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

University of Ottawa Heart Institute

Status and phase: Completed; Phase 4

Conditions: Smoking Cessation

Treatments: Drug: NicoDerm Patch; Drug: Nicorette Inhaler

Study type: Interventional

Funder types: Other

Identifiers

NCT01622998

NA7025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 303 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

303 participants in 2 patient groups

Standard transdermal NRT group (UC)

Active Comparator group

Description:

10 week standard transdermal nicotine replacement therapy patch protocol

Treatment:

Drug: NicoDerm Patch

Titrated transdermal NRT group (EXP)

Experimental group

Description:

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.

Treatment:

Drug: Nicorette Inhaler

Drug: NicoDerm Patch