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Personalized nicotine patch dosing may boost quit rates

NCT ID NCT01622998

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 14, 2026 · Last updated Aug 14, 2026

Summary

This trial tests whether letting smokers adjust their own nicotine patch dose—based on their smoking history and withdrawal symptoms—helps them stay smoke-free longer than the standard fixed-dose patch. Adult smokers who smoke at least 10 cigarettes a day and are motivated to quit will be assigned to either the flexible dosing approach or usual care, with follow-up over a year. The main goal is to see if the flexible approach leads to higher rates of continuous abstinence, confirmed by breath tests, at 52 weeks after quitting.

What this could mean

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

Active substance
transdermal nicotine patch (with optional dose adjustment) and nicotine inhaler as rescue
What this could lead to
If flexible, patient-directed nicotine patch dosing works better than the standard fixed dose, it could improve long-term quit rates for smokers.
What could go wrong
The trial is relatively small and relies on self-reported abstinence confirmed by breath tests; results may not apply to all smokers, and nicotine replacement can cause skin irritation or other side effects.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

303 people

The number who actually took part.

Start date

Jan 2011

Finished

Sep 2014

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

Accepted

You do not need to have the condition being studied to take part.

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. Current smoker (≥ 10 cigarette per day); 2. 18 years of age or older; 3. Willing to set a date to quit smoking within the 30 days following the baseline assessment; 4. Participant is willing to return to the UOHI for follow-up examination; 5. Participant is willing to provide informed consent; 6. Motivated to quit smoking. Exclusion Criteria: 1. Participant is unable to read and understand English or French; 2. Participant is pregnant, lactating or planning to become pregnant during the study period; 3. Participant has attempted to quit smoking in the previous month with the support of medication for \>72 hours; 4. Participant is currently using a smoking cessation medication (e.g., NRT, Bupropion, Varenicline,Clonadine, Notriptyline); 5. Participant has contraindication(s) to nicotine replacement therapy (allergy to adhesive, life-threatening arrhythmias (e.g., tachycardia); 6. Participant is during the immediate post-myocardial infarction period (i.e. incident has occurred within the last 10 days); 7. Severe or worsening angina pectoris; 8. Subject has had a recent cerebral vascular accident (i.e. incident has occurred within the last 10 days); 9. Participant currently suffering with depression (BDI-II ≥20); 10. Participant who has been diagnosed with depression or treated with an antidepressant in the past 12 months; 11. Past or present history of psychosis (Schizophrenia, Schizophreniform or Delusional Disorders),panic disorder, or bipolar disorder; 12. Drug or alcohol abuse or dependence in the past year; 13. Member of the participant's household is already participating in the study or in the "Quit Smoking in the 'Real World'" study; 14. Participant is currently participating in or already receiving counseling or follow-up for smoking cessation. 13.) Participants who in the opinion of the investigator will be unlikely to commit to a year-long study;

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Conditions

The condition(s) this trial relates to.

nicotine dependence Smoking Cessation

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

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