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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00218439
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : May 23, 2014
Last Update Posted : November 1, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE September 16, 2005
First Posted Date  ICMJE September 22, 2005
Results First Submitted Date  ICMJE October 29, 2013
Results First Posted Date  ICMJE May 23, 2014
Last Update Posted Date November 1, 2019
Study Start Date  ICMJE October 2005
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2014)
Systolic Blood Pressure Response to Stress [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2005)
  • Physiological response to stress; measured at Weeks 4 and 8, immediately folllowing mental stress test
  • Psychological response to stress; measured at Weeks 4 and 8, immediately following mental stress test
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 28, 2014)
  • Diastolic Blood Pressure Response to Stress [ Time Frame: After 4 weeks of paroxetine / placebo ]
    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 ]
    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 ]
    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 ]
    Change in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Paroxetine on Smokers' Cardiovascular Response to Stress - 1
Official Title  ICMJE Smoking, Antidepressants, and Response to Mental Stress
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tobacco Use Disorder
Intervention  ICMJE
  • Drug: Paroxetine
    10 mg for 1 week followed by 20 mg for 3 weeks
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: 1
    Active medication for 4 weeks followed by placebo for 4 weeks
    Interventions:
    • Drug: Paroxetine
    • Drug: Placebo
  • Experimental: 2
    Placebo for 4 weeks followed by active for 4 weeks
    Interventions:
    • Drug: Paroxetine
    • Drug: Placebo
Publications * Kotlyar M, al'Absi M, Thuras P, Vuchetich JP, Adson DE, Nowack AL, Hatsukami DK. Effect of paroxetine on physiological response to stress and smoking. Psychosom Med. 2013 Apr;75(3):236-43. doi: 10.1097/PSY.0b013e3182898f6d. Epub 2013 Mar 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2014)
105
Original Enrollment  ICMJE
 (submitted: September 16, 2005)
60
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00218439
Other Study ID Numbers  ICMJE 0310M52790
K23DA017307-01 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Michael Kotlyar University of Minnesota
PRS Account University of Minnesota
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP