Effect of Paroxetine on Smokers' Cardiovascular Response to Stress

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Active medication for 4 weeks followed by placebo for 4 weeks

Group Type EXPERIMENTAL

Paroxetine

Intervention Type DRUG

10 mg for 1 week followed by 20 mg for 3 weeks

Placebo

Intervention Type DRUG

2

Placebo for 4 weeks followed by active for 4 weeks

Group Type EXPERIMENTAL

Paroxetine

Intervention Type DRUG

10 mg for 1 week followed by 20 mg for 3 weeks

Placebo

Intervention Type DRUG

Interventions

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Paroxetine

10 mg for 1 week followed by 20 mg for 3 weeks

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes