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Can nicotine pouches help smokers quit?

NCT ID NCT07785479

Disease control Sponsor: Cyntax Health Projects PVT LTD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial tests whether oral nicotine pouches, when combined with motivational counselling, can help adult smokers quit more effectively than counselling alone. About 148 smokers who smoke 10-14 cigarettes a day will be randomly assigned to receive either the pouches plus counselling or counselling only for 12 weeks. The study will measure quit rates, cravings, and safety to see if this approach is a viable cessation tool.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oral nicotine pouches (Velo 6 mg) combined with motivational counselling
What this could lead to
If effective, this combination could offer a practical, accessible smoking cessation aid for adult smokers in Pakistan and similar settings.
What could go wrong
The trial is relatively small and early-stage, and results may not generalize. Nicotine pouches carry risks like addiction and side effects, and success depends on adherence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 148 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

nicotine dependence Smoking Cessation Tobacco Use Cessation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Smoking cessation Tobacco cessation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Premium Medical Complex

    Rawalpindi, Punjab Province, 46000, Pakistan

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