An interventional study of Velo 6 mg Oral Nicotine Pouches and Motivational Counselling in Tobacco Cessation and Smoking Cessation, sponsored by Cyntax Health Projects PVT LTD. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Cyntax Health Projects PVT LTD · Not applicable, Interventional, and Treatment
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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.
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.
276 studies on the registry are indexed under Tobacco Use Cessation; 45 are open to participants now.
This study's planned enrollment of 148 is below the median of 226 across 256 interventional studies indexed under Tobacco Use Cessation.
Browse Tobacco Use Cessation studies →This is the only study on the registry with Cyntax Health Projects PVT LTD as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Velo 6 mg Oral Nicotine Pouches · Behavioral: Motivational Counselling
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.
Behavioral: Motivational Counselling
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.
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.
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.
Time frame: 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.
Time frame: Baseline to Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Weeks 2, 4, 8, and 12
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Apr 2027, 7 months later.
Of 115 non-industry interventional studies with no phase under Tobacco Use Cessation, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 40. This study's planned 7 months is below that.
Counting every sponsor, half of 116 studies reached it within 24 months; a quarter within 15 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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