Clinical trial NCT01622998: Self-directed Titrated Transdermal Nicotine Patch Versus Standard Treatment for Smoking Cessation
Official title: Self-directed Titrated Transdermal Nicotine Patch Versus Standard Treatment for Smoking Cessation in Smokers Motivated to Quit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: Pharmacotherapy
Titration
Smoking Cessation
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2012-06-19
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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;

Primary outcomes:
measure: Validated continuous abstinence rate at week 52
timeFrame: Week 52
Secondary outcomes:
measure: Validated continuous abstinence rates at weeks 10 and 26 weeks and seven day point prevalence of abstinence rates at weeks 10, 26 & 52
timeFrame: weeks 10, 26 and 52
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Andrew Pipe, CM, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1111/j.1360-0443.2004.00540.x.
citation: 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.
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. doi: 10.4278/0890-1171-20.2.127.