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

Official Title: “Smoking, Antidepressants, and Response to Mental Stress”

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.

Smokers report that they often smoke cigarettes during stressful times. Smoking and stress produce similar physiological responses such as increases in heart rate, blood pressure, and adrenaline levels. The combination of smoking and stress results in greater increases in these physiological responses compared to smoking or stress alone. Such increases are thought to be harmful to cardiovascular health. Additionally, smokers with exaggerated responses to stress may be more likely to relapse following a smoking cessation attempt.

The purpose of this study is to assess the effects of paroxetine, a selective serotonin reuptake inhibitor (SSRI), on the cardiovascular response to stress after smoking.

Participants in this double-blind, placebo-controlled study will receive 1 month of paroxetine and 1 month of placebo with the order of which is taken during the first month randomly assigned. Paroxetine will be administered at a daily dose of 10 mg for the first week and increased to a daily dose of 20 mg for the remainder of the study. After one month of medication, participants will abstain from smoking for one night and then undergo mental stress testing the following day. Immediately prior to the mental stress testing, participants will smoke a cigarette. Mental stressors will include speaking and math tasks.

Physiological measures of stress (e.g., blood pressure, heart rate, and plasma catecholamine concentrations) and subjective measures of stress will be evaluated.

Following the second month of medication, participants will again undergo the procedure for mental stress testing and evaluation.

Intervention(s) in this Clinical Trial

• Drug: Paroxetine
  • 10 mg for 1 week followed by 20 mg for 3 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Active medication for 4 weeks followed by placebo for 4 weeks
• Placebo Comparator: 2
  • Placebo for 4 weeks followed by active for 4 weeks

Primary Measures

• Physiological response to stress
  • Time Frame: weeks 4 and 8
    Safety Issue?: No
• Psychological response to stress
  • Time Frame: measured at week 4 and week 8
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: University of Minnesota - Clinical and Translational Science Institute Other

Overall Clinical Trial Officials and Contacts

Michael Kotlyar Principal Investigator University of Minnesota - Clinical and Translational Science Institute  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00218439

Study ID Number: NIDA-17307-1

ClinicalTrials.gov Identifier: NCT00218439

Health Authority: United States: Federal Government