Tobacco DependenceNCT00501007
Predictors of Treatment Outcome for Smokers With and Without Schizophrenia
An observational study of Tobacco Dependence, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The primary purpose of this investigation is to determine the predictive value of task persistence as measured by a mirror tracing task. A secondary purpose is to evaluate differences in task persistence in smokers with or without schizophrenia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Jan 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals from mental health centers in Central New Jersey or non-psychiatric controls from the community
Who may be able to join
- Current smokers must be over the age of 18,
- Must fit into the diagnostic groups schizophrenia / schizoaffective disorder; or the non-schizophrenia group.
- Must smoke at least 10 cigarettes per day
- Must be capable of giving informed consent as measured by Folstein Mini Mental Status Exam of at least 22.
Who cannot join
- Those unable to give informed consent.
- Psychotic disorders other than schizophrenia
Trial locations and contacts
1 site in 1 country.
United States1 site
UMDNJ Tobacco Dependence Clinic
New Brunswick, New Jersey, 08901
About this study
The primary purpose of this investigation is to determine the predictive value of task persistence as measured by a mirror tracing task. A secondary purpose is to evaluate differences in task persistence in smokers with or without schizophrenia. It is hypothesized that task persistence in smokers in both diagnostic categories (schizophrenia and no schizophrenia) will predict tobacco dependence treatment outcome at one and six months. It is also hypothesized that smokers with schizophrenia will show lower levels of task persistence after controlling for other motor skills than smokers without schizophrenia.
Read the detailed description
Please see brief summary above.
- Conditions
- Tobacco Dependence
- Medical subject headings
- Tobacco Use Disorder
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 |
|---|---|---|
| Non-psychiatric smokers | Smokers not meeting criteria for Schizophrenia or Schizoaffective Disorder | |
| Smokers with Schizophrenia | Smokers meeting criteria for schizophrenia or schizoaffective disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mirror-tracing Persistence (in Seconds)
Number of seconds participants continued working on a mirror tracing task before giving up.
Measured: baseline
Secondary outcomes (1)
Persistence as a Prospective Predictor of Smoking Cessation
Analysis of Generalized Estimating Equations (GEE) parameter estimates based on empirical standard error estimates, using an exchangeable working correlation structure, with smoking abstinence as outcome variable, and task persistence, time, diagnosis, ability, Fagerstrom Test for Nicotine Dependence (FTND) score, and the interaction between disorder and persistence as explanatory variables.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startFeb 2005
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Marc L. Steinberg, PH.D, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501007
- Sponsor's protocol ID
- K23DA018203
- Other IDs
- K23DA018203
- Status last verified
- Jul 2017
- First submitted
- 11 Jul 2007
- Last updated
- 17 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Treatment Outcome for Smokers With and Without Schizophrenia
- ClinicalTrials.gov ID
- NCT00501007
- Acronym / sponsor ID
- K23DA018203
- Conditions
- Tobacco Dependence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2005
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 13 Jul 2007 (estimated)
- Results
- Posted 13 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this investigation is to determine the predictive value of task persistence as measured by a mirror tracing task. A secondary purpose is to evaluate differences in task persistence in smokers with or without schizophrenia. It is hypothesized that task persistence in smokers in both diagnostic categories (schizophrenia and no schizophrenia) will predict tobacco dependence treatment outcome at one and six months. It is also hypothesized that smokers with schizophrenia will show lower levels of task persistence after controlling for other motor skills than smokers without schizophrenia.
Detailed description
Please see brief summary above.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-psychiatric smokers | – | –Smokers not meeting criteria for Schizophrenia or Schizoaffective Disorder |
| Smokers with Schizophrenia | – | –Smokers meeting criteria for schizophrenia or schizoaffective disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals from mental health centers in Central New Jersey or non-psychiatric controls from the community
Key inclusion criteria (4 listed)
- Current smokers must be over the age of 18,
- Must fit into the diagnostic groups schizophrenia / schizoaffective disorder; or the non-schizophrenia group.
- Must smoke at least 10 cigarettes per day
- Must be capable of giving informed consent as measured by Folstein Mini Mental Status Exam of at least 22.
Key exclusion criteria (2 listed)
- Those unable to give informed consent.
- Psychotic disorders other than schizophrenia
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
Mirror-tracing Persistence (in Seconds)
Time frame: baseline
Number of seconds participants continued working on a mirror tracing task before giving up.
1 secondary outcome
Persistence as a Prospective Predictor of Smoking Cessation
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Marc L. Steinberg, PH.D principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tobacco Dependence, run by Rutgers, The State University of New Jersey at 1 site 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 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 13 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mirror-tracing Persistence (in Seconds) (time frame: baseline). 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 17 Jul 2017.