SmokCess: Knowledge and Perception of Smoking Risks/Consequences

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Completed

CT.gov ID

NCT00686101

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

200

Enrollment

Locations

Duration (Months)

100

Patients Per Site

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Cigarette Smoking Schizophrenia

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.

Study Design

Study Type:

Observational

Actual Enrollment :

200 participants

Observational Model:

Case-Control

Time Perspective:

Other

Official Title:

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

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.)
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.)

Outcome Measures

Primary Outcome Measures

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).]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute on Drug Abuse (Johns Hopkins Bayview Campus)	Baltimore	Maryland	United States	21224
2	Maryland Psychiatric Research Center, University of Maryland School of Medicine	Baltimore	Maryland	United States	21228

Sponsors and Collaborators

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

Investigators

Principal Investigator: Deanna L Kelly, PharmD, BCPP, University of Maryland, College Park
Principal Investigator: Steve Heishman, MD, National Institute on Drug Abuse (NIDA)