- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Maryland
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Baltimore, Maryland, Forente stater, 21224
- National Institute on Drug Abuse (Johns Hopkins Bayview Campus)
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Baltimore, Maryland, Forente stater, 21228
- Maryland Psychiatric Research Center, University of Maryland School of Medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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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.
Tidsramme: 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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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Deanna L Kelly, PharmD, BCPP, University of Maryland, College Park
- Hovedetterforsker: Steve Heishman, MD, National Institute on Drug Abuse (NIDA)
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HP-00042643
- NIDA #425
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