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Knowledge and Perception of Smoking Risks/Consequences (SmokCess)

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ClinicalTrials.gov Identifier: NCT00686101
Recruitment Status : Completed
First Posted : May 29, 2008
Last Update Posted : October 9, 2009
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
University of Maryland

Brief Summary:
This proposed 2-year questionnaire study examines views and attitudes regarding health risks of cigarette smoking, smoking patterns and motivators for cessation in smokers who suffer from schizophrenia compared to a sample of smokers without a major psychotic disorder.

Condition or disease
Cigarette Smoking Schizophrenia

Detailed Description:

This proposed 2-year questionnaire study examines views and attitudes regarding health risks of cigarette smoking, smoking patterns and motivators for cessation in smokers who suffer from schizophrenia compared to a sample of smokers without a major psychotic disorder. The specific goals of this study are to 1) examine differences in the perceived consequences of smoking, smoking habits, and motivation to quit between adults with and without schizophrenia and 2) identify clinical and demographic variables (e.g., age, race, sex, age of smoking onset, knowledge of smoking consequences, insurance status, family support, co-occurring substance abuse, education level, current health status) associated with motivation to quit smoking among individuals with and without schizophrenia. This secondary goal is exploratory in nature. We will identify potential predictors in each group separately and also assess if these potential predictors differ between groups.

The study will consist of one 2-hour visit, where each subject, after signing consent, will participate in a semi-structured interview as well as answer clinical and demographic information. Patient volunteers will be recruited from the MPRC Outpatient and Inpatient Programs and through NIDA. Control subjects will be recruited by MPRC and NIDA via newspaper advertisements from the Baltimore metropolitan area. We anticipate recruiting up to 110 schizophrenia patients for a total of 100 completers and up to 110 normal controls for a total of 100 completers. All participants will be 18-65 years old, will smoke cigarettes daily, and must not be interested in reducing or quitting tobacco use.


Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case Control
Official Title: Knowledge and Perception of Smoking Risks/Consequences, Smoking Habits and Motivators for Smoking Cessation Among People With Schizophrenia
Study Start Date : December 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
1
Normal control subjects (Males and females between 18-65 years, who smoke cigarettes daily, have an expired CO measurement of > 8 ppm to confirm cigarette smoking, who are not actively trying to quit smoking at the time of the interview, and who must be free from Axis I psychotic disorder.)
2
Subjects with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder (Males and females between 18-65 years, who smoke cigarettes daily, have an expired CO measurement of > 8 ppm to confirm cigarette smoking, and who are not actively trying to quit smoking at the time of the interview.)



Primary Outcome Measures :
  1. The measure will be the differences in smoking perceptions/risk and motivation as assessed by the questionnaires between smokers with and without schizophrenia. [ Time Frame: For each subject, the time frame primarily evaluated will be the length of his or her use of cigarettes, primarily (but the time frame may be extended to include other evaluated factors, such as education or family/economic support). ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patient volunteers will be recruited from the MPRC Outpatient and Inpatient Programs and through NIDA. Control subjects will be recruited by MPRC and NIDA via newspaper advertisements from the Baltimore metropolitan area. We anticipate recruiting up to 110 schizophrenia patients for a total of 100 completers and up to 110 normal controls for a total of 100 completers. All participants will be 18-65 years old, will smoke cigarettes daily, and must not be interested in reducing or quitting tobacco use. Nicotine dependence appears to be about equally represented among ethnic and racial backgrounds and gender.
Criteria

Inclusion Criteria:

  • Males and females between 18-65 years
  • Minimum of 5 cigarettes daily.
  • Expired CO measurement of > 8 ppm to confirm cigarette smoking
  • For the schizophrenia group, must have a DSM-IV diagnosis of schizophrenia or schizoaffective disorder.

Exclusion Criteria:

  • For the normal control group, must be free from Axis I psychotic disorder. (other psychiatric comorbidity will not be excluded)
  • For all subjects, anyone actively trying to quit smoking at the time of the interview.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686101


Locations
United States, Maryland
National Institute on Drug Abuse (Johns Hopkins Bayview Campus)
Baltimore, Maryland, United States, 21224
Maryland Psychiatric Research Center, University of Maryland School of Medicine
Baltimore, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Deanna L Kelly, PharmD, BCPP University of Maryland
Principal Investigator: Steve Heishman, MD National Institute on Drug Abuse (NIDA)

Responsible Party: Dr. Deanna L. Kelly, Pharm.D., BCPP, University of Maryland School of Medicine, Maryland Psychiatric Research Center
ClinicalTrials.gov Identifier: NCT00686101     History of Changes
Other Study ID Numbers: HP-00042643
NIDA #425
First Posted: May 29, 2008    Key Record Dates
Last Update Posted: October 9, 2009
Last Verified: October 2009

Keywords provided by University of Maryland:
Perception of risk
Smoking risks
Smoking consequences
Quitting smoking
Motivation to quit smoking
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders