Trial Outcomes & Findings for Effect of Paroxetine on Smokers' Cardiovascular Response to Stress - 1 (NCT NCT00218439)
NCT ID: NCT00218439
Last Updated: 2019-11-01
Results Overview
Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
After 4 weeks of paroxetine / placebo
Results posted on
2019-11-01
Participant Flow
Participant milestones
| Measure |
Placebo (4 Weeks) Then Paroxetine (4 Weeks)
Placebo once daily in first intervention period and Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of second intervention period
|
Paroxetine (4 Weeks) the Placebo (4 Weeks)
Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of first intervention period, placebo once daily in second intervention period
|
|---|---|---|
|
First Intervention (4 Weeks)
STARTED
|
58
|
47
|
|
First Intervention (4 Weeks)
COMPLETED
|
40
|
35
|
|
First Intervention (4 Weeks)
NOT COMPLETED
|
18
|
12
|
|
Second Intervention (4 Weeks)
STARTED
|
40
|
35
|
|
Second Intervention (4 Weeks)
COMPLETED
|
33
|
30
|
|
Second Intervention (4 Weeks)
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Paroxetine on Smokers' Cardiovascular Response to Stress - 1
Baseline characteristics by cohort
| Measure |
Placebo First 4 Weeks, Then Paroxetine for 4 Weeks
n=33 Participants
Placebo once daily in first intervention period and Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of second intervention period
|
Paroxetine First 4 Weeks, Then Placebo for 4 Weeks
n=29 Participants
Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of first intervention period, placebo once daily in second intervention period
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40.4 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
40.0 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
40.2 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
29 participants
n=7 Participants
|
62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 4 weeks of paroxetine / placeboChange in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette
Outcome measures
| Measure |
After 4 Weeks of Placebo
n=62 Participants
Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
|
After 4 Weeks of Paroxetine
n=62 Participants
Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
|
|---|---|---|
|
Systolic Blood Pressure Response to Stress
|
16.85 mmHg
Standard Error 0.78
|
11.71 mmHg
Standard Error 0.78
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After 4 weeks of paroxetine / placeboChange in diastolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette
Outcome measures
| Measure |
After 4 Weeks of Placebo
n=62 Participants
Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
|
After 4 Weeks of Paroxetine
n=62 Participants
Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
|
|---|---|---|
|
Diastolic Blood Pressure Response to Stress
|
9.78 mm Hg
Standard Error 0.49
|
8.07 mm Hg
Standard Error 0.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After 4 weeks of paroxetine / placeboChange in heart rate from Resting period to that observed during a speech delivered immediately after smoking a cigarette
Outcome measures
| Measure |
After 4 Weeks of Placebo
n=62 Participants
Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
|
After 4 Weeks of Paroxetine
n=62 Participants
Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
|
|---|---|---|
|
Heart Rate Response to Stress
|
20.39 beats/minute
Standard Error 0.56
|
20.02 beats/minute
Standard Error 0.56
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After 4 weeks of paroxetine / placeboChange in plasma epinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette
Outcome measures
| Measure |
After 4 Weeks of Placebo
n=62 Participants
Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
|
After 4 Weeks of Paroxetine
n=62 Participants
Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
|
|---|---|---|
|
Plasma Epinephrine Concentration Response to Stress
|
40.98 pg / ml
Standard Error 3.42
|
34.94 pg / ml
Standard Error 3.48
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After 4 weeks of paroxetine / placeboChange in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette
Outcome measures
| Measure |
After 4 Weeks of Placebo
n=62 Participants
Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
|
After 4 Weeks of Paroxetine
n=62 Participants
Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
|
|---|---|---|
|
Plasma Norepinephrine Concentration Response to Stress
|
72.31 pg / ml
Standard Error 18.32
|
63.37 pg / ml
Standard Error 18.32
|
Adverse Events
During 4 Weeks of Placebo
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
During 4 Weeks of Paroxetine
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
During 4 Weeks of Placebo
n=62 participants at risk
Participants receive placebo daily for 4 weeks
|
During 4 Weeks of Paroxetine
n=62 participants at risk
Participants received paroxetine 10 mg once daily for 1 week followed by 20 mg once daily for 3 weeks
|
|---|---|---|
|
General disorders
Dizziness
|
1.6%
1/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
9.7%
6/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
|
Gastrointestinal disorders
Gastrointenstinal symptoms
|
11.3%
7/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
21.0%
13/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
|
General disorders
drowsiness
|
16.1%
10/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
25.8%
16/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
|
Reproductive system and breast disorders
sexual side effects
|
1.6%
1/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
8.1%
5/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
|
General disorders
insomnia
|
4.8%
3/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
6.5%
4/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
|
General disorders
dry mouth / taste changes
|
1.6%
1/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
9.7%
6/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
|
General disorders
headache
|
1.6%
1/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
6.5%
4/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
|
Gastrointestinal disorders
change in appetite
|
8.1%
5/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
4.8%
3/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
|
General disorders
unusual dreams
|
8.1%
5/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
0.00%
0/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
|
General disorders
anxiety / irritability
|
12.9%
8/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
4.8%
3/62 • Adverse events data collected during treatment (i.e. 4 weeks of paroxetine or 4 weeks of placebo)
Subjects were asked at each visit an open ended question if they've experienced any side effects
|
Additional Information
Dr. Michael Kotlyar
University of Minnesota College of Pharmacy
Phone: 612-625-1160
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place