Clinical trial NCT00218439: Effect of Paroxetine on Smokers' Cardiovascular Response to Stress - 1
Official title: Smoking, Antidepressants, and Response to Mental Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: Smoking
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-09-22
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Systolic Blood Pressure Response to Stress
timeFrame: After 4 weeks of paroxetine / placebo
Secondary outcomes:
Other outcomes:
measure: Diastolic Blood Pressure Response to Stress
timeFrame: After 4 weeks of paroxetine / placebo
measure: Heart Rate Response to Stress
timeFrame: After 4 weeks of paroxetine / placebo
measure: Plasma Epinephrine Concentration Response to Stress
timeFrame: After 4 weeks of paroxetine / placebo
measure: Plasma Norepinephrine Concentration Response to Stress
timeFrame: After 4 weeks of paroxetine / placebo
Locations:
city: Minneapolis
country: United States
facility: College of Pharmacy
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Michael Kotlyar
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.