NCT00686101

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

1.5 years

First QC Date

May 27, 2008

Last Update Submit

October 31, 2019

Conditions

Keywords

Perception of riskSmoking risksSmoking consequencesQuitting smokingMotivation to quit smokingSchizophrenia

Outcome Measures

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.

    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).

Study Arms (2)

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.)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Institute on Drug Abuse (Johns Hopkins Bayview Campus)

Baltimore, Maryland, 21224, United States

Location

Maryland Psychiatric Research Center, University of Maryland School of Medicine

Baltimore, Maryland, 21228, United States

Location

MeSH Terms

Conditions

Cigarette SmokingSchizophreniaSmoking Cessation

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco UseSchizophrenia Spectrum and Other Psychotic DisordersMental DisordersHealth Behavior

Study Officials

  • Deanna L Kelly, PharmD, BCPP

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR
  • Steve Heishman, MD

    National Institute on Drug Abuse (NIDA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deanna L. Kelly, Pharm.D., BCPP, Cheif Treatment Research Program

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 29, 2008

Study Start

December 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

November 4, 2019

Record last verified: 2019-10

Locations