NCT00218439

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

May 23, 2014

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

4.8 years

First QC Date

September 16, 2005

Results QC Date

October 29, 2013

Last Update Submit

October 30, 2019

Conditions

Tobacco Use Disorder

Keywords

Smoking

Outcome Measures

Primary Outcomes (1)

  • 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

    After 4 weeks of paroxetine / placebo

Other Outcomes (4)

  • Diastolic Blood Pressure Response to Stress

    After 4 weeks of paroxetine / placebo

  • Heart Rate Response to Stress

    After 4 weeks of paroxetine / placebo

  • Plasma Epinephrine Concentration Response to Stress

    After 4 weeks of paroxetine / placebo

  • +1 more other outcomes

Study Arms (2)

1

EXPERIMENTAL

Active medication for 4 weeks followed by placebo for 4 weeks

Drug: ParoxetineDrug: Placebo

2

EXPERIMENTAL

Placebo for 4 weeks followed by active for 4 weeks

Drug: ParoxetineDrug: Placebo

Interventions

ParoxetineDRUG

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

12
PlaceboDRUG
12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smokes an average of at least 10 cigarettes per day during the year prior to enrollment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Pharmacy

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • 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.

    PMID: 23504241DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderSmoking

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Michael Kotlyar
Organization
University of Minnesota College of Pharmacy
kotly001@umn.edu
612-625-1160

Study Officials

  • Michael Kotlyar

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

October 1, 2005

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

November 1, 2019

Results First Posted

May 23, 2014

Record last verified: 2019-10

Locations

US(1)