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

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 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.

Conditions

• Tobacco Cessation
• Smoking Cessation

Interventions

OTHER

Velo 6 mg Oral Nicotine Pouches

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.

BEHAVIORAL

Motivational Counselling

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.

Sponsors & Collaborators

• Cyntax Health Projects PVT LTD

  lead OTHER

Principal Investigators

• Madeeha Malik · Cyntax Health Projects PVT LTD

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-04-30

Completion

2027-06-30

Countries

• Pakistan

Study Locations