Phase I Study: Stop Smoking Therapy for Ontario Patients (STOP)

NCT00356993 | Completed Results

• 1 other identifier: 81/2005
• Study Type: interventional
• Target: 6,009
• Locations: 1 country
• Sites: 1

Brief Summary

20% of Ontarians smoke. There was a decline in smoking prevalence from 1995 but it has remained unchanged since 2002. This rate of smoking cessation 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 long term.The goal of this study is to evaluate the methods and effectiveness of providing nicotine replacement (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.

Conditions

Smoking

Keywords

nicotine replacement therapy; smoking cessation

Outcome Measures

Primary Outcomes (1)

• Count of Participants Not Smoking

  7-day point prevalence of abstinence at 6 months post treatment

  6 months post treatment

Secondary Outcomes (1)

• Count of Participants Not Smoking

  12 months post treatment

Study Arms (1)

NRT + Behavioural Support

EXPERIMENTAL

Nicotine Replacement Therapy plus Behavioural Intervention

Drug: Nicotine Replacement Therapy; Behavioral: behavioural intervention

Interventions

Nicotine Replacement Therapy DRUG

transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge

Also known as: transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge

NRT + Behavioural Support

behavioural intervention BEHAVIORAL

Smoking cessation counselling, relapse prevention strategies

NRT + Behavioural Support

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 Ontario residents
• Older than or equal to 18 years of age
• Current daily smokers who smoke \>10 cigarettes per day
• Smoked more than 100 cigarettes in their lifetime

You may not qualify if:

• Current treatment with Varenicline
• Allergic to adhesive
• Intolerant to Nicotine Replacement Therapy
• Medical contraindications

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Ontario Ministry of Health and Long Term Care: 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, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre
• click for more information on the study: The STOP (Stop Smoking Therapy for Ontario Patients) Study: The Effectiveness of Nicotine Replacement Therapy in Ontario Smokers.

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Nicotine Replacement Therapy; Tobacco Use Cessation Devices; Nicotine Chewing Gum; Nicotine

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Peter Selby
• Organization: Addictions Program

peter_selby@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: No
• Restrictive Agreement: No

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: Chief, Addictions Program

Study Record Dates

• First Submitted: July 25, 2006
• First Posted: July 27, 2006
• Study Start: October 1, 2005
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: November 30, 2021
• Results First Posted: May 2, 2019

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)