Role of Tobacco Harm Reduction in Smoking CessationEarly Phase 1NCT05715164
Electronic Cigarettes and Nicotine Pouches for Smoking Cessation
A Early Phase 1 study testing E-cigarettes device plus liquid, Nicotine Pouches and Basic care counseling about smoking cessation in people with Role of Tobacco Harm Reduction in Smoking Cessation and Efficiency and Efficacy of E-cigarettes and Nicotine Pouches, run by Alternative Research Initiative at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- 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
- What is being tested?
- E-cigarettes device plus liquid, Nicotine Pouches and Basic care counseling about smoking cessation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 sitePakistan
- Study dates
- Dec 2023to Apr 2025
- Phase
- Early Phase 1
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rawalpindi and Islamabad Centre
Rawalpindi, Punjab Province, 46000
Sarnawaz Salamat, Msc, sarnawaaz@gmail.com
Juniad Khan, Msc
About this study
Official title: 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.
Read more
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.
- 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
- Being tested
- E-cigarettes device plus liquid, Nicotine Pouches, Basic care counseling about smoking cessation
- Keywords
- E-cigarettes, Nicotine Replacement Therapy, Smoking Cessation, Tobacco Control, Tobacco Harm Reduction
- Medical subject headings
- Vaping, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-cigarettes device plus liquidDevice
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.
Nicotine PouchesDrug
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.
Basic care counseling about smoking cessationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| E-cigarettes device plus liquid | Experimental | The 200 participants will receive e-cigarettes along with basic care counseling for 48 weeks. Receives: Device: E-cigarettes device plus liquid |
| Nicotine Pouches | Experimental | The 200 participants will receive nicotine pouches along with basic care counseling for 48 weeks. Receives: Drug: Nicotine Pouches |
| Basic care counseling about smoking cessation | Active comparator | The 200 participants will receive basic care counseling for 48 weeks. Receives: Other: Basic care counseling about smoking cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 60 Weeks
Secondary outcomes (1)
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.
Measured: 60 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study startDec 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Role of Tobacco Harm Reduction in 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The baseline survey will help to evaluate the smoking status, smoking behavior, socio-demographic characteristics, health status, etc. The three-arm study design would randomize 600 participants into three groups. Of the 600 participants, 200 each will receive e-cigarettes, nicotine pouches, and basic care counseling respectively. 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, 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 or e-cigarettes. All participants will complete a follow-up survey at 60 weeks. The provision of e-cigarettes and nicotine pouches will be stopped after the first 48 weeks. The remaining 12 weeks will be without the provision of any intervention and the participants must buy these items on their own.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alternative Research Initiative
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for a Smoke Free World INC
- Responsible party
- Principal investigator, Dr Abdul Hameed, Alternative Research Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715164
- Sponsor's protocol ID
- P-0094
- Status last verified
- Feb 2023
- First submitted
- 9 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hameed A, Malik D. Clinical study protocol on electronic cigarettes and nicotine pouches for smoking cessation in Pakistan: a randomized controlled trial. Trials. 2024 Jan 2;25(1):9. doi: 10.1186/s13063-023-07876-y.
PubMed 38167206
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Cigarettes and Nicotine Pouches for Smoking Cessation in Pakistan: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05715164
- Acronym / sponsor ID
- P-0094
- 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
- Keywords
- E-cigarettes, Nicotine Replacement Therapy, Smoking Cessation, Tobacco Control, Tobacco Harm Reduction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Alternative Research InitiativeUniversity, hospital or other
- Collaborators
- Foundation for a Smoke Free World INC
- Study start
- Dec 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 6 Feb 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The baseline survey will help to evaluate the smoking status, smoking behavior, socio-demographic characteristics, health status, etc. The three-arm study design would randomize 600 participants into three groups. Of the 600 participants, 200 each will receive e-cigarettes, nicotine pouches, and basic care counseling respectively. 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, 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 or e-cigarettes. All participants will complete a follow-up survey at 60 weeks. The provision of e-cigarettes and nicotine pouches will be stopped after the first 48 weeks. The remaining 12 weeks will be without the provision of any intervention and the participants must buy these items on their own.
| Arm | Type | Receives |
|---|---|---|
| E-cigarettes device plus liquid | Experimental | Device: E-cigarettes device plus liquidThe 200 participants will receive e-cigarettes along with basic care counseling for 48 weeks. |
| Nicotine Pouches | Experimental | Drug: Nicotine PouchesThe 200 participants will receive nicotine pouches along with basic care counseling for 48 weeks. |
| Basic care counseling about smoking cessation | Active comparator | Other: Basic care counseling about smoking cessationThe 200 participants will receive basic care counseling for 48 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
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-cigarettes device plus liquidThe 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. | Device | E-cigarettes device plus liquid |
| Nicotine PouchesThe 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. | Drug | Nicotine Pouches |
| Basic care counseling about smoking cessationThe 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. | Other | Basic care counseling about smoking cessation |
Primary outcome
Number of participants reported adverse events of e-cigarettes or nicotine pouches
Time frame: 60 Weeks
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.
Change in the number of combustible cigarettes per day
Time frame: 60 Weeks
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.
Point-prevalence abstinence
Time frame: 60 Weeks
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).
1 secondary outcome
7-day point-prevalence abstinence and harm reduction
Time frame: 60 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Derived from this study: PubMed 38167206Hameed A, Malik D. Clinical study protocol on electronic cigarettes and nicotine pouches for smoking cessation in Pakistan: a randomized controlled trial. Trials. 2024 Jan 2;25(1):9. doi: 10.1186/s13063-023-07876-y.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing E-cigarettes device plus liquid, Nicotine Pouches and Basic care counseling about smoking cessation in people with Role of Tobacco Harm Reduction in Smoking Cessation and Efficiency and Efficacy of E-cigarettes and Nicotine Pouches, run by Alternative Research Initiative 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 5 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 6 Feb 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Abdul Hameed, PhD (+923315813713, hameedleghari@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants reported adverse events of e-cigarettes or nicotine pouches (time frame: 60 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05715164, which also lists 1 linked publication.
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 6 Feb 2023.