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Self-directed Titrated Transdermal Nicotine Patch Versus Standard Treatment for Smoking Cessation (STEP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Andrew Pipe, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01622998
First received: June 15, 2012
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Drug: NicoDerm Patch
Drug: Nicorette Inhaler
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Self-directed Titrated Transdermal Nicotine Patch Versus Standard Treatment for Smoking Cessation in Smokers Motivated to Quit

Resource links provided by NLM:


Further study details as provided by Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • Validated continuous abstinence rate at week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Self-reported continuous abstinence at week 52 post target quit date will be confirmed with a carbon monoxide breath test.


Secondary Outcome Measures:
  • Validated continuous abstinence rates at weeks 10 and 26 weeks and seven day point prevalence of abstinence rates at weeks 10, 26 & 52 [ Time Frame: weeks 10, 26 and 52 ] [ Designated as safety issue: No ]

    Self-reported continuous abstinence rates will be validated with a carbon monoxide breath test at weeks 10 and 26 post target quit date.

    Self-reported seven day point prevalence of abstinence will be validated at week 10, 26 and 52 weeks post target quite date.



Estimated Enrollment: 1170
Study Start Date: January 2011
Estimated Study Completion Date: July 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard transdermal NRT group (UC)
10 week standard transdermal nicotine replacement therapy patch protocol
Drug: NicoDerm Patch

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.

Other Names:
  • Nicoderm 21mg, NPN: #02093146
  • Nicoderm 14mg, NPN: #02093138
  • Nicoderm 7mg, NPN: #02093111
Experimental: Titrated transdermal NRT group (EXP)
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.
Drug: NicoDerm Patch

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.

Other Names:
  • Nicoderm 21mg, NPN: #02093146
  • Nicoderm 14mg, NPN: #02093138
  • Nicoderm 7mg, NPN: #02093111
Drug: Nicorette Inhaler
Nicorette Inhaler: Box, 42 cartridges (4mg/cartridge) Dosage: Ad libitum Maximum dosage: 6-12 cartridges/day
Other Name: Nicorette Inahler, NPN: #02241742

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:

  1. 10-week standard treatment of transdermal nicotine replacement therapy (NRT);or
  2. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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;

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622998

Locations
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Andrew Pipe, CM, MD Ottawa Heart Institute Research Corporation
  More Information

Publications:
Responsible Party: Andrew Pipe, Chief, Division of Prevention and Rehabilitation, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT01622998     History of Changes
Other Study ID Numbers: NA7025
Study First Received: June 15, 2012
Last Updated: September 17, 2014
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Heart Institute Research Corporation:
Pharmacotherapy
Titration
Smoking Cessation

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014