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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: NicoDerm Patch; Drug: Nicorette Inhaler

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.

• Study Type: Interventional
• Enrollment (Actual): 303
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Nicorette Inahler, NPN: #02241742

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validated continuous abstinence rates at weeks 10 and 26 weeks and seven day point prevalence of abstinence rates at weeks 10, 26 & 52	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.	weeks 10, 26 and 52

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Collaborators: Heart and Stroke Foundation of Ontario
• Investigators: Principal Investigator: Andrew Pipe, CM, MD, Ottawa Heart Institute Research Corporation

Publications and helpful links

General Publications

• Slovinec 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.
• 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.
• Clinical 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: June 15, 2012
• First Submitted That Met QC Criteria: June 15, 2012
• First Posted (Estimate): June 19, 2012

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Smoking Cessation; Pharmacotherapy; Titration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: NA7025