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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ottawa Heart Institute Research Corporation
• Collaborator: Heart and Stroke Foundation of Ontario
• Treatments: Nicotine

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;