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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) University of Minnesota |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00218439 |
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.
Condition | Intervention |
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Tobacco Use Disorder |
Drug: Paroxetine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacodynamics Study |
Official Title: | Smoking, Antidepressants, and Response to Mental Stress |
Estimated Enrollment: | 60 |
Study Start Date: | October 2005 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Active medication for 4 weeks followed by placebo for 4 weeks
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Drug: Paroxetine
10 mg for 1 week followed by 20 mg for 3 weeks
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2: Placebo Comparator
Placebo for 4 weeks followed by active for 4 weeks
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Drug: Paroxetine
10 mg for 1 week followed by 20 mg for 3 weeks
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |
College of Pharmacy | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Michael Kotlyar 612-625-1160 kotly001@umn.edu |
Principal Investigator: | Michael Kotlyar | University of Minnesota |
Responsible Party: | University of Minnesota ( Michael Kotlyar ) |
Study ID Numbers: | NIDA-17307-1, K23-17307-1, DPMC |
Study First Received: | September 16, 2005 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00218439 History of Changes |
Health Authority: | United States: Federal Government |
Neurotransmitter Agents Tobacco Use Disorder Psychotropic Drugs Stress Disorders of Environmental Origin Paroxetine Serotonin Uptake Inhibitors |
Serotonin Smoking Mental Disorders Stress, Psychological Substance-Related Disorders Antidepressive Agents, Second-Generation Antidepressive Agents |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Tobacco Use Disorder Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Paroxetine Serotonin Uptake Inhibitors |
Pharmacologic Actions Serotonin Agents Mental Disorders Therapeutic Uses Substance-Related Disorders Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |