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CompletedNCT00686101SmokCessUpdated Nov 4, 2019

Knowledge and Perception of Smoking Risks/Consequences

An observational study in Cigarette Smoking and Schizophrenia, sponsored by University of Maryland, Baltimore. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-04.

Sponsored by University of Maryland, Baltimore · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
200
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cigarette Smoking
  • Schizophrenia

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Keywords

  • Perception of risk
  • Smoking risks
  • Smoking consequences
  • Quitting smoking
  • Motivation to quit smoking
  • Schizophrenia
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 200 is above the median of 178 across 491 observational studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
200 participants (actual)

Groups and cohorts

  • 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.)

06

What researchers measure

Primary outcomes

  1. The measure will be the differences in smoking perceptions/risk and motivation as assessed by the questionnaires between smokers with and without schizophrenia.

    Time frame: 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).

07

Study locations

2 sites
  • National Institute on Drug Abuse (Johns Hopkins Bayview Campus)
    Baltimore, Maryland 21224, United States
  • Maryland Psychiatric Research Center, University of Maryland School of Medicine
    Baltimore, Maryland 21228, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00686101
Lead sponsor
University of Maryland, Baltimore
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Deanna Kelly (Deanna L. Kelly, Pharm.D., BCPP, Cheif Treatment Research Program, University of Maryland, Baltimore) — Principal investigator
First posted
May 29, 2008
Start date
Dec 2007
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Nov 4, 2019

Study contacts

Deanna L Kelly, PharmD, BCPP
principal investigator · University of Maryland, College Park
Steve Heishman, MD
principal investigator · National Institute on Drug Abuse (NIDA)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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