Trial Outcomes & Findings for Stop Smoking Therapy for Ontario Patients (NCT NCT00352781)

Results Overview

7-day point prevalence of abstinence

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1767 participants

Primary outcome timeframe

6 months after end of treatment

Results posted on

2017-12-28

Participant Flow

Participants were recruited by their local public health unit.

Participant milestones

Participant milestones
Measure	Nicotine Replacement Therapy + Counseling Up to 10 weeks of open-label nicotine replacement therapy (as per product monograph) + counseling
Overall Study STARTED	1767
Overall Study COMPLETED	884
Overall Study NOT COMPLETED	883

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stop Smoking Therapy for Ontario Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nicotine Replacement Therapy (NRT) n=1767 Participants Open-label Nicotine Replacement Therapy + counseling
Age, Categorical <=18 years	7 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1654 Participants n=93 Participants
Age, Categorical >=65 years	106 Participants n=93 Participants
Age, Continuous	45.0 years STANDARD_DEVIATION 12.7 • n=93 Participants
Sex: Female, Male Female	997 Participants n=93 Participants
Sex: Female, Male Male	770 Participants n=93 Participants
Region of Enrollment Canada	1767 participants n=93 Participants

PRIMARY outcome

Timeframe: 6 months after end of treatment

Population: Number of participants that completed the 6m follow-up (i.e. per protocol)

7-day point prevalence of abstinence

Outcome measures

Outcome measures
Measure	Nicotine Replacement Therapy n=395 Participants Open-label nicotine replacement therapy (as per product monograph) plus counseling
Smoking Cessation	29 percentage of participants abstinent

SECONDARY outcome

Timeframe: 12 months after end of treatment

Population: Number of participants who completed the 12m follow-up

7-day point prevalence of abstinence

Outcome measures

Outcome measures
Measure	Nicotine Replacement Therapy n=442 Participants Open-label nicotine replacement therapy (as per product monograph) plus counseling
Smoking Cessation	26 percentage of participants abstinent

Adverse Events

Nicotine Replacement Therapy + Counseling

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nicotine Replacement Therapy + Counseling n=1767 participants at risk Up to 10 weeks of open-label nicotine replacement therapy + counseling
Cardiac disorders myocardial infarction	0.06% 1/1767 • Number of events 1
Nervous system disorders seizure	0.06% 1/1767 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Co-Investigator

Centre for Addiction and Mental Health

Phone: 416-535-8501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place