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

Not Applicable

Completed

Conditions: Tobacco Use Disorder

Interventions: Drug: Paroxetine
Drug: Placebo

Registration Number: NCT00218439

Lead Sponsor: University of Minnesota

Brief 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.

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 105

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Paroxetine	Active medication for 4 weeks followed by placebo for 4 weeks
1	Placebo	Active medication for 4 weeks followed by placebo for 4 weeks
2	Paroxetine	Placebo for 4 weeks followed by active for 4 weeks
2	Placebo	Placebo for 4 weeks followed by active for 4 weeks

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures