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

Overview

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.