Knowledge and Perception of Smoking Risks/Consequences

Schizophrenia Clinical Trial

— SmokCess  

Official title:

Knowledge and Perception of Smoking Risks/Consequences, Smoking Habits and Motivators for Smoking Cessation Among People With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686101
• Other study ID #: HP-00042643
• Secondary ID: NIDA #425
• Status: Completed
• Start date: December 2007
• Est. completion date: June 2009

Study information

• Verified date: October 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cigarette Smoking
• Schizophrenia

Locations

Country	Name	City	State
United States	Maryland Psychiatric Research Center, University of Maryland School of Medicine	Baltimore	Maryland
United States	National Institute on Drug Abuse (Johns Hopkins Bayview Campus)	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).