N/A N=105 Randomized Double-blind Treatment

Effect of Paroxetine on Smokers' Cardiovascular Response to Stress - 1

Tobacco Use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00218439 ↗

Enrolled (actual)

105

Serious AEs

0.0%

Results posted

May 2014

Primary outcome: Primary: Systolic Blood Pressure Response to Stress — 16.85; 11.71 mmHg — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Paroxetine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Aug 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Systolic Blood Pressure Response to Stress	16.85; 11.71	<0.001 sig

Summary

Smokers report that they often smoke cigarettes during stressful times. The combined effect of smoking and exposure to stress leads to exaggerated increases in blood pressure, heart rate and other measures of stress response. This combination may result in greater cardiovascular harm than either smoking or stress alone. The purpose of this study is to determine the effects of paroxetine on the response to stress after smoking.

Eligibility Criteria

Inclusion Criteria

Smokes an average of at least 10 cigarettes per day during the year prior to enrollment

Exclusion Criteria

Interested in quitting smoking within the 3 months following enrollment
Current unstable medical condition
Substance abuse within the year prior to enrollment
Current use of any medications (e.g., psychoactive medications, antihypertensives) that, in the opinion of the investigators, might interfere with study measures or that would be expected to interact with paroxetine (e.g., CYP2D6 substrates)
Smoking cessation therapy within the 3 months prior to enrollment
Regular use of any form of tobacco other than cigarettes
Significant psychiatric disorders as assessed by the PRIME-MD and verified by a clinician
History of hypersensitivity to any selective serotonin reuptake inhibitor
Pregnancy or breastfeeding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00218439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.