NCT00352781: STOP

The STOP (Stop Smoking Therapy for Ontario Patients) Study: The Effectiveness of Nicotine Replacement Therapy in Ontario Smokers PHASE II

Completed NA Results posted Last updated 4 December 2017

What this trial tests

NA trial testing nicotine replacement therapy in Smoking in 1,767 participants. Completed in 1 August 2009.

Timeline

1 July 2006

Primary endpoint
1 January 2009

1 August 2009

Quick facts

Lead sponsor	Centre for Addiction and Mental Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1,767
Start date	1 July 2006
Primary completion	1 January 2009
Estimated completion	1 August 2009
Sites	1 location across Canada

Drugs / interventions tested

• nicotine replacement therapy — full drug profile →
• behavioural intervention

Conditions studied

• Smoking — all drugs for Smoking →

Sponsor

Centre for Addiction and Mental Health — full company profile →

Who can join

18 and older, any sex, with Smoking. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Smoking Cessation
  Time frame: 6 months after end of treatment
  7-day point prevalence of abstinence

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.