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Physiological Responses in Tobacco Chippers

This study is currently recruiting participants.
Verified January 2013 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
Barry S. Oken, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01237834
First received: November 9, 2010
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

This study will analyze a series of biological and behavioral markers in different populations of smokers. The study groups will differ in their cigarette consumption and level of nicotine dependence. This analysis will help to identify factors that might be important for smoking behavior and nicotine addiction. The results from this study will contribute to improve campaigns for smoking prevention and treatments for smoking cessation.


Condition
Smoking
Stress

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Physiological Responses in Tobacco Chippers (Non Nicotine-dependent Light Smokers)

Resource links provided by NLM:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Electroencephalography [ Time Frame: Changes from baseline during a hard cognitive task ] [ Designated as safety issue: No ]
    Electroencephalography will be measured during performance on a hard cognitive task.


Secondary Outcome Measures:
  • Salivary cortisol [ Time Frame: Changes from baseline during performance on a hard cognitive task ] [ Designated as safety issue: No ]
    Salivary cortisol will be measured at baseline, during a hard cognitive task and 30 minutes after the cognitive task.


Estimated Enrollment: 85
Study Start Date: November 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Heavy smokers, 15 or more cigarettes/day
Nicotine dependent.
Light smokers (chippers)
Less than 2 cigarettes/day, at least 2 days/week. Non nicotine-dependent.
Non smokers

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

General population

Criteria

Inclusion Criteria:

  • healthy adults
  • age 25-55

Exclusion Criteria:

  • alcohol or drug addiction
  • unstable significant medical problems
  • neurologic disease
  • medications known to affect CNS function or impact physiologic parameters measured in the study
  • significant visual impairment
  • breath carbon monoxide (BCO) level of less than 10 ppm for smokers
  • breath carbon monoxide (BCO) level of more than 5 ppm for non-smokers
  • for heavy regular smokers: erratic smoking history (i.e. they must have smoked an average of 15 cigarettes daily for at least one year)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01237834

Contacts
Contact: Laura Carim Todd, PhD 503-494-7219 carimtod@ohsu.edu

Locations
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Laura Carim Todd, PhD     503-494-7219     carimtod@ohsu.edu    
Principal Investigator: Laura Carim Todd, PhD            
Principal Investigator: Barry Oken, MD            
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Barry Oken Oregon Health and Science University
Principal Investigator: Laura Carim Todd Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Barry S. Oken, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01237834     History of Changes
Other Study ID Numbers: IRB6698
Study First Received: November 9, 2010
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 23, 2013