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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00218439
First received: September 16, 2005
Last updated: April 28, 2014
Last verified: April 2014
  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
Drug: Placebo

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

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Systolic Blood Pressure Response to Stress [ Time Frame: After 4 weeks of paroxetine / placebo ] [ Designated as safety issue: No ]
    Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette


Other Outcome Measures:
  • Diastolic Blood Pressure Response to Stress [ Time Frame: After 4 weeks of paroxetine / placebo ] [ Designated as safety issue: No ]
    Change in diastolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette

  • Heart Rate Response to Stress [ Time Frame: After 4 weeks of paroxetine / placebo ] [ Designated as safety issue: No ]
    Change in heart rate from Resting period to that observed during a speech delivered immediately after smoking a cigarette

  • Plasma Epinephrine Concentration Response to Stress [ Time Frame: After 4 weeks of paroxetine / placebo ] [ Designated as safety issue: No ]
    Change in plasma epinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette

  • Plasma Norepinephrine Concentration Response to Stress [ Time Frame: After 4 weeks of paroxetine / placebo ] [ Designated as safety issue: No ]
    Change in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette


Enrollment: 105
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
Drug: Placebo
Experimental: 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
Drug: Placebo

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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Minnesota
College of Pharmacy
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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
Results First Received: October 29, 2013
Last Updated: April 28, 2014
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 July 26, 2014