Effectiveness of Oral Nicotine Pouches as a Cessation Tool Among Adult Tobacco Users in Pakistan
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCyntax Health Projects PVT LTD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Velo 6 mg Oral Nicotine Pouches
Other interventionParticipants 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 Counselling
BehavioralParticipants 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.
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: Velo Oral Nicotine Pouches Plus Motivational CounsellingExperimental treatment 2 interventions
Group B: Motivational Counselling AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
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 12Secondary outcomes
1
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 122
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 123
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 124
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 12Sponsors and contacts
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Source ClinicalTrials.gov
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