Trial Outcomes & Findings for Efficacy and Cost-Effectiveness of Cost-free Pharmacotherapy for Smoking Cessation for High-risk Smokers With Cerebrovascular Disease (NCT NCT00962988)
NCT ID: NCT00962988
Last Updated: 2026-08-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
194 participants
Primary outcome timeframe
52 weeks
Results posted on
2026-08-10
Participant Flow
Participant milestones
| Measure |
Cost-Free Group
Participants were provided a 12-week supply of cessation medication.
|
Prescription Only Group
Participants were provided with a prescription for cessation medication to be gilled at a pharmacy at their own cost.
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
95
|
|
Overall Study
Analyzed
|
97
|
93
|
|
Overall Study
COMPLETED
|
68
|
52
|
|
Overall Study
NOT COMPLETED
|
31
|
43
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total
n=194 Participants
Total of all reporting groups
|
Cost-Free Group
n=99 Participants
Participants were provided a 12-week supply of cessation medication.
|
Prescription Only Group
n=95 Participants
Participants were provided with a prescription for cessation medication to be gilled at a pharmacy at their own cost.
|
|---|---|---|---|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 10.2 • n=194 Participants
|
55.5 years
STANDARD_DEVIATION 9.7 • n=99 Participants
|
56.7 years
STANDARD_DEVIATION 10.7 • n=95 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=194 Participants
|
49 Participants
n=99 Participants
|
39 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=194 Participants
|
50 Participants
n=99 Participants
|
56 Participants
n=95 Participants
|
|
Race and Ethnicity Not Collected
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
—
|
—
|
|
Years of formal education
|
12.1 Years
STANDARD_DEVIATION 2.5 • n=194 Participants
|
12.1 Years
STANDARD_DEVIATION 2.6 • n=99 Participants
|
12.1 Years
STANDARD_DEVIATION 2.4 • n=95 Participants
|
|
Body Mass Index
|
27.7 kg/m^2
STANDARD_DEVIATION 6.0 • n=194 Participants
|
27.4 kg/m^2
STANDARD_DEVIATION 5.7 • n=99 Participants
|
28.1 kg/m^2
STANDARD_DEVIATION 6.3 • n=95 Participants
|
|
Reason for stroke prevention clinic referral
Trans-ischemic attack
|
91 Participants
n=194 Participants
|
45 Participants
n=99 Participants
|
46 Participants
n=95 Participants
|
|
Reason for stroke prevention clinic referral
Stroke
|
103 Participants
n=194 Participants
|
54 Participants
n=99 Participants
|
49 Participants
n=95 Participants
|
|
History of depression
|
59 Participants
n=194 Participants
|
28 Participants
n=99 Participants
|
31 Participants
n=95 Participants
|
|
History of Diabetes
|
56 Participants
n=194 Participants
|
34 Participants
n=99 Participants
|
22 Participants
n=95 Participants
|
|
Years smoked
|
36.3 years
STANDARD_DEVIATION 11.9 • n=194 Participants
|
35.5 years
STANDARD_DEVIATION 10.9 • n=99 Participants
|
37.1 years
STANDARD_DEVIATION 12.8 • n=95 Participants
|
|
Cigarettes per day
|
17.2 cigarettes per day
STANDARD_DEVIATION 9.3 • n=194 Participants
|
17.9 cigarettes per day
STANDARD_DEVIATION 10.7 • n=99 Participants
|
16.5 cigarettes per day
STANDARD_DEVIATION 7.5 • n=95 Participants
|
|
Fagerstrom nicotine dependence score
|
4.55 score
STANDARD_DEVIATION 2.2 • n=194 Participants
|
4.6 score
STANDARD_DEVIATION 2.2 • n=99 Participants
|
4.5 score
STANDARD_DEVIATION 2.2 • n=95 Participants
|
|
Quit attempts in past year
|
1.35 Number of quit attempts
STANDARD_DEVIATION 1.95 • n=194 Participants
|
1.3 Number of quit attempts
STANDARD_DEVIATION 2.0 • n=99 Participants
|
1.4 Number of quit attempts
STANDARD_DEVIATION 1.9 • n=95 Participants
|
|
Importance of quitting smoking scale
|
4.5 score
STANDARD_DEVIATION 0.95 • n=194 Participants
|
4.4 score
STANDARD_DEVIATION 1.0 • n=99 Participants
|
4.6 score
STANDARD_DEVIATION 0.9 • n=95 Participants
|
|
Confidence in ability to quit smoking scale
|
3.35 Score
STANDARD_DEVIATION 1.3 • n=194 Participants
|
3.4 Score
STANDARD_DEVIATION 1.2 • n=99 Participants
|
3.3 Score
STANDARD_DEVIATION 1.4 • n=95 Participants
|
|
Has insurance coverage for cessation medication
|
40 Participants
n=194 Participants
|
20 Participants
n=99 Participants
|
20 Participants
n=95 Participants
|
PRIMARY outcome
Timeframe: 52 weeksOutcome measures
| Measure |
Cost-Free Group
n=97 Participants
Participants were provided a 12-week supply of cessation medication.
