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

Smoking Cessation Clinical Trial

— STEP  

Official title:

Self-directed Titrated Transdermal Nicotine Patch Versus Standard Treatment for Smoking Cessation in Smokers Motivated to Quit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622998
• Other study ID #: NA7025
• Status: Completed
• Phase: Phase 4
• Start date: January 2011
• Est. completion date: September 2014

Study information

• Verified date: February 2022
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.
• Nicorette Inhaler
Nicorette Inhaler: Box, 42 cartridges (4mg/cartridge) Dosage: Ad libitum Maximum dosage: 6-12 cartridges/day

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	Heart and Stroke Foundation of Ontario

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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