Trial · NCT00218439
Effect of Paroxetine on Smokers' Cardiovascular Response to Stress - 1
NCT00218439, Not applicable, Completed, University of Minnesota; results first posted 2014-05-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Paroxetine on Smokers' Cardiovascular Response to Stress - 1. Trials, record NCT00218439. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00218439
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Paroxetine on Smokers' Cardiovascular Response to Stress - 1
- NCT number
- NCT00218439
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 105 participants, actual
- Lead sponsor
- University of Minnesota
- Conditions
- Tobacco Use Disorder
- Interventions
- Paroxetine, Placebo
- First posted
- 2005-09-22
- Last updated
- 2019-11-01
- Results first posted
- 2014-05-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Systolic Blood Pressure Response to Stress | After 4 weeks of paroxetine / placebo | Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette |
| Other | Diastolic Blood Pressure Response to Stress | After 4 weeks of paroxetine / placebo | Change in diastolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette |
| Other | Heart Rate Response to Stress | After 4 weeks of paroxetine / placebo | Change in heart rate from Resting period to that observed during a speech delivered immediately after smoking a cigarette |
| Other | Plasma Epinephrine Concentration Response to Stress | After 4 weeks of paroxetine / placebo | Change in plasma epinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette |
| Other | Plasma Norepinephrine Concentration Response to Stress | After 4 weeks of paroxetine / placebo | Change in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Systolic Blood Pressure Response to Stress | After 4 weeks of paroxetine / placebo | mmHg | MEAN | |
| OTHER_PRE_SPECIFIED | Diastolic Blood Pressure Response to Stress | After 4 weeks of paroxetine / placebo | mm Hg | MEAN | |
| OTHER_PRE_SPECIFIED | Heart Rate Response to Stress | After 4 weeks of paroxetine / placebo | beats/minute | MEAN | |
| OTHER_PRE_SPECIFIED | Plasma Epinephrine Concentration Response to Stress | After 4 weeks of paroxetine / placebo | pg / ml | MEAN | |
| OTHER_PRE_SPECIFIED | Plasma Norepinephrine Concentration Response to Stress | After 4 weeks of paroxetine / placebo | pg / ml | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Systolic Blood Pressure Response to Stress | After 4 Weeks of Placebo | 16.85 | Standard Error 0.78 | mmHg | |
| Systolic Blood Pressure Response to Stress | After 4 Weeks of Paroxetine | 11.71 | Standard Error 0.78 | mmHg | |
| Diastolic Blood Pressure Response to Stress | After 4 Weeks of Placebo | 9.78 | Standard Error 0.49 | mm Hg | |
| Diastolic Blood Pressure Response to Stress | After 4 Weeks of Paroxetine | 8.07 | Standard Error 0.5 | mm Hg | |
| Heart Rate Response to Stress | After 4 Weeks of Placebo | 20.39 | Standard Error 0.56 | beats/minute | |
| Heart Rate Response to Stress | After 4 Weeks of Paroxetine | 20.02 | Standard Error 0.56 | beats/minute | |
| Plasma Epinephrine Concentration Response to Stress | After 4 Weeks of Placebo | 40.98 | Standard Error 3.42 | pg / ml | |
| Plasma Epinephrine Concentration Response to Stress | After 4 Weeks of Paroxetine | 34.94 | Standard Error 3.48 | pg / ml | |
| Plasma Norepinephrine Concentration Response to Stress | After 4 Weeks of Placebo | 72.31 | Standard Error 18.32 | pg / ml | |
| Plasma Norepinephrine Concentration Response to Stress | After 4 Weeks of Paroxetine | 63.37 | Standard Error 18.32 | pg / ml |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (4 Weeks) | STARTED | Placebo (4 Weeks) Then Paroxetine (4 Weeks) | 58 | |
| First Intervention (4 Weeks) | STARTED | Paroxetine (4 Weeks) the Placebo (4 Weeks) | 47 | |
| First Intervention (4 Weeks) | COMPLETED | Placebo (4 Weeks) Then Paroxetine (4 Weeks) | 40 | |
| First Intervention (4 Weeks) | COMPLETED | Paroxetine (4 Weeks) the Placebo (4 Weeks) | 35 | |
| First Intervention (4 Weeks) | NOT COMPLETED | Placebo (4 Weeks) Then Paroxetine (4 Weeks) | 18 | |
| First Intervention (4 Weeks) | NOT COMPLETED | Paroxetine (4 Weeks) the Placebo (4 Weeks) | 12 | |
| Second Intervention (4 Weeks) | STARTED | Placebo (4 Weeks) Then Paroxetine (4 Weeks) | 40 | |
| Second Intervention (4 Weeks) | STARTED | Paroxetine (4 Weeks) the Placebo (4 Weeks) | 35 | |
| Second Intervention (4 Weeks) | COMPLETED | Placebo (4 Weeks) Then Paroxetine (4 Weeks) | 33 | |
| Second Intervention (4 Weeks) | COMPLETED | Paroxetine (4 Weeks) the Placebo (4 Weeks) | 30 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | General disorders | During 4 Weeks of Placebo | 1 | 62 | |
| other | Dizziness | General disorders | During 4 Weeks of Paroxetine | 6 | 62 | |
| other | Gastrointenstinal symptoms | Gastrointestinal disorders | During 4 Weeks of Placebo | 7 | 62 | |
| other | Gastrointenstinal symptoms | Gastrointestinal disorders | During 4 Weeks of Paroxetine | 13 | 62 | |
| other | drowsiness | General disorders | During 4 Weeks of Placebo | 10 | 62 | |
| other | drowsiness | General disorders | During 4 Weeks of Paroxetine | 16 | 62 | |
| other | sexual side effects | Reproductive system and breast disorders | During 4 Weeks of Placebo | 1 | 62 | |
| other | sexual side effects | Reproductive system and breast disorders | During 4 Weeks of Paroxetine | 5 | 62 | |
| other | insomnia | General disorders | During 4 Weeks of Placebo | 3 | 62 | |
| other | insomnia | General disorders | During 4 Weeks of Paroxetine | 4 | 62 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | During 4 Weeks of Placebo | ||
| Total, all-cause mortality | During 4 Weeks of Paroxetine | ||
| Total, other adverse events | During 4 Weeks of Placebo | 34 | 62 |
| Total, other adverse events | During 4 Weeks of Paroxetine | 35 | 62 |
| Total, serious adverse events | During 4 Weeks of Placebo | 0 | 62 |
| Total, serious adverse events | During 4 Weeks of Paroxetine | 0 | 62 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23504241 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| K23DA017307 | Smoking, Antidepressants and Response to Mental Stress | KOTLYAR, MICHAEL | UNIVERSITY OF MINNESOTA | NATIONAL INSTITUTE ON DRUG ABUSE | 2005 to 2009 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| During 4 Weeks of Paroxetine vs During 4 Weeks of Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00218439
GET https://conductscience.org/api/trials/v1/NCT00218439/registered