Schizophrenia and Disorders With Psychotic FeaturesNCT00135772
Nicotine and Cotinine Levels in Smokers With Schizophrenia and Schizoaffