Tobacco CessationNCT07785479
Effectiveness of Oral Nicotine Pouches as a Cessation Tool Among Adult Tobacco Users in Pakistan
A study testing Velo 6 mg Oral Nicotine Pouches and Motivational Counselling in people with Tobacco Cessation and Smoking Cessation, run by Cyntax Health Projects PVT LTD at 1 site in Pakistan.
Trial summary
Smoking remains a major public health challenge in Pakistan, where many adult smokers have limited access to effective smoking cessation support. This randomized controlled trial aims to evaluate whether combining oral nicotine pouches (Velo® 6 mg) with structured motivational counselling is more effective than… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tobacco Cessation, Smoking Cessation
- What is being tested?
- Velo 6 mg Oral Nicotine Pouches and Motivational Counselling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult smokers aged 18 to 65 years.
- Currently smoke 10 to 14 cigarettes per day.
- Express a willingness to quit smoking.
- Have no prior experience using oral nicotine pouches.
- Have no contraindications to nicotine use.
- Able and willing to provide written informed consent.
- Able and willing to comply with all study procedures and follow-up assessments.
Who cannot join
- Pregnant or breastfeeding women.
- Individuals with severe cardiovascular disease or other conditions that make nicotine use unsafe.
- Participants currently enrolled in another smoking cessation program or clinical trial.
- Individuals with known allergy or hypersensitivity to nicotine or any component of the oral nicotine pouches.
- Individuals with a history of significant psychiatric disorders that may interfere with study participation.
- Individuals unable or unwilling to comply with study procedures or follow-up visits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Trial to Assess the Effectiveness of Oral Nicotine Pouches as a Cessation Tool Among Adult Tobacco Users in Pakistan
Smoking remains a major public health challenge in Pakistan, where many adult smokers have limited access to effective smoking cessation support. This randomized controlled trial aims to evaluate whether combining oral nicotine pouches (Velo® 6 mg) with structured motivational counselling is more effective than motivational counselling alone in helping adult smokers quit smoking.
The study will enroll 148 adult smokers who smoke 10-14 cigarettes per day. Participants will be randomly assigned to one of two groups. One group will receive oral nicotine pouches together with motivational counselling, while the other group will receive motivational counselling only. The intervention will last for 12 weeks.
Read more
The main questions this study aims to answer are:
Does the combination of oral nicotine pouches and motivational counselling increase smoking cessation rates compared with motivational counselling alone? Does the intervention reduce cigarette cravings, withdrawal symptoms and the number of cigarettes smoked? Is the use of oral nicotine pouches safe, acceptable and well tolerated among adult smokers in Pakistan? How satisfied are participants with the treatment, and how well do they adhere to the intervention?
Participants will:
Be randomly assigned to receive either oral nicotine pouches plus motivational counselling or motivational counselling alone.
Attend study visits at baseline and at weeks 2, 4, 8 and 12. Undergo carbon monoxide breath testing to verify smoking status. Complete questionnaires on cigarette cravings, withdrawal symptoms, treatment satisfaction and adherence.
Report cigarette consumption and any side effects throughout the study.
The findings from this trial will provide evidence on the effectiveness, safety, and acceptability of oral nicotine pouches as a smoking cessation aid for adult tobacco users in Pakistan and may help inform future tobacco harm reduction and smoking cessation strategies.
Read the detailed description
This randomized controlled trial aims to evaluate the effectiveness of 6 mg Velo® oral nicotine pouches, available in Polar Mint and Berry Frost flavors, when combined with structured motivational counselling for smoking cessation among adult tobacco users in Pakistan. The study will compare this combined intervention with motivational counselling alone to determine whether ONPs improve smoking cessation outcomes.
Participants will be recruited from Premium Medical Complex, Rawalpindi. Eligible adult smokers who meet the inclusion criteria will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will receive oral nicotine pouches in addition to standardized motivational counselling, while participants in the control group will receive the same counselling program without nicotine pouches. The intervention period will last 12 weeks.
Throughout the study, participants will undergo regular clinical assessments to monitor smoking status, nicotine cravings, withdrawal symptoms, treatment adherence, participant satisfaction and safety. Smoking abstinence will be objectively verified using carbon monoxide breath testing in addition to participant self-report. Standardized and validated assessment tools will be used to evaluate craving intensity, withdrawal symptoms, treatment satisfaction and medication adherence.
Motivational counselling will be delivered using a structured, evidence-based approach incorporating motivational interviewing, goal setting, coping strategies, positive reinforcement and relapse prevention techniques. These counselling sessions are intended to enhance participants' motivation, strengthen self-efficacy, improve adherence to the intervention and support long-term smoking cessation.
Safety will be monitored throughout the trial by recording adverse events, monitoring vital signs, and documenting any nicotine-related side effects or product tolerability issues. Participant confidentiality will be maintained in accordance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines and the Declaration of Helsinki.
The findings of this study will provide the first randomized clinical evidence from Pakistan regarding the effectiveness, safety, adherence, and acceptability of oral nicotine pouches as a smoking cessation aid. The results are expected to inform future tobacco harm reduction policies, smoking cessation programs and clinical practice in Pakistan and other low- and middle-income countries with similar tobacco use patterns.
- Conditions
- Tobacco Cessation, Smoking Cessation
- Being tested
- Velo 6 mg Oral Nicotine Pouches, Motivational Counselling
- Keywords
- Oral Nicotine Pouches, Tobacco Harm Reduction, Smoking Cessation, Tobacco Cessation, Motivational Counselling, Behavioral Counselling, Pakistan
- Medical subject headings
- Tobacco Use Cessation, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Velo 6 mg Oral Nicotine PouchesOther
Participants receive commercially available 6 mg Velo oral nicotine pouches (Polar Mint or Berry Frost). The daily dose ranges from 1 to 3 pouches based on individual nicotine requirements, craving relief, withdrawal symptoms, tolerability and adherence during the 12-week intervention period.
Motivational CounsellingBehavioural
Participants receive structured group-based motivational counselling consisting of five sessions over 12 weeks. The counselling includes motivational interviewing, psychoeducation, SMART goal setting, coping strategies, stress management, positive reinforcement, peer support and relapse prevention to support smoking cessation.
| Study group | Role | What they receive |
|---|---|---|
| Velo Oral Nicotine Pouches Plus Motivational Counselling | Experimental | Participants receive 6 mg Velo oral nicotine pouches (Polar Mint or Berry Frost) together with structured motivational counselling for 12 weeks. Participants will use 1-3 oral nicotine pouches per day according to an individualized dosing schedule and attend counselling sessions at baseline and weeks 2, 4, 8 and 12. Receives: Other: Velo 6 mg Oral Nicotine Pouches; Behavioral: Motivational Counselling |
| Motivational Counselling Alone | Active comparator | Participants receive structured motivational counselling only for 12 weeks. Counselling sessions are delivered at baseline and weeks 2, 4, 8, and 12 using standardized motivational interviewing, goal setting, coping strategies, positive reinforcement, and relapse prevention techniques. Receives: Behavioral: Motivational Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically Verified Smoking Cessation Rate
The proportion of participants who achieve smoking cessation, verified by carbon monoxide (CO) breath testing together with self-reported abstinence. ≥30% of participants in the intervention group are expected to achieve biochemically verified smoking abstinence (carbon monoxide [CO] level <6 ppm) by Week 12, compared with ≤10% of participants in the control group.
Measured: 12 weeks
Reduction in Daily Cigarette Consumption
Change in the average number of cigarettes smoked per day from baseline to Week 12, based on participant self-report. Reduce cigarette consumption by ≥30% from baseline. The mean daily cigarette consumption is expected to decrease from approximately 15 cigarettes per day at baseline to ≤7 cigarettes per day by Week 12 in the oral nicotine pouch intervention group, compared with a ≤20% reduction in the motivational counselling-only control group.
Measured: Baseline to Week 12
Secondary outcomes (6)
Change in Cigarette Craving Intensity
Change in cigarette craving intensity from baseline, measured using the Visual Analogue Scale for Cigarette Craving. Participants rate their current craving for a cigarette on a scale ranging from 0 to 10, where 0 indicates no craving and 10 indicates the strongest possible craving. Higher scores indicate greater cigarette craving and therefore a worse outcome. Changes in craving scores will be compared between the oral nicotine pouch intervention group and the motivational counselling-only control group.
Measured: Baseline, Weeks 2, 4, 8, and 12
Change in Nicotine Withdrawal Symptoms
Change in nicotine withdrawal symptoms measured using the Minnesota Nicotine Withdrawal Scale (MNWS). The scale assesses the severity of nicotine withdrawal symptoms, with individual symptoms rated from 0 (not present) to 4 (severe). Item scores are summed to generate a total withdrawal symptom score. Higher scores indicate greater severity of nicotine withdrawal symptoms and therefore a worse outcome.
Measured: Weeks 2, 4, 8, and 12
Medication Adherence Report Scale Score
Treatment adherence assessed using the 5-item Medication Adherence Report Scale (MARS-5). Each item is rated on a 5-point response scale, producing a total score ranging from 5 to 25. Higher scores indicate greater medication adherence and therefore a better outcome.
Measured: Weeks 2, 4, 8, and 12
Treatment Satisfaction Assessed Using the Treatment Satisfaction Questionnaire for Medication Version 1.4
Treatment satisfaction will be assessed using the Treatment Satisfaction Questionnaire for Medication, Version 1.4 (TSQM-1.4). The questionnaire assesses treatment satisfaction across the domains of effectiveness, side effects, convenience, and global satisfaction. Domain scores are transformed to a scale ranging from 0 to 100, with higher scores indicating greater treatment satisfaction and therefore a better outcome.
Measured: Weeks 2, 4, 8, and 12
Incidence of Adverse Events
Number of participants experiencing treatment-emergent adverse events related to oral nicotine pouch use during the study.
Measured: Baseline to Week 12
Adherence to Assigned Oral Nicotine Pouch Use
Adherence to assigned oral nicotine pouch use will be assessed using participant-reported use records/diaries. Adherence will be calculated as the percentage of prescribed oral nicotine pouches used during the assessment period. The outcome will be reported as a percentage from 0% to 100%, with higher percentages indicating greater adherence.
Measured: Weeks 2, 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyntax Health Projects PVT LTD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madeeha Malik, Principal investigator, Cyntax Health Projects PVT LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785479
- Sponsor's protocol ID
- W8-016
- Status last verified
- Aug 2026
- First submitted
- 28 Jun 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Assess the Effectiveness of Oral Nicotine Pouches as a Cessation Tool Among Adult Tobacco Users in Pakistan
- ClinicalTrials.gov ID
- NCT07785479
- Acronym / sponsor ID
- W8-016
- Conditions
- Tobacco Cessation, Smoking Cessation
- Keywords
- Oral Nicotine Pouches, Tobacco Harm Reduction, Smoking Cessation, Tobacco Cessation, Motivational Counselling, Behavioral Counselling, Pakistan
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Cyntax Health Projects PVT LTDUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Aug 2026 (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.
Smoking remains a major public health challenge in Pakistan, where many adult smokers have limited access to effective smoking cessation support. This randomized controlled trial aims to evaluate whether combining oral nicotine pouches (Velo® 6 mg) with structured motivational counselling is more effective than motivational counselling alone in helping adult smokers quit smoking.
The study will enroll 148 adult smokers who smoke 10-14 cigarettes per day. Participants will be randomly assigned to one of two groups. One group will receive oral nicotine pouches together with motivational counselling, while the other group will receive motivational counselling only. The intervention will last for 12 weeks.
The main questions this study aims to answer are:
Does the combination of oral nicotine pouches and motivational counselling increase smoking cessation rates compared with motivational counselling alone? Does the intervention reduce cigarette cravings, withdrawal symptoms and the number of cigarettes smoked? Is the use of oral nicotine pouches safe, acceptable and well tolerated among adult smokers in Pakistan? How satisfied are participants with the treatment, and how well do they adhere to the intervention?
Participants will:
Be randomly assigned to receive either oral nicotine pouches plus motivational counselling or motivational counselling alone.
Attend study visits at baseline and at weeks 2, 4, 8 and 12. Undergo carbon monoxide breath testing to verify smoking status. Complete questionnaires on cigarette cravings, withdrawal symptoms, treatment satisfaction and adherence.
Report cigarette consumption and any side effects throughout the study.
The findings from this trial will provide evidence on the effectiveness, safety, and acceptability of oral nicotine pouches as a smoking cessation aid for adult tobacco users in Pakistan and may help inform future tobacco harm reduction and smoking cessation strategies.
Detailed description
This randomized controlled trial aims to evaluate the effectiveness of 6 mg Velo® oral nicotine pouches, available in Polar Mint and Berry Frost flavors, when combined with structured motivational counselling for smoking cessation among adult tobacco users in Pakistan. The study will compare this combined intervention with motivational counselling alone to determine whether ONPs improve smoking cessation outcomes.
Participants will be recruited from Premium Medical Complex, Rawalpindi. Eligible adult smokers who meet the inclusion criteria will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will receive oral nicotine pouches in addition to standardized motivational counselling, while participants in the control group will receive the same counselling program without nicotine pouches. The intervention period will last 12 weeks.
Throughout the study, participants will undergo regular clinical assessments to monitor smoking status, nicotine cravings, withdrawal symptoms, treatment adherence, participant satisfaction and safety. Smoking abstinence will be objectively verified using carbon monoxide breath testing in addition to participant self-report. Standardized and validated assessment tools will be used to evaluate craving intensity, withdrawal symptoms, treatment satisfaction and medication adherence.
Motivational counselling will be delivered using a structured, evidence-based approach incorporating motivational interviewing, goal setting, coping strategies, positive reinforcement and relapse prevention techniques. These counselling sessions are intended to enhance participants' motivation, strengthen self-efficacy, improve adherence to the intervention and support long-term smoking cessation.
Safety will be monitored throughout the trial by recording adverse events, monitoring vital signs, and documenting any nicotine-related side effects or product tolerability issues. Participant confidentiality will be maintained in accordance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines and the Declaration of Helsinki.
The findings of this study will provide the first randomized clinical evidence from Pakistan regarding the effectiveness, safety, adherence, and acceptability of oral nicotine pouches as a smoking cessation aid. The results are expected to inform future tobacco harm reduction policies, smoking cessation programs and clinical practice in Pakistan and other low- and middle-income countries with similar tobacco use patterns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Velo Oral Nicotine Pouches Plus Motivational Counselling | Experimental | Other: Velo 6 mg Oral Nicotine Pouches, Behavioral: Motivational CounsellingParticipants receive 6 mg Velo oral nicotine pouches (Polar Mint or Berry Frost) together with structured motivational counselling for 12 weeks. Participants will use 1-3 oral nicotine pouches per day according to an individualized dosing schedule and attend counselling sessions at baseline and weeks 2, 4, 8 and 12. |
| Motivational Counselling Alone | Active comparator | Behavioral: Motivational CounsellingParticipants receive structured motivational counselling only for 12 weeks. Counselling sessions are delivered at baseline and weeks 2, 4, 8, and 12 using standardized motivational interviewing, goal setting, coping strategies, positive reinforcement, and relapse prevention techniques. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult smokers aged 18 to 65 years.
- Currently smoke 10 to 14 cigarettes per day.
- Express a willingness to quit smoking.
- Have no prior experience using oral nicotine pouches.
- Have no contraindications to nicotine use.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women.
- Individuals with severe cardiovascular disease or other conditions that make nicotine use unsafe.
- Participants currently enrolled in another smoking cessation program or clinical trial.
- Individuals with known allergy or hypersensitivity to nicotine or any component of the oral nicotine pouches.
- Individuals with a history of significant psychiatric disorders that may interfere with study participation.
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 |
|---|---|---|
| Velo 6 mg Oral Nicotine PouchesParticipants receive commercially available 6 mg Velo oral nicotine pouches (Polar Mint or Berry Frost). The daily dose ranges from 1 to 3 pouches based on individual nicotine requirements, craving relief, withdrawal symptoms, tolerability and adherence during the 12-week intervention period. | Other | Velo Oral Nicotine Pouches Plus Motivational Counselling |
| Motivational CounsellingParticipants receive structured group-based motivational counselling consisting of five sessions over 12 weeks. The counselling includes motivational interviewing, psychoeducation, SMART goal setting, coping strategies, stress management, positive reinforcement, peer support and relapse prevention to support smoking cessation. | Behavioural | Motivational Counselling Alone, Velo Oral Nicotine Pouches Plus Motivational Counselling |
Primary outcome
Biochemically Verified Smoking Cessation Rate
Time frame: 12 weeks
The proportion of participants who achieve smoking cessation, verified by carbon monoxide (CO) breath testing together with self-reported abstinence. ≥30% of participants in the intervention group are expected to achieve biochemically verified smoking abstinence (carbon monoxide [CO] level <6 ppm) by Week 12, compared with ≤10% of participants in the control group.
Reduction in Daily Cigarette Consumption
Time frame: Baseline to Week 12
Change in the average number of cigarettes smoked per day from baseline to Week 12, based on participant self-report. Reduce cigarette consumption by ≥30% from baseline. The mean daily cigarette consumption is expected to decrease from approximately 15 cigarettes per day at baseline to ≤7 cigarettes per day by Week 12 in the oral nicotine pouch intervention group, compared with a ≤20% reduction in the motivational counselling-only control group.
6 secondary outcomes
Change in Cigarette Craving Intensity
Time frame: Baseline, Weeks 2, 4, 8, and 12
Change in Nicotine Withdrawal Symptoms
Time frame: Weeks 2, 4, 8, and 12
Medication Adherence Report Scale Score
Time frame: Weeks 2, 4, 8, and 12
Treatment Satisfaction Assessed Using the Treatment Satisfaction Questionnaire for Medication Version 1.4
Time frame: Weeks 2, 4, 8, and 12
Incidence of Adverse Events
Time frame: Baseline to Week 12
Adherence to Assigned Oral Nicotine Pouch Use
Time frame: Weeks 2, 4, 8, and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- 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.
Madeeha Malik 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 study testing Velo 6 mg Oral Nicotine Pouches and Motivational Counselling in people with Tobacco Cessation and Smoking Cessation, run by Cyntax Health Projects PVT LTD 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 6 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: opening soon, as of the sponsor's last update on 25 Aug 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically Verified Smoking Cessation Rate (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 25 Aug 2026.