Personalized nicotine patch dosing may boost quit rates
NCT ID NCT01622998
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.
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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 Hide 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.
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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