Trial Outcomes & Findings for Phase I Study: Stop Smoking Therapy for Ontario Patients (STOP) (NCT NCT00356993)
NCT ID: NCT00356993
Last Updated: 2021-11-30
Results Overview
7-day point prevalence of abstinence at 6 months post treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6009 participants
Primary outcome timeframe
6 months post treatment
Results posted on
2021-11-30
Participant Flow
Participant milestones
| Measure |
NRT + Behavioural Support
Nicotine Replacement Therapy plus Behavioural Intervention
Nicotine Replacement Therapy: transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge
behavioural intervention: Smoking cessation counselling, relapse prevention strategies
|
|---|---|
|
Overall Study
STARTED
|
6009
|
|
Overall Study
COMPLETED
|
2088
|
|
Overall Study
NOT COMPLETED
|
3921
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
missing data n=47
Baseline characteristics by cohort
| Measure |
NRT + Behavioural Support
n=6009 Participants
Nicotine Replacement Therapy plus Behavioural Intervention
Nicotine Replacement Therapy: transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge
behavioural intervention: Smoking cessation counselling, relapse prevention strategies
|
|---|---|
|
Confidence to Quit Smoking
3
|
138 Participants
n=5962 Participants • missing data n=47
|
|
Confidence to Quit Smoking
4
|
170 Participants
n=5962 Participants • missing data n=47
|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 11.9 • n=6000 Participants • missing information for 9 participants
|
|
Sex: Female, Male
Female
|
3201 Participants
n=6000 Participants • missing data n=9
|
|
Sex: Female, Male
Male
|
2799 Participants
n=6000 Participants • missing data n=9
|
|
Confidence to Quit Smoking
5
|
870 Participants
n=5962 Participants • missing data n=47
|
|
Confidence to Quit Smoking
6
|
506 Participants
n=5962 Participants • missing data n=47
|
|
Confidence to Quit Smoking
7
|
859 Participants
n=5962 Participants • missing data n=47
|
|
Confidence to Quit Smoking
8
|
1373 Participants
n=5962 Participants • missing data n=47
|
|
Cigarettes per day (cpd)
1-9 cigarettes
|
6 Participants
n=2088 Participants • missing information for 3921 participants
|
|
Cigarettes per day (cpd)
10-14 cigarettes
|
358 Participants
n=2088 Participants • missing information for 3921 participants
|
|
Cigarettes per day (cpd)
15-19 cigarettes
|
337 Participants
n=2088 Participants • missing information for 3921 participants
|
|
Cigarettes per day (cpd)
20-24 cigarettes
|
493 Participants
n=2088 Participants • missing information for 3921 participants
|
|
Cigarettes per day (cpd)
25+ cigarettes
|
888 Participants
n=2088 Participants • missing information for 3921 participants
|
|
Cigarettes per day (cpd)
No response
|
6 Participants
n=2088 Participants • missing information for 3921 participants
|
|
Age started to smoke daily
|
17.3 years
STANDARD_DEVIATION 4.8 • n=6009 Participants
|
|
Age first smoked
|
14.2 years
STANDARD_DEVIATION 5.1 • n=6009 Participants
|
|
Number of Quit Attempts in past year
0 quit attempt
|
3058 Participants
n=5764 Participants • Missing data n= 245
|
|
Number of Quit Attempts in past year
1 quit attempt
|
2328 Participants
n=5764 Participants • Missing data n= 245
|
|
Number of Quit Attempts in past year
2 quit attempts
|
378 Participants
n=5764 Participants • Missing data n= 245
|
|
Importance of Quitting
1-least important thing to do
|
22 Participants
n=5980 Participants • missing data n=29
|
|
Importance of Quitting
2
|
10 Participants
n=5980 Participants • missing data n=29
|
|
Importance of Quitting
3
|
13 Participants
n=5980 Participants • missing data n=29
|
|
Importance of Quitting
4
|
14 Participants
n=5980 Participants • missing data n=29
|
|
Importance of Quitting
5
|
70 Participants
n=5980 Participants • missing data n=29
|
|
Importance of Quitting
6
|
66 Participants
n=5980 Participants • missing data n=29
|
|
Importance of Quitting
7
|
217 Participants
n=5980 Participants • missing data n=29
|
|
Importance of Quitting
8
|
797 Participants
n=5980 Participants • missing data n=29
|
|
Importance of Quitting
9
|
802 Participants
n=5980 Participants • missing data n=29
|
|
Importance of Quitting
10- the most important thing to do
|
3969 Participants
n=5980 Participants • missing data n=29
|
|
Confidence to Quit Smoking
1- very little confidence
|
66 Participants
n=5962 Participants • missing data n=47
|
|
Confidence to Quit Smoking
2
|
95 Participants
n=5962 Participants • missing data n=47
|
|
Confidence to Quit Smoking
9
|
591 Participants
n=5962 Participants • missing data n=47
|
|
Confidence to Quit Smoking
10 -very confident
|
1294 Participants
n=5962 Participants • missing data n=47
|
|
Diagnosed with a psychiatric disorder
Yes- diagnosed with a psychiatric disorder
|
2447 Participants
n=6009 Participants
|
|
Diagnosed with a psychiatric disorder
not diagnosed or missing data
|
3562 Participants
n=6009 Participants
|
|
highest level of education attained
some primary school
|
94 Participants
n=5933 Participants • missing data n=76
|
|
highest level of education attained
Primary school
|
164 Participants
n=5933 Participants • missing data n=76
|
|
highest level of education attained
some high school
|
1235 Participants
n=5933 Participants • missing data n=76
|
|
highest level of education attained
high school diploma
|
1369 Participants
n=5933 Participants • missing data n=76
|
|
highest level of education attained
some college
|
853 Participants
n=5933 Participants • missing data n=76
|
|
highest level of education attained
College diploma
|
1269 Participants
n=5933 Participants • missing data n=76
|
|
highest level of education attained
Some university
|
404 Participants
n=5933 Participants • missing data n=76
|
|
highest level of education attained
University degree
|
545 Participants
n=5933 Participants • missing data n=76
|
PRIMARY outcome
Timeframe: 6 months post treatmentPopulation: Not every participant completed the 6mo and 12mo follow-up surveys
7-day point prevalence of abstinence at 6 months post treatment
Outcome measures
| Measure |
NRT + Behavioural Support
n=2088 Participants
Nicotine Replacement Therapy plus Behavioural Intervention
Nicotine Replacement Therapy: transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge
behavioural intervention: Smoking cessation counselling, relapse prevention strategies
|
|---|---|
|
Count of Participants Not Smoking
|
766 Participants
|
SECONDARY outcome
Timeframe: 12 months post treatmentPopulation: Not every participant completed the 12mo follow-up surveys
7-day point prevalence of abstinence at 12 months post treatment
Outcome measures
| Measure |
NRT + Behavioural Support
n=387 Participants
Nicotine Replacement Therapy plus Behavioural Intervention
Nicotine Replacement Therapy: transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge
behavioural intervention: Smoking cessation counselling, relapse prevention strategies
|
|---|---|
|
Count of Participants Not Smoking
|
147 Participants
|
Adverse Events
NRT + Behavioural Support
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place