Cigarette SmokingSmokCessNCT00686101
Knowledge and Perception of Smoking Risks/Consequences
An observational study of Cigarette Smoking and Schizophrenia, run by University of Maryland, Baltimore at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking, Schizophrenia
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2007to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institute on Drug Abuse (Johns Hopkins Bayview Campus)
Baltimore, Maryland, 21224
Maryland Psychiatric Research Center, University of Maryland School of Medicine
Baltimore, Maryland, 21228
About this study
Official title: Knowledge and Perception of Smoking Risks/Consequences, Smoking Habits and Motivators for Smoking Cessation Among People With Schizophrenia
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.
- Conditions
- Cigarette Smoking, Schizophrenia
- Keywords
- Perception of risk, Smoking risks, Smoking consequences, Quitting smoking, Motivation to quit smoking, Schizophrenia
- Medical subject headings
- Cigarette Smoking, Schizophrenia, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measure will be the differences in smoking perceptions/risk and motivation as assessed by the questionnaires between smokers with and without schizophrenia.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startDec 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Deanna Kelly, University of Maryland, Baltimore
- Investigators
- Deanna L Kelly, PharmD, BCPP, Principal investigator, University of Maryland, College ParkSteve Heishman, MD, Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686101
- Sponsor's protocol ID
- HP-00042643
- Other IDs
- NIDA #425
- Acronym
- SmokCess
- Status last verified
- Oct 2019
- First submitted
- 27 May 2008
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge and Perception of Smoking Risks/Consequences, Smoking Habits and Motivators for Smoking Cessation Among People With Schizophrenia
- ClinicalTrials.gov ID
- NCT00686101
- Acronym / sponsor ID
- SmokCess / HP-00042643
- Conditions
- Cigarette Smoking, Schizophrenia
- Keywords
- Perception of risk, Smoking risks, Smoking consequences, Quitting smoking, Motivation to quit smoking, Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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.) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deanna L Kelly, PharmD, BCPP principal investigator
University of Maryland, College Park
Steve Heishman, MD principal investigator
National Institute on Drug Abuse (NIDA)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cigarette Smoking and Schizophrenia, run by University of Maryland, Baltimore at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.