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New hope for hardcore smokers: E-Cigs and natural pills put to the test

NCT ID NCT07274475

Disease control Sponsor: Centre for Addiction and Mental Health 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test whether e-cigarettes or a natural supplement called cytisine can help people who smoke at least 5 cigarettes a day and haven't been able to quit with standard treatments like nicotine patches or counseling. Over 4 years, 6,000 participants will be randomly assigned to receive either an e-cigarette starter kit or a 28-day supply of cytisine. Researchers will track how many people use these options and whether they reduce their smoking or quit entirely.

What this could mean

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

Active substance
E-cigarette e-liquid and cytisine
What this could lead to
If successful, this could provide effective harm-reduction options for smokers who struggle to quit with standard methods, potentially reducing smoking-related diseases.
What could go wrong
This is a large but early-stage feasibility study, not a final test. E-cigarettes and cytisine may not help everyone quit, and long-term safety of e-cigarettes is still uncertain.

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 6,000 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

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 years and older

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: 1. Willingness to comply with all study procedures, for the full duration of the study period (12 months); 2. Age 18 years or older; 3. Currently smoking 5 or more cigarettes daily; and 4. Must have regular access to a phone and email to receive study communications and complete study monitoring. Exclusion Criteria: 1. Individuals who smoke only occasionally or have quit smoking prior to the 6-month follow-up; 2. Daily or almost daily users of e-cigarettes for the past 30 days; 3. Presence of medical or psychiatric conditions that may interfere with safe participation or compliance with the study protocol, including severe cardiovascular disorders, renal impairment or respiratory conditions; 4. Known allergy or hypersensitivity to any components of the e-cigarettes, e-liquids, or cytisine; 5. Pregnant or breastfeeding, or planning to become pregnant within the next 12 months; or 6. Current use of pharmacological smoking cessation aids or participation in other smoking cessation clinical trials.

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Conditions

The condition(s) this trial relates to.

Behavior, Addictive Harm Reduction nicotine dependence Smoking Cessation Tobacco Smoking Vaping

As listed by the trial registrant

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

Harm reduction Nicotine Tobacco smoking

How to take part

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

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.