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

Smoking, Antidepressants, and Response to Mental Stress

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00218439

Enrollment

105

Registered

2005-09-22

Start date

2005-10-31

Completion date

2010-08-31

Last updated

2019-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use Disorder

Keywords

Smoking

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.

Interventions

DRUGParoxetine

10 mg for 1 week followed by 20 mg for 3 weeks

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Systolic Blood Pressure Response to Stress	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

Other

Measure	Time frame	Description
Diastolic Blood Pressure Response to Stress	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	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	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	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

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	33
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	29
Total	62

Baseline characteristics

Characteristic	Paroxetine First 4 Weeks, Then Placebo for 4 Weeks	Placebo First 4 Weeks, Then Paroxetine for 4 Weeks	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	29 Participants	33 Participants	62 Participants
Age, Continuous	40.0 years STANDARD_DEVIATION 11	40.4 years STANDARD_DEVIATION 14.1	40.2 years STANDARD_DEVIATION 12.7
Region of Enrollment United States	29 participants	33 participants	62 participants
Sex: Female, Male Female	14 Participants	16 Participants	30 Participants
Sex: Female, Male Male	15 Participants	17 Participants	32 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	34 / 62	35 / 62
serious Total, serious adverse events	0 / 62	0 / 62

Outcome results

Primary

Systolic Blood Pressure Response to Stress

Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette