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Effect of Paroxetine on Smokers' Cardiovascular Response to Stress - 1
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), April 2009
First Received: September 16, 2005   Last Updated: April 6, 2009   History of Changes
Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
University of Minnesota
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00218439
  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: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacodynamics Study
Official Title: Smoking, Antidepressants, and Response to Mental Stress

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 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 ]

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
1: Experimental
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
2: Placebo Comparator
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
Criteria

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
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218439

Locations
United States, Minnesota
College of Pharmacy Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Michael Kotlyar     612-625-1160     kotly001@umn.edu    
Sponsors and Collaborators
University of Minnesota
Investigators
Principal Investigator: Michael Kotlyar University of Minnesota
  More Information

No publications provided

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 01, 2009