- First submitted
- 14 Mar 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Two Arm Parallel, Clinical Trial to Compare Effectiveness of Different Tobacco Harm Reduction Products in General Adult Population in Low Middle Income Countries
- ClinicalTrials.gov ID
- NCT05825924
- Acronym / sponsor ID
- W3-030
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, tobacco harm reduction, E Cigarettes, LMIC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Foundation for a Smoke Free World INCUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a two-arm, parallel randomized controlled trial (RCT) with a treatment period of 12 weeks, and long-term follow-up at 52 weeks which plans to enroll 258 smokers from general adult population. Participants who meet the eligibility criteria and give their informed consent will be randomized (1:1) to one of two treatment arms: (1) E-cigarettes (18mg/ml) with individual counselling (2) Nicotine patches (21mg) with individual counselling. Eligible participants must be at least of legal age allowed for smoking in the country, of either gender, regular smokers (minimum 10 cigarettes/day for at least a year) and interested to stop smoking. Participants will be scheduled for a screening visit and a baseline (BL) visit at the trial site. The participants will be scheduled for eight study visits in total, including five treatment sessions and three follow-up visits, using both face to face interaction at trial site as well as follow up on telephone. Eight study visits are planned at weeks 1, 2, 4, 8, 12, 18, 24, and 52. Exhaled carbon monoxide assessment will be used at the trial site to quantify biochemically validated smoking abstinence. All secondary outcomes and self-reported usage of nicotine patches, EC and cigarettes will be monitored throughout the study.
Detailed description
This is a two-arm, parallel randomized controlled trial with a 12 weeks treatment duration and long-term 52 weeks follow-up. Outpatient, and walk-in clinics, and advertising will be used to recruit participants from the general population. Individual counselling regarding smoking cessation will be provided to the participants using EC as well as nicotine patches. Participants included must be at least of legal age allowed for smoking in the country, of either gender, regular smokers (minimum 10 cigarettes/day for at least a year) and interested to stop smoking. Participants will be scheduled for a screening visit and a baseline (BL) visit at the trial site. The participants will be scheduled for eight study visits in total, including five treatment sessions and three follow-up visits, using both face to face interaction at trial site as well as follow up on telephone. Eight study visits are planned at weeks 1, 2, 4, 8, 12, 18, 24, and 52. Exhaled carbon monoxide assessment will be used at the trial site to quantify biochemically validated smoking abstinence (exhaled carbon monoxide levels above ten ppm regarded as indicator of current smoking). All secondary outcomes and self-reported usage of nicotine patches, EC and cigarettes will be monitored throughout the study. Information about self-reported smoking, usage of EC and nicotine patches, use of other smoking cessation therapy and side effects will be gathered at all follow-up calls and visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants who are eligible and consent to take part will be randomized (1:1 ratio) to receive products accordingly: A total of 258 participants will be enrolled (129 in each arm) and randomized to Study Arm A: 18 mg nicotine e-cigarettes (ad libitum use) for 12 weeks after the nominated quit date; and Study Arm B: 21 mg nicotine patches (one daily) for 12 weeks after the nominated quit date. The duration of counseling will be at least 30 minutes at site. The duration of counseling through telephone will be at least 10 minutes. Participants will be scheduled for a screening visit and a baseline (BL) visit at the trial site. The participants will be scheduled for eight study visits in total, including five treatment sessions and three follow-up visits, using both face to face interaction at trial site as well as follow up on telephone. Eight study visits are planned at weeks 1, 2, 4, 8, 12, 18, 24, and 52.
| Arm | Type | Receives |
|---|---|---|
| Study Arm A: Electronic Cigarettes (18mg/ml) | Active comparator | Device: E-CigaretteParticipants randomized to study arm A will be provided a free e-cigarette and sufficient nicotine cartridges (18 mg/ml) supply to last till next in person visit. Participants will be instructed to use the device ad libitum one week before their quit day to familiarize themselves with its operation and on their designated quit day will stop smoking tobacco cigarettes and instead use the e-cigarette exclusively for the next 12 weeks. Smokers often take 10 to 15 puffs over the course of 5 to 8 minutes, repeating this pattern with each cigarette. On the other hand, users of EC may periodically use it throughout the day, and they may or may not take their puffs like those of traditional cigarettes |
| Study Arm B: 21 mg nicotine patches | Active comparator | Drug: Nicotine patchParticipants randomized to study arm B will be provided 21 mg nicotine patches supply to last till next in person visit. Participants will use the nicotine patch daily for one week before their quit day to familiarize themselves with its use. On their designated quit day they will stop smoking and use nicotine patches daily for the next 12 weeks. Usually a full-strength patch (15-22 mg of nicotine) daily for four weeks is suggested for use in majority of the smokers, followed by a lower strength patch (5-14 mg of nicotine) for an additional four weeks, depending on their body size and smoking habits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Both genders of legal age allowed for smoking as per country law
- Smoked at least 10 cigarettes a day for the past one year
- Exhaled breath CO (eCO) level > 10 ppm
- Wish to quit smoking
- Able to conform with all study procedures
Key exclusion criteria (4 listed)
- Pregnant and breastfeeding women
- Using other smoking cessation medications (including other forms of NRT other than patch, bupropion, clonidine, nortriptyline or varenicline)
- Having any contraindications to products such as cardiovascular history
- Suffering from a major illness with prognosis of less than 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-CigaretteE-cigarettes have been designed to resemble tobacco cigarettes. They include an aerosol generator, sensor, battery and storage area for liquid. They are either disposable or rechargeable. According to a study, e-cigarettes can deliver an average of 1.3 mg (range 0.4 to 2.6 mg) of nicotine from 15 puffs. Average Cmax after e-cigarette use is recorded as 8.4 ng/mL and Tmax achieved between 2 to 5 minutes | Device | Study Arm A: Electronic Cigarettes (18mg/ml) |
| Nicotine patchAlso: PatchThe nicotine patches are applied on the skin and nicotine is delivered at a steady rate. After administration, the peak blood levels are achieved within 6-10 hours. The levels remain constant, reducing by 25-40% with use of patches once daily. The patch is typically administered every 24 hours for no longer than 12 weeks. The dose of the patches is often determined by daily cigarette consumption and level of addiction. | Drug | Study Arm B: 21 mg nicotine patches |
Primary outcome
Point-prevalence abstinence
Time frame: 12 weeks
Number of participants self-reported abstinence in the past week, with biochemical validation using exhaled CO measurements of ≤ 10 ppm.
5 secondary outcomes
Seven-day point prevalence
Time frame: 7 days for 12 weeks
Use of tobacco combustible cigarettes
Time frame: 12 weeks
Perception of the product
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Physical signs and symptoms associated with withdrawal
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madeeha Malik, PhD principal investigator
Cyntax Health Projects PVT LTD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing E-Cigarette and Nicotine patch in people with Smoking Cessation, run by Foundation for a Smoke Free World INC at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Madeeha Malik, PhD (+923325198527, madeehamalik19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point-prevalence abstinence (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.