Stop Smoking Therapy for Ontario Patients

NCT00352781 | Completed Results

• 1 other identifier: 064/2006
• Study Type: interventional
• Target: 1,767
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 2 million Ontarians are current smokers. While smoking rates have declined over the past 25 years, these rates have remained constant since 2002. The rate of smoking cessation in Ontario has not kept up with the rest of Canada. A new strategy is necessary to increase the number of smokers making quit attempts and to increase the odds of quitting over the long term. The overall goal of the Stop Smoking Therapy for Ontario Patients (STOP) Study is to evaluate the methods and effectiveness of providing nicotine replacement therapy (NRT) to Ontario smokers. The study will develop an evidence-based protocol for providing NRT, provide faculty development on combining pharmacotherapy with behavioural interventions and will provide an evaluation framework to inform future coverage models. The goal for this phase of the STOP study is to provide faculty development on combining pharmacotherapy with behavioural interventions. This will be achieved by partnering with Public Health Units across Ontario who have established smoking cessation clinics but do not have the finances in place to offer NRT to their clients at a subsidized rate or free of charge. Cost has been shown to be a significant barrier to the access and use of NRT in individuals trying to quit smoking. However, combining pharmacotherapy with behavioural interventions may be more effective than either alone. Therefore, we hypothesize that providing NRT free of charge to clients enrolled in a smoking cessation clinic will be more effective for smoking cessation than behavioural interventions alone.

Conditions

Smoking

Keywords

nicotine replacement therapy; smoking cessation

Outcome Measures

Primary Outcomes (1)

• Smoking Cessation

  7-day point prevalence of abstinence

  6 months after end of treatment

Secondary Outcomes (1)

• Smoking Cessation

  12 months after end of treatment

Study Arms (1)

Nicotine Replacement + Behaviour Therapy

EXPERIMENTAL

Nicotine Replacement Therapy as per monograph \& behavioural intervention

Drug: nicotine replacement therapy; Behavioral: behavioural intervention

Interventions

nicotine replacement therapy DRUG

nicotine transdermal patches as per product monograph

Also known as: Nicoderm

Nicotine Replacement + Behaviour Therapy

behavioural intervention BEHAVIORAL

Smoking cessation counselling and relapse prevention

Nicotine Replacement + Behaviour Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be current residents of Ontario.
• Older than or equal to 18 years of age.
• Current daily smokers who smoke 10 or more cigarettes per day for at least 3 months.
• Has smoked more than 100 cigarettes in their lifetime.

You may not qualify if:

• Varenicline treatment, current.
• Intolerant to nicotine replacement therapy (NRT)
• Have a medical condition that would make participation medically hazardous as determined by the list of contraindications for NRT outlined in the Compendium of Pharmaceuticals and Specialties (CPS) and the NRT package insert, including a heart attack in the past two (2) weeks, life-threatening arrhythmias, severe or worsening angina pectoris, recent cerebro-vascular incident (past two (2) weeks)

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Ontario Ministry of Health and Long Term Care: collaborator
• Pfizer: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Links

• Information about research at the Centre for Addiction and Mental Health

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Nicotine Replacement Therapy; Nicotine

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Many participants could not be reached 6 and 12 months after treatment to complete the follow-up questionnaires. Data pertaining to smoker and provider satisfaction and healthcare utilization were not collected.

Results Point of Contact

• Title: Co-Investigator
• Organization: Centre for Addiction and Mental Health

laurie_zawertailo@camh.net

416-535-8501

Study Officials

• Peter Selby, MD, MHSc

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director, Addictions Program

Study Record Dates

• First Submitted: July 13, 2006
• First Posted: July 17, 2006
• Study Start: July 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 28, 2017
• Results First Posted: April 17, 2012

Record last verified: 2017-12

Locations

CA (1)