Trial Outcomes & Findings for STOP Study: Effectiveness of Zyban in a Clinical Population (NCT NCT01015170)
NCT ID: NCT01015170
Last Updated: 2017-03-27
Results Overview
Number of participants who report "Not Smoking (not even a puff) in past 7 days" when asked at week 8
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
454 participants
Primary outcome timeframe
End of Treatment (8 weeks after Zyban start date)
Results posted on
2017-03-27
Participant Flow
Participant milestones
| Measure |
Bupropion HCl
Up to 8 week of bupropion SR (150mg BID) + counseling.
bupropion HCl: 150mg BID for up to 8 weeks + counseling
|
|---|---|
|
Overall Study
STARTED
|
454
|
|
Overall Study
COMPLETED
|
215
|
|
Overall Study
NOT COMPLETED
|
239
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
STOP Study: Effectiveness of Zyban in a Clinical Population
Baseline characteristics by cohort
| Measure |
Buproprion & Behavioural Support
n=454 Participants
8 weeks of buproprion-SR + brief counselling for smoking cessation
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
415 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=39 Participants
|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 13.2 • n=39 Participants
|
|
Sex: Female, Male
Female
|
243 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
211 Participants
n=39 Participants
|
|
Education level attained
up to highschool
|
238 participants
n=39 Participants
|
|
Education level attained
Post secondary
|
207 participants
n=39 Participants
|
|
Education level attained
missing
|
9 participants
n=39 Participants
|
|
Employment
Employed
|
221 participants
n=39 Participants
|
|
Employment
Not employed
|
229 participants
n=39 Participants
|
|
Employment
missing
|
4 participants
n=39 Participants
|
|
Income category
up to $40,000
|
261 participants
n=39 Participants
|
|
Income category
more than $40,000
|
106 participants
n=39 Participants
|
|
Income category
missing
|
87 participants
n=39 Participants
|
|
Cigarettes per day (cpd)
|
20.5 # cigarettes smoked per day
STANDARD_DEVIATION 9.0 • n=39 Participants
|
|
Age first smoked
|
14.1 years
STANDARD_DEVIATION 3.7 • n=39 Participants
|
|
Age smoked daily
|
16.4 years
STANDARD_DEVIATION 4.3 • n=39 Participants
|
|
Time to first morning cigarette
15 minutes or less
|
306 participants
n=39 Participants
|
|
Time to first morning cigarette
more than 15 minutes
|
144 participants
n=39 Participants
|
|
Time to first morning cigarette
missing
|
4 participants
n=39 Participants
|
|
# quit attempts in the past
0 - 2 quit attempts
|
181 participants
n=39 Participants
|
|
# quit attempts in the past
3 or more quit attempts
|
225 participants
n=39 Participants
|
|
# quit attempts in the past
missing
|
48 participants
n=39 Participants
|
|
Importance of quitting smoking
|
9.2 units on a scale
STANDARD_DEVIATION 1.3 • n=39 Participants
|
|
Confidence in quitting smoking
|
7.6 units on a scale
STANDARD_DEVIATION 2.0 • n=39 Participants
|
|
Ever had a psychiatric diagnosis
No
|
309 participants
n=39 Participants
|
|
Ever had a psychiatric diagnosis
Yes
|
145 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: End of Treatment (8 weeks after Zyban start date)Population: Participants who completed survey 8 weeks after Zyban start date
Number of participants who report "Not Smoking (not even a puff) in past 7 days" when asked at week 8
Outcome measures
| Measure |
Nicotine Replacement & Behavioural Support
n=215 Participants
Nicotine Replacement Therapy: Transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge
\& Smoking cessation counselling-relapse prevention strategies.
|
|---|---|
|
7-day Point Prevalence of Smoking Abstinence
Still smoking
|
109 participants
|
|
7-day Point Prevalence of Smoking Abstinence
Quit smoking
|
106 participants
|
SECONDARY outcome
Timeframe: End of Treatment (8 weeks after Zyban start date)Population: This secondary outcome was not collected at 8 week followup.
Number of participants who report a serious quit attempt at End of treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months after Zyban start datePopulation: Number of participants who completed 6 month post treatment survey
Number of participants who report "Not Smoking (not even a puff) in past 7 days" when asked 6 months after Zyban start date
Outcome measures
| Measure |
Nicotine Replacement & Behavioural Support
n=448 Participants
Nicotine Replacement Therapy: Transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge
\& Smoking cessation counselling-relapse prevention strategies.
|
|---|---|
|
7-day Point Prevalence of Smoking Abstinence
Smoked in past 7 days
|
320 Participants
|
|
7-day Point Prevalence of Smoking Abstinence
Did not smoke in past 7 days
|
128 Participants
|
Adverse Events
Bupropion HCl
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bupropion HCl
n=454 participants at risk
Up to 8 week of bupropion SR (150mg BID) + counseling.
bupropion HCl: 150mg BID for up to 8 weeks + counseling
|
|---|---|
|
Injury, poisoning and procedural complications
head injury
|
0.22%
1/454 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
0.22%
1/454 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Mental Health issues
|
0.44%
2/454 • Number of events 2 • 1 year
|
|
Cardiac disorders
Chest pain
|
0.22%
1/454 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
0.22%
1/454 • Number of events 1 • 1 year
|
|
Nervous system disorders
Loss of consciousess
|
0.44%
2/454 • Number of events 2 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Peter Selby; Dr. Laurie Zawertailo Principal 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