Effect of Paroxetine on Smokers' Cardiovascular Response to Stress - 1
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Purpose
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 |
|---|---|
|
Tobacco Use Disorder |
Drug: Paroxetine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Smoking, Antidepressants, and Response to Mental Stress |
- Physiological response to stress [ Time Frame: weeks 4 and 8 ] [ Designated as safety issue: No ]
- Psychological response to stress [ Time Frame: measured at week 4 and week 8 ] [ Designated as safety issue: No ]
| Enrollment: | 75 |
| Study Start Date: | October 2005 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Active medication for 4 weeks followed by placebo for 4 weeks
|
Drug: Paroxetine
10 mg for 1 week followed by 20 mg for 3 weeks
|
|
Placebo Comparator: 2
Placebo for 4 weeks followed by active for 4 weeks
|
Drug: Paroxetine
10 mg for 1 week followed by 20 mg for 3 weeks
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Minnesota | |
| College of Pharmacy | |
| Minneapolis, Minnesota, United States, 55455 | |
| Principal Investigator: | Michael Kotlyar | University of Minnesota - Clinical and Translational Science Institute |
More Information
No publications provided by University of Minnesota - Clinical and Translational Science Institute
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT00218439 History of Changes |
| Other Study ID Numbers: | NIDA-17307-1, K23DA017307-01, DPMC |
| Study First Received: | September 16, 2005 |
| Last Updated: | April 25, 2012 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Substance-Related Disorders Mental Disorders Paroxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013