SchizophreniaNCT00382915
Measuring Smoking Behavior in People With Schizophrenia and Bipolar Disorder
An observational study of Schizophrenia and Bipolar Disorder, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
This study will evaluate the differences in smoking behavior, nicotine intake, and nicotine boost among people with schizophrenia, bipolar disorder, or no mental illness. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- What is being tested?
- CReSSmicro handheld topography device
- Type of treatment
- Medical device
- How many people
- 276 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Dec 2010
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be 100 smokers with schizophrenia, 100 smokers with bipolar disorder and 100 smokers without mental illness. This will include smokers within the New Jersey metropolitan area, who receive treatment at the UMDNJ-University Behavioral Health Care System (UBHC) or at another outpatient behavioral health care agency. A community sample of healthy volunteer smokers without mental illness will be recruited through advertisements to participate in the study.
Who may be able to join
- For smokers with schizophrenia or bipolar disorder:
- Meets DSM-IV diagnostic criteria for schizophrenia or bipolar I disorder
- Smokes 10 or more cigarettes every day
- Has been stable on current psychiatric medications for at least 1 month prior to study entry
- For control smokers without mental illness:
- Smokes 10 or more cigarettes every day
Who cannot join
- For smokers with schizophrenia or bipolar disorder:
- Current or past suicidal ideation, behavior, or suicide attempt within 30 days prior to study entry
- Psychiatric hospitalization within 30 days prior to study entry
- Inability to read English or inability to sufficiently understand study documents written in English
- Pregnant, breastfeeding, or plans to become pregnant within 1 month of study entry
- Current use of any non-cigarette forms of tobacco (e.g., cigars, pipes, smokeless tobacco, or ultralight cigarettes)
Show all 20Show fewer
- Current substance abuse problem, as defined by DAST or AUDIT criteria
- Significant cognitive impairment that may interfere with study participation, as defined by a Folstein Mini-Mental Status exam score of less than 22
- For control smokers without mental illness:
- Any DSM-defined mental disorder within 1 year prior to study entry
- Inability to read English or inability to sufficiently understand study documents written in English
- Concomitant use of nicotine replacement therapy (e.g., gum, patch, inhaler, nasal spray, or lozenge), clonidine, bupropion, or nortriptyline
- Pregnant, breastfeeding, or plans to become pregnant within 1 month of study entry
- Current use of any non-cigarette forms of tobacco (e.g., cigars, pipes, smokeless tobacco, or ultralight cigarettes)
- Diagnosis or treatment for an episode of any mental disorder (e.g., depression or anxiety) within 1 year prior to study entry
- Lifetime diagnosis of bipolar disorder or schizophrenia
- Lifetime history of any psychotic symptoms
- Lifetime use of antipsychotic medication for any reason
- Use of any antidepressants, mood stabilizers, or anti-anxiety medications for any reason within 6 months prior to study entry
- Current substance abuse problem, as defined by DAST or AUDIT criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
UMDNJ-Robert Wood Johnson Medical School, Department of Psychiatry, Division of Addictions
New Brunswick, New Jersey, 08901
About this study
Official title: Nicotine Intake in Smokers With Schizophrenia
This study will evaluate the differences in smoking behavior, nicotine intake, and nicotine boost among people with schizophrenia, bipolar disorder, or no mental illness.
Read the detailed description
People with schizophrenia, a disabling mental disorder, smoke at rates three times higher than those of the general population. They also tend to develop serious medical problems due to this heavy smoking. Little is known, however, about the relationship between schizophrenia and smoking. Smoking topography, the study of cigarette-puffing behavior, may help to uncover important information about the smoking habits of people with schizophrenia, and how they differ from smokers who do not have a mental illness. To develop more effective treatment approaches for schizophrenic smokers, a better understanding of nicotine addiction in this population is needed. This study will use hand-held smoking topography devices and blood tests to measure smoking behavior and nicotine levels in people with schizophrenia. This information will be compared to similar measurements in people with no mental illness and in people with bipolar disorder, another disorder associated with high rates of heavy smoking.
Participation in this open-label, observational study will last approximately 1 to 2 weeks, and will consist of two to three study visits. The first visit will last about 2 hours, and will include screening procedures, completion of baseline questionnaires, and a practice session of smoking topography. Subjects will return on a second day (Day 2) for the remainder of the study procedures to assess their smoking puffing behavior and nicotine intake from usual cigarette smoking, which will occur within 1 week of the Day 1 assessments. On the afternoon prior to Day 2 subjects will have a brief appointment to review instructions for using the topography device. They will take the topography with them and be instructed to use it as they smoke ad-lib that evening at home. This will serve as a second practice session for getting used to the topography device. They will also be instructed to use the device for all cigarettes smoked upon awakening the next day at 6am (Day 2), including the first cigarette of the day. They will go to the study site for the first of three blood tests at 9:30 A.M, after which they will be allowed to leave the study site to continue with their daily activities. They will use the smoking topography device throughout the day, until 3 P.M. At this time, study staff will go to each participant's location to collect the device. Participants will have two additional blood tests over the course of the study to measure nicotine levels.
- Conditions
- Schizophrenia, Bipolar Disorder
- Being tested
- CReSSmicro handheld topography device
- Keywords
- Smoking, Topography, Nicotine
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CReSSmicro handheld topography deviceDevice
The CReSS micro device represents the state-of-the-art technology for measurements of ambulatory puff topography taken in the smoker's natural environment. Although all topography measurements are limited, at least to some degree, by the artificial act of smoking while using a device, or smoking through a mouthpiece, this small, lightweight and portable device is easy to use outside of the laboratory setting to capture more naturalistic smoking behavior and allows for less intrusion from the research team and research environment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Smokers with schizophrenia Receives: Device: CReSSmicro handheld topography device | |
| 2 | Smokers with bipolar disorder Receives: Device: CReSSmicro handheld topography device | |
| 3 | Smokers without any mental illness Receives: Device: CReSSmicro handheld topography device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking behavior and nicotine levels in those diagnosed with schizophrenia, those diagnosed with bipolar disorder and, those without a current mental illness
Measured: Measured at Hour 24
Secondary outcomes (1)
Difference in blood levels of cotinine in smokers with schizophrenia compared to controls
Measured: Measured at Hour 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Prospective
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jill M. Williams, MD, Principal investigator, Rutgers, The State University of New JerseyKunal K. Gandhi, MBBS, MPH, Study director, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382915
- Sponsor's protocol ID
- R01MH076672
- Other IDs
- R01MH076672, DAHBR 96-BHB
- Status last verified
- May 2013
- First submitted
- 29 Sep 2006
- Last updated
- 27 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Williams JM, Gandhi KK, Lu SE, Kumar S, Steinberg ML, Cottler B, Benowitz NL. Shorter interpuff interval is associated with higher nicotine intake in smokers with schizophrenia. Drug Alcohol Depend. 2011 Nov 1;118(2-3):313-9. doi: 10.1016/j.drugalcdep.2011.04.009. Epub 2011 May 18.
PubMed 21596491Williams JM, Gandhi KK, Benowitz NL. Carbamazepine but not valproate induces CYP2A6 activity in smokers with mental illness. Cancer Epidemiol Biomarkers Prev. 2010 Oct;19(10):2582-9. doi: 10.1158/1055-9965.EPI-10-0384. Epub 2010 Aug 18.
PubMed 20719908Williams JM, Gandhi KK, Lu SE, Kumar S, Shen J, Foulds J, Kipen H, Benowitz NL. Higher nicotine levels in schizophrenia compared with controls after smoking a single cigarette. Nicotine Tob Res. 2010 Aug;12(8):855-9. doi: 10.1093/ntr/ntq102. Epub 2010 Jun 28.
PubMed 20584771
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Intake in Smokers With Schizophrenia
- ClinicalTrials.gov ID
- NCT00382915
- Acronym / sponsor ID
- R01MH076672
- Conditions
- Schizophrenia, Bipolar Disorder
- Keywords
- Smoking, Topography, Nicotine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Oct 2006 (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 study will evaluate the differences in smoking behavior, nicotine intake, and nicotine boost among people with schizophrenia, bipolar disorder, or no mental illness.
Detailed description
People with schizophrenia, a disabling mental disorder, smoke at rates three times higher than those of the general population. They also tend to develop serious medical problems due to this heavy smoking. Little is known, however, about the relationship between schizophrenia and smoking. Smoking topography, the study of cigarette-puffing behavior, may help to uncover important information about the smoking habits of people with schizophrenia, and how they differ from smokers who do not have a mental illness. To develop more effective treatment approaches for schizophrenic smokers, a better understanding of nicotine addiction in this population is needed. This study will use hand-held smoking topography devices and blood tests to measure smoking behavior and nicotine levels in people with schizophrenia. This information will be compared to similar measurements in people with no mental illness and in people with bipolar disorder, another disorder associated with high rates of heavy smoking.
Participation in this open-label, observational study will last approximately 1 to 2 weeks, and will consist of two to three study visits. The first visit will last about 2 hours, and will include screening procedures, completion of baseline questionnaires, and a practice session of smoking topography. Subjects will return on a second day (Day 2) for the remainder of the study procedures to assess their smoking puffing behavior and nicotine intake from usual cigarette smoking, which will occur within 1 week of the Day 1 assessments. On the afternoon prior to Day 2 subjects will have a brief appointment to review instructions for using the topography device. They will take the topography with them and be instructed to use it as they smoke ad-lib that evening at home. This will serve as a second practice session for getting used to the topography device. They will also be instructed to use the device for all cigarettes smoked upon awakening the next day at 6am (Day 2), including the first cigarette of the day. They will go to the study site for the first of three blood tests at 9:30 A.M, after which they will be allowed to leave the study site to continue with their daily activities. They will use the smoking topography device throughout the day, until 3 P.M. At this time, study staff will go to each participant's location to collect the device. Participants will have two additional blood tests over the course of the study to measure nicotine levels.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: CReSSmicro handheld topography deviceSmokers with schizophrenia |
| 2 | – | Device: CReSSmicro handheld topography deviceSmokers with bipolar disorder |
| 3 | – | Device: CReSSmicro handheld topography deviceSmokers without any mental illness |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be 100 smokers with schizophrenia, 100 smokers with bipolar disorder and 100 smokers without mental illness. This will include smokers within the New Jersey metropolitan area, who receive treatment at the UMDNJ-University Behavioral Health Care System (UBHC) or at another outpatient behavioral health care agency. A community sample of healthy volunteer smokers without mental illness will be recruited through advertisements to participate in the study.
Key inclusion criteria (6 listed)
- Meets DSM-IV diagnostic criteria for schizophrenia or bipolar I disorder
- Smokes 10 or more cigarettes every day
- Has been stable on current psychiatric medications for at least 1 month prior to study entry
- Smokes 10 or more cigarettes every day
Key exclusion criteria (20 listed)
- Current or past suicidal ideation, behavior, or suicide attempt within 30 days prior to study entry
- Psychiatric hospitalization within 30 days prior to study entry
- Inability to read English or inability to sufficiently understand study documents written in English
- Pregnant, breastfeeding, or plans to become pregnant within 1 month of study entry
- Current use of any non-cigarette forms of tobacco (e.g., cigars, pipes, smokeless tobacco, or ultralight cigarettes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CReSSmicro handheld topography deviceThe CReSS micro device represents the state-of-the-art technology for measurements of ambulatory puff topography taken in the smoker's natural environment. Although all topography measurements are limited, at least to some degree, by the artificial act of smoking while using a device, or smoking through a mouthpiece, this small, lightweight and portable device is easy to use outside of the laboratory setting to capture more naturalistic smoking behavior and allows for less intrusion from the research team and research environment. | Device | 1, 2, 3 |
Primary outcome
Smoking behavior and nicotine levels in those diagnosed with schizophrenia, those diagnosed with bipolar disorder and, those without a current mental illness
Time frame: Measured at Hour 24
1 secondary outcome
Difference in blood levels of cotinine in smokers with schizophrenia compared to controls
Time frame: Measured at Hour 24
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 27 May 2013.
- Results publication: PubMed 21596491Williams JM, Gandhi KK, Lu SE, Kumar S, Steinberg ML, Cottler B, Benowitz NL. Shorter interpuff interval is associated with higher nicotine intake in smokers with schizophrenia. Drug Alcohol Depend. 2011 Nov 1;118(2-3):313-9. doi: 10.1016/j.drugalcdep.2011.04.009. Epub 2011 May 18.
- Results publication: PubMed 20719908Williams JM, Gandhi KK, Benowitz NL. Carbamazepine but not valproate induces CYP2A6 activity in smokers with mental illness. Cancer Epidemiol Biomarkers Prev. 2010 Oct;19(10):2582-9. doi: 10.1158/1055-9965.EPI-10-0384. Epub 2010 Aug 18.
- Results publication: PubMed 20584771Williams JM, Gandhi KK, Lu SE, Kumar S, Shen J, Foulds J, Kipen H, Benowitz NL. Higher nicotine levels in schizophrenia compared with controls after smoking a single cigarette. Nicotine Tob Res. 2010 Aug;12(8):855-9. doi: 10.1093/ntr/ntq102. Epub 2010 Jun 28.
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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.
Jill M. Williams, MD principal investigator
Rutgers, The State University of New Jersey
Kunal K. Gandhi, MBBS, MPH study director
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 Schizophrenia and Bipolar Disorder, run by University of Medicine and Dentistry 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 6 inclusion and 20 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 27 May 2013. 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?
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?
Smoking behavior and nicotine levels in those diagnosed with schizophrenia, those diagnosed with bipolar disorder and, those without a current mental illness (time frame: Measured at Hour 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00382915, which also lists 3 linked publications.
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 27 May 2013.