Knowledge and Perception of Smoking Risks/Consequences
SmokCess
2 other identifiers
observational
200
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2007
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 27, 2008
CompletedFirst Posted
Study publicly available on registry
May 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedNovember 4, 2019
October 1, 2019
1.5 years
May 27, 2008
October 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The measure will be the differences in smoking perceptions/risk and motivation as assessed by the questionnaires between smokers with and without schizophrenia.
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).
Study Arms (2)
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.)
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National Institute on Drug Abuse (Johns Hopkins Bayview Campus)
Baltimore, Maryland, 21224, United States
Maryland Psychiatric Research Center, University of Maryland School of Medicine
Baltimore, Maryland, 21228, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deanna L Kelly, PharmD, BCPP
University of Maryland, College Park
- PRINCIPAL INVESTIGATOR
Steve Heishman, MD
National Institute on Drug Abuse (NIDA)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deanna L. Kelly, Pharm.D., BCPP, Cheif Treatment Research Program
Study Record Dates
First Submitted
May 27, 2008
First Posted
May 29, 2008
Study Start
December 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
November 4, 2019
Record last verified: 2019-10