Effectiveness of Oral Nicotine Pouches as a Cessation Tool Among Adult Tobacco Users in Pakistan

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.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.