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

Tobacco Use Disorder Clinical Trial

Official title:

Smoking, Antidepressants, and Response to Mental Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218439
• Other study ID #: 0310M52790
• Secondary ID: K23DA017307-01DP
• Status: Completed
• Phase: N/A
• Start date: October 2005
• Est. completion date: August 2010

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

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

Locations

Country	Name	City	State
United States	College of Pharmacy	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diastolic Blood Pressure Response to Stress	Change in diastolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette	After 4 weeks of paroxetine / placebo
Other	Heart Rate Response to Stress	Change in heart rate from Resting period to that observed during a speech delivered immediately after smoking a cigarette	After 4 weeks of paroxetine / placebo
Other	Plasma Epinephrine Concentration Response to Stress	Change in plasma epinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette	After 4 weeks of paroxetine / placebo
Other	Plasma Norepinephrine Concentration Response to Stress	Change in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette	After 4 weeks of paroxetine / placebo
Primary	Systolic Blood Pressure Response to Stress	Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette	After 4 weeks of paroxetine / placebo