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

Further Study Details: 

Primary Outcomes: Physiological response to stress; measured at Weeks 4 and 8; Psychological response to stress; measured at Weeks 4 and 8
Expected Total Enrollment:  60

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. Participants will be randomly assigned to receive one treatment followed by the other treatment. 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 treatment, 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 treatments, participants will again undergo the procedure for mental stress testing and evaluation.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Smokes an average of at least 15 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00218439

Minnesota
      College of Pharmacy, Minneapolis,  Minnesota,  55455,  United States

Study chairs or principal investigators

Michael Kotlyar,  Principal Investigator,  University of Minnesota Twin Cities   

Study ID Numbers:  NIDA-17307-1; K23-17307-1
Last Updated:  September 22, 2005
Record first received:  September 16, 2005
ClinicalTrials.gov Identifier:  NCT00218439
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-27