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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
Results First Received: October 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Tobacco Use Disorder
Interventions: Drug: Paroxetine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo (4 Weeks) Then Paroxetine (4 Weeks) Placebo once daily in first intervention period and Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of second intervention period
Paroxetine (4 Weeks) the Placebo (4 Weeks) Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of first intervention period, placebo once daily in second intervention period

Participant Flow for 2 periods

Period 1:   First Intervention (4 Weeks)
    Placebo (4 Weeks) Then Paroxetine (4 Weeks)     Paroxetine (4 Weeks) the Placebo (4 Weeks)  
STARTED     58     47  
COMPLETED     40     35  
NOT COMPLETED     18     12  

Period 2:   Second Intervention (4 Weeks)
    Placebo (4 Weeks) Then Paroxetine (4 Weeks)     Paroxetine (4 Weeks) the Placebo (4 Weeks)  
STARTED     40     35  
COMPLETED     33     30  
NOT COMPLETED     7     5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes subjects who completed both laboratory sessions (n=62). One additional subject completed both laboratory sessions but did not have usable measures in the primary outcomes (cardiovascular measures) and was excluded

Reporting Groups
  Description
Placebo First 4 Weeks, Then Paroxetine for 4 Weeks Placebo once daily in first intervention period and Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of second intervention period
Paroxetine First 4 Weeks, Then Placebo for 4 Weeks Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of first intervention period, placebo once daily in second intervention period
Total Total of all reporting groups

Baseline Measures
    Placebo First 4 Weeks, Then Paroxetine for 4 Weeks     Paroxetine First 4 Weeks, Then Placebo for 4 Weeks     Total  
Number of Participants  
[units: participants]
  33     29     62  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     33     29     62  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  40.4  ± 14.1     40.0  ± 11.0     40.2  ± 12.7  
Gender  
[units: participants]
     
Female     16     14     30  
Male     17     15     32  
Region of Enrollment  
[units: participants]
     
United States     33     29     62  



  Outcome Measures
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1.  Primary:   Systolic Blood Pressure Response to Stress   [ Time Frame: After 4 weeks of paroxetine / placebo ]

2.  Other Pre-specified:   Diastolic Blood Pressure Response to Stress   [ Time Frame: After 4 weeks of paroxetine / placebo ]

3.  Other Pre-specified:   Heart Rate Response to Stress   [ Time Frame: After 4 weeks of paroxetine / placebo ]

4.  Other Pre-specified:   Plasma Epinephrine Concentration Response to Stress   [ Time Frame: After 4 weeks of paroxetine / placebo ]

5.  Other Pre-specified:   Plasma Norepinephrine Concentration Response to Stress   [ Time Frame: After 4 weeks of paroxetine / placebo ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Michael Kotlyar
Organization: University of Minnesota College of Pharmacy
phone: 612-625-1160
e-mail: kotly001@umn.edu


No publications provided by University of Minnesota - Clinical and Translational Science Institute

Publications automatically indexed to this study:

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