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

NCT01622998 | Completed Phase 4 DMC

• 1 other identifier: NA7025
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

Pharmacotherapy; Titration; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Validated continuous abstinence rates at weeks 10 and 26 weeks and seven day point prevalence of abstinence rates at weeks 10, 26 & 52

  weeks 10, 26 and 52

Study Arms (2)

Standard transdermal NRT group (UC)

ACTIVE COMPARATOR

10 week standard transdermal nicotine replacement therapy patch protocol

Drug: NicoDerm Patch

Titrated transdermal NRT group (EXP)

EXPERIMENTAL

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; Drug: Nicorette Inhaler

Interventions

NicoDerm Patch DRUG

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.

Also known as: Nicoderm 21mg, NPN: #02093146, Nicoderm 14mg, NPN: #02093138, Nicoderm 7mg, NPN: #02093111

Standard transdermal NRT group (UC); Titrated transdermal NRT group (EXP)

Nicorette Inhaler DRUG

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

Also known as: Nicorette Inahler, NPN: #02241742

Titrated transdermal NRT group (EXP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current smoker (≥ 10 cigarette per day);
• years of age or older;
• Willing to set a date to quit smoking within the 30 days following the baseline assessment;
• Participant is willing to return to the UOHI for follow-up examination;
• Participant is willing to provide informed consent;
• Motivated to quit smoking.

You may not qualify if:

• Participant is unable to read and understand English or French;
• Participant is pregnant, lactating or planning to become pregnant during the study period;
• Participant has attempted to quit smoking in the previous month with the support of medication for \>72 hours;
• Participant is currently using a smoking cessation medication (e.g., NRT, Bupropion, Varenicline,Clonadine, Notriptyline);
• Participant has contraindication(s) to nicotine replacement therapy (allergy to adhesive, life-threatening arrhythmias (e.g., tachycardia);
• Participant is during the immediate post-myocardial infarction period (i.e. incident has occurred within the last 10 days);
• Severe or worsening angina pectoris;
• Subject has had a recent cerebral vascular accident (i.e. incident has occurred within the last 10 days);
• Participant currently suffering with depression (BDI-II ≥20);
• Participant who has been diagnosed with depression or treated with an antidepressant in the past 12 months;
• Past or present history of psychosis (Schizophrenia, Schizophreniform or Delusional Disorders),panic disorder, or bipolar disorder;
• Drug or alcohol abuse or dependence in the past year;
• Member of the participant's household is already participating in the study or in the "Quit Smoking in the 'Real World'" study;
• Participant is currently participating in or already receiving counseling or follow-up for smoking cessation.
• ) Participants who in the opinion of the investigator will be unlikely to commit to a year-long study;

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Heart and Stroke Foundation of Ontario: collaborator

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (4)

• 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.

  PMID: 14678060 BACKGROUND

• 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.

  PMID: 18617085 BACKGROUND

• 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.

  PMID: 16295704 BACKGROUND

• Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.

  PMID: 37335995 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Andrew Pipe, CM, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 19, 2012
• Study Start: January 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 10, 2022

Record last verified: 2022-02

Locations

CA (1)