- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00686101
Knowledge and Perception of Smoking Risks/Consequences (SmokCess)
Knowledge and Perception of Smoking Risks/Consequences, Smoking Habits and Motivators for Smoking Cessation Among People With Schizophrenia
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Maryland
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Baltimore, Maryland, Förenta staterna, 21224
- National Institute on Drug Abuse (Johns Hopkins Bayview Campus)
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Baltimore, Maryland, Förenta staterna, 21228
- Maryland Psychiatric Research Center, University of Maryland School of Medicine
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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.)
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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.)
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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The measure will be the differences in smoking perceptions/risk and motivation as assessed by the questionnaires between smokers with and without schizophrenia.
Tidsram: 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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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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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Deanna L Kelly, PharmD, BCPP, University of Maryland, College Park
- Huvudutredare: Steve Heishman, MD, National Institute on Drug Abuse (NIDA)
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HP-00042643
- NIDA #425
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