Clinical trial NCT00686101: Knowledge and Perception of Smoking Risks/Consequences
Official title: Knowledge and Perception of Smoking Risks/Consequences, Smoking Habits and Motivators for Smoking Cessation Among People With Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cigarette Smoking
Schizophrenia
Keywords: Perception of risk
Smoking risks
Smoking consequences
Quitting smoking
Motivation to quit smoking
Schizophrenia
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-05-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: The measure will be the differences in smoking perceptions/risk and motivation as assessed by the questionnaires between smokers with and without schizophrenia.
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: National Institute on Drug Abuse (Johns Hopkins Bayview Campus)
state: Maryland
city: Baltimore
country: United States
facility: Maryland Psychiatric Research Center, University of Maryland School of Medicine
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Deanna L Kelly, PharmD, BCPP
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute on Drug Abuse (NIDA)
name: Steve Heishman, MD
role: PRINCIPAL_INVESTIGATOR
References: