Knowledge and Perception of Smoking Risks/Consequences

NCT ID: NCT00686101

Last Updated: 2019-11-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-06-30

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.

Conditions

Cigarette Smoking; Schizophrenia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

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.)

No interventions assigned to this group

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.)

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Deanna Kelly

Deanna L. Kelly, Pharm.D., BCPP, Cheif Treatment Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deanna L Kelly, PharmD, BCPP

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Steve Heishman, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute on Drug Abuse (NIDA)

Locations

National Institute on Drug Abuse (Johns Hopkins Bayview Campus)

Baltimore, Maryland, United States

Maryland Psychiatric Research Center, University of Maryland School of Medicine

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NIDA #425

Identifier Type: -

Identifier Source: secondary_id

HP-00042643

Identifier Type: -

Identifier Source: org_study_id