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

Sponsor
Cyntax Health Projects PVT LTD
Study ID
NCT07785479
Status
Not Yet Recruiting

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Conditions

  • Smoking Cessation
  • Tobacco Cessation

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Velo 6 mg Oral Nicotine Pouches — OTHER
    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.
  • Motivational Counselling — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Aug 25, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Apr 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
148 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Velo Oral Nicotine Pouches Plus Motivational Counselling
    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.
  • Active Comparator: Motivational Counselling Alone
    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.

Primary Outcome Measure

Biochemically Verified Smoking Cessation Rate [ Time Frame: 12 weeks ]

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