|
Prescription Only Group
n=93 Participants
Participants were provided with a prescription for cessation medication to be gilled at a pharmacy at their own cost.
|
|---|---|---|
|
Biochemically Confirmed (Exhaled CO < 10 Ppm) of Self-reported Continuous Abstinence From Weeks 12 to 52 Following the Target Quit Date.
|
15 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 26 weeksOutcome measures
| Measure |
Cost-Free Group
n=97 Participants
Participants were provided a 12-week supply of cessation medication.
|
Prescription Only Group
n=93 Participants
Participants were provided with a prescription for cessation medication to be gilled at a pharmacy at their own cost.
|
|---|---|---|
|
Biochemically Confirmed (Exhaled CO < 10 Ppm) of Self-reported Continuous Abstinence From Weeks 12 to 26 Following the Target Quit Date.
|
18 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Cost-Free Group
n=97 Participants
Participants were provided a 12-week supply of cessation medication.
|
Prescription Only Group
n=93 Participants
Participants were provided with a prescription for cessation medication to be gilled at a pharmacy at their own cost.
|
|---|---|---|
|
Self-reported 7-day Point Prevalence Abstinence at 12 Week Followup
|
37 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 26 weeksOutcome measures
| Measure |
Cost-Free Group
n=97 Participants
Participants were provided a 12-week supply of cessation medication.
|
Prescription Only Group
n=93 Participants
Participants were provided with a prescription for cessation medication to be gilled at a pharmacy at their own cost.
|
|---|---|---|
|
Verified 7-day Point Prevalence Abstinence at 26 Week Follow-up
|
21 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 52 weeksOutcome measures
| Measure |
Cost-Free Group
n=97 Participants
Participants were provided a 12-week supply of cessation medication.
|
Prescription Only Group
n=93 Participants
Participants were provided with a prescription for cessation medication to be gilled at a pharmacy at their own cost.
|
|---|---|---|
|
Verified 7-day Point Prevalence Abstinence at 52 Week Follow-up
|
22 Participants
|
16 Participants
|
Adverse Events
Cost-Free Group
Serious events: 10 serious events
Other events: 0 other events
Deaths: 1 deaths
Prescription Only Group
Serious events: 12 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cost-Free Group
n=99 participants at risk
Participants were provided a 12-week supply of cessation medication.
|
Prescription Only Group
n=95 participants at risk
Participants were provided with a prescription for cessation medication to be gilled at a pharmacy at their own cost.
|
|---|---|---|
|
General disorders
Death
|
1.0%
1/99 • Baseline to 52 weeks
|
1.1%
1/95 • Baseline to 52 weeks
|
|
General disorders
Stroke, worsening stroke, or trans ischemic attack
|
2.0%
2/99 • Baseline to 52 weeks
|
2.1%
2/95 • Baseline to 52 weeks
|
|
General disorders
Carotid endarterectomy
|
1.0%
1/99 • Baseline to 52 weeks
|
1.1%
1/95 • Baseline to 52 weeks
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/99 • Baseline to 52 weeks
|
0.00%
0/95 • Baseline to 52 weeks
|
|
Cardiac disorders
Angina (Stable or Unstable)
|
0.00%
0/99 • Baseline to 52 weeks
|
1.1%
1/95 • Baseline to 52 weeks
|
|
Cardiac disorders
Cardiac revascularization
|
3.0%
3/99 • Baseline to 52 weeks
|
2.1%
2/95 • Baseline to 52 weeks
|
|
Cardiac disorders
Implantable cardioverter-defibrillator insertion
|
1.0%
1/99 • Baseline to 52 weeks
|
0.00%
0/95 • Baseline to 52 weeks
|
|
General disorders
Deep vein thrombosis
|
1.0%
1/99 • Baseline to 52 weeks
|
1.1%
1/95 • Baseline to 52 weeks
|
|
General disorders
Other, requiring hospitalization
|
6.1%
6/99 • Baseline to 52 weeks
|
8.4%
8/95 • Baseline to 52 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place