Smoking CessationPhase 4STEPNCT01622998
Self-directed Titrated Transdermal Nicotine Patch Versus Standard Treatment for Smoking Cessation
A Phase 4 study testing NicoDerm Patch and Nicorette Inhaler in people with Smoking Cessation, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
The primary aim of this research study is to determine whether titrated, patient-directed transdermal patch NRT, based on smoking history and symptoms of nicotine withdrawal, improves long-term rates of smoking cessation in patients motivated to quit smoking when compared to patients using the standard transdermal NRT… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- NicoDerm Patch and Nicorette Inhaler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Sep 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current smoker (≥ 10 cigarette per day);
- 18 years of age or older;
- Willing to set a date to quit smoking within the 30 days following the baseline assessment;
- Participant is willing to return to the UOHI for follow-up examination;
- Participant is willing to provide informed consent;
- Motivated to quit smoking.
Who cannot join
- Participant is unable to read and understand English or French;
- Participant is pregnant, lactating or planning to become pregnant during the study period;
- Participant has attempted to quit smoking in the previous month with the support of medication for >72 hours;
- Participant is currently using a smoking cessation medication (e.g., NRT, Bupropion, Varenicline,Clonadine, Notriptyline);
- Participant has contraindication(s) to nicotine replacement therapy (allergy to adhesive, life-threatening arrhythmias (e.g., tachycardia);
- Participant is during the immediate post-myocardial infarction period (i.e. incident has occurred within the last 10 days);
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- Severe or worsening angina pectoris;
- Subject has had a recent cerebral vascular accident (i.e. incident has occurred within the last 10 days);
- Participant currently suffering with depression (BDI-II ≥20);
- Participant who has been diagnosed with depression or treated with an antidepressant in the past 12 months;
- Past or present history of psychosis (Schizophrenia, Schizophreniform or Delusional Disorders),panic disorder, or bipolar disorder;
- Drug or alcohol abuse or dependence in the past year;
- Member of the participant's household is already participating in the study or in the "Quit Smoking in the 'Real World'" study;
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-directed Titrated Transdermal Nicotine Patch Versus Standard Treatment for Smoking Cessation in Smokers Motivated to Quit
The primary aim of this research study is to determine whether titrated, patient-directed transdermal patch NRT, based on smoking history and symptoms of nicotine withdrawal, improves long-term rates of smoking cessation in patients motivated to quit smoking when compared to patients using the standard transdermal NRT patch protocol. The following hypothesis will be tested: CO-validated continuous abstinence rate at 52 weeks post target quit date will be higher for the titrated, self-directed NRT group compared to the standard NRT treatment group.
Read the detailed description
Participants will be recruited from the UOHI Smoking Cessation Clinic and via media advertisements. Following their baseline assessment, participants will be randomly assigned to one of two groups:
- 10-week standard treatment of transdermal nicotine replacement therapy (NRT);or
- 10-week titrated transdermal nicotine replacement therapy (NRT) treatment with additional NRT product (NRT+)
Participants assigned to the "NRT" standard treatment group will follow a 10-week regimen of nicotine patches alone.
Participants assigned to the "NRT+" titrated treatment group will follow a 10-week regimen of tailored patch dosage. Participants will also be provided with the Nicorette inhaler.
All participants will receive five 15-minute counselling sessions from a smoking cessation counsellor. These sessions occur at 1, 3, 5, 8 and 10 weeks post target quit date. Counselling sessions will focus on practical counselling (problem solving and skills training) and social support.
During the treatment phase, participants will complete questionnaires measuring withdrawal symptoms, self-efficacy, use of cessation resources and the Beck Depression Inventory (BDI-II) at weeks 1, 3, 5, 8 and 10. These questionnaires will also be completed at 26 and 52 weeks post target quit date.
- Conditions
- Smoking Cessation
- Being tested
- NicoDerm Patch, Nicorette Inhaler
- Keywords
- Pharmacotherapy, Titration, Smoking Cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicoDerm PatchDrug
Also called Nicoderm 21mg, NPN: #02093146, Nicoderm 14mg, NPN: #02093138, Nicoderm 7mg, NPN: #02093111
Dosage: 21mg patch; 14mg patch; 7 mg patch Frequency: NRT patch application once per day Duration: 10 week treatment period
*Titration for experimental group (NRT+) based on smoking history, and option to increase dose if withdrawal symptoms are unmanageable.
Nicorette InhalerDrug
Also called Nicorette Inahler, NPN: #02241742
Nicorette Inhaler: Box, 42 cartridges (4mg/cartridge) Dosage: Ad libitum Maximum dosage: 6-12 cartridges/day
| Study group | Role | What they receive |
|---|---|---|
| Standard transdermal NRT group (UC) | Active comparator | 10 week standard transdermal nicotine replacement therapy patch protocol Receives: Drug: NicoDerm Patch |
| Titrated transdermal NRT group (EXP) | Experimental | 10 week titrated transdermal nicotine replacement therapy patch dose regimen based on smoking history with the option to increase dose, if withdrawal symptoms are unmanageable. Receives: Drug: NicoDerm Patch; Drug: Nicorette Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validated Continuous Abstinence Rate at Week 52
Self-reported continuous abstinence at week 52 post target quit date will be confirmed with a carbon monoxide breath test.
Measured: Week 52
Secondary outcomes (3)
Validated Continuous Abstinence Rates at Weeks 10 and 26 Weeks
Self-reported continuous abstinence rates will be validated with a carbon monoxide breath test at weeks 10 and 26 post target quit date.
Measured: weeks 10, 26
Self Reported 7-day Point Prevalence at Weeks 10, 26 and 52.
Measured: Self-reported seven day point prevalence of abstinence will be validated at week 10, 26 and 52 weeks post target quite date.
Self-reported Continuous Abstinence at Weeks 10, 26 and 52
Measured: Week 1 to 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startJan 2011
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Responsible party
- Sponsor
- Investigators
- Andrew Pipe, CM, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622998
- Sponsor's protocol ID
- NA7025
- Acronym
- STEP
- Status last verified
- Feb 2022
- First submitted
- 15 Jun 2012
- Last updated
- 14 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hughes JR, Keely J, Naud S. Shape of the relapse curve and long-term abstinence among untreated smokers. Addiction. 2004 Jan;99(1):29-38. doi: 10.1111/j.1360-0443.2004.00540.x.
PubMed 14678060Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009.
PubMed 18617085Slovinec D'Angelo ME, Reid RD, Hotz S, Irvine J, Segal RJ, Blanchard CM, Pipe A. Is stress management training a useful addition to physician advice and nicotine replacement therapy during smoking cessation in women? Results of a randomized trial. Am J Health Promot. 2005 Nov-Dec;20(2):127-34. doi: 10.4278/0890-1171-20.2.127.
PubMed 16295704Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.
PubMed 37335995
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-directed Titrated Transdermal Nicotine Patch Versus Standard Treatment for Smoking Cessation in Smokers Motivated to Quit
- ClinicalTrials.gov ID
- NCT01622998
- Acronym / sponsor ID
- STEP / NA7025
- Conditions
- Smoking Cessation
- Keywords
- Pharmacotherapy, Titration, Smoking Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Study start
- Jan 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Posted 14 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this research study is to determine whether titrated, patient-directed transdermal patch NRT, based on smoking history and symptoms of nicotine withdrawal, improves long-term rates of smoking cessation in patients motivated to quit smoking when compared to patients using the standard transdermal NRT patch protocol. The following hypothesis will be tested: CO-validated continuous abstinence rate at 52 weeks post target quit date will be higher for the titrated, self-directed NRT group compared to the standard NRT treatment group.
Detailed description
Participants will be recruited from the UOHI Smoking Cessation Clinic and via media advertisements. Following their baseline assessment, participants will be randomly assigned to one of two groups:
- 10-week standard treatment of transdermal nicotine replacement therapy (NRT);or
- 10-week titrated transdermal nicotine replacement therapy (NRT) treatment with additional NRT product (NRT+)
Participants assigned to the "NRT" standard treatment group will follow a 10-week regimen of nicotine patches alone.
Participants assigned to the "NRT+" titrated treatment group will follow a 10-week regimen of tailored patch dosage. Participants will also be provided with the Nicorette inhaler.
All participants will receive five 15-minute counselling sessions from a smoking cessation counsellor. These sessions occur at 1, 3, 5, 8 and 10 weeks post target quit date. Counselling sessions will focus on practical counselling (problem solving and skills training) and social support.
During the treatment phase, participants will complete questionnaires measuring withdrawal symptoms, self-efficacy, use of cessation resources and the Beck Depression Inventory (BDI-II) at weeks 1, 3, 5, 8 and 10. These questionnaires will also be completed at 26 and 52 weeks post target quit date.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard transdermal NRT group (UC) | Active comparator | Drug: NicoDerm Patch10 week standard transdermal nicotine replacement therapy patch protocol |
| Titrated transdermal NRT group (EXP) | Experimental | Drug: NicoDerm Patch, Drug: Nicorette Inhaler10 week titrated transdermal nicotine replacement therapy patch dose regimen based on smoking history with the option to increase dose, if withdrawal symptoms are unmanageable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Current smoker (≥ 10 cigarette per day);
- 18 years of age or older;
- Willing to set a date to quit smoking within the 30 days following the baseline assessment;
- Participant is willing to return to the UOHI for follow-up examination;
- Participant is willing to provide informed consent;
Key exclusion criteria (15 listed)
- Participant is unable to read and understand English or French;
- Participant is pregnant, lactating or planning to become pregnant during the study period;
- Participant has attempted to quit smoking in the previous month with the support of medication for >72 hours;
- Participant is currently using a smoking cessation medication (e.g., NRT, Bupropion, Varenicline,Clonadine, Notriptyline);
- Participant has contraindication(s) to nicotine replacement therapy (allergy to adhesive, life-threatening arrhythmias (e.g., tachycardia);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicoDerm PatchAlso: Nicoderm 21mg, NPN: #02093146, Nicoderm 14mg, NPN: #02093138, Nicoderm 7mg, NPN: #02093111Dosage: 21mg patch; 14mg patch; 7 mg patch Frequency: NRT patch application once per day Duration: 10 week treatment period *Titration for experimental group (NRT+) based on smoking history, and option to increase dose if withdrawal symptoms are unmanageable. | Drug | Standard transdermal NRT group (UC), Titrated transdermal NRT group (EXP) |
| Nicorette InhalerAlso: Nicorette Inahler, NPN: #02241742Nicorette Inhaler: Box, 42 cartridges (4mg/cartridge) Dosage: Ad libitum Maximum dosage: 6-12 cartridges/day | Drug | Titrated transdermal NRT group (EXP) |
Primary outcome
Validated Continuous Abstinence Rate at Week 52
Time frame: Week 52
Self-reported continuous abstinence at week 52 post target quit date will be confirmed with a carbon monoxide breath test.
3 secondary outcomes
Validated Continuous Abstinence Rates at Weeks 10 and 26 Weeks
Time frame: weeks 10, 26
Self Reported 7-day Point Prevalence at Weeks 10, 26 and 52.
Time frame: Self-reported seven day point prevalence of abstinence will be validated at week 10, 26 and 52 weeks post target quite date.
Self-reported Continuous Abstinence at Weeks 10, 26 and 52
Time frame: Week 1 to 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14678060Hughes JR, Keely J, Naud S. Shape of the relapse curve and long-term abstinence among untreated smokers. Addiction. 2004 Jan;99(1):29-38. doi: 10.1111/j.1360-0443.2004.00540.x.
- Background: PubMed 18617085Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009.
- Background: PubMed 16295704Slovinec D'Angelo ME, Reid RD, Hotz S, Irvine J, Segal RJ, Blanchard CM, Pipe A. Is stress management training a useful addition to physician advice and nicotine replacement therapy during smoking cessation in women? Results of a randomized trial. Am J Health Promot. 2005 Nov-Dec;20(2):127-34. doi: 10.4278/0890-1171-20.2.127.
- Derived from this study: PubMed 37335995Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Pipe, CM, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NicoDerm Patch and Nicorette Inhaler in people with Smoking Cessation, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validated Continuous Abstinence Rate at Week 52 (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01622998, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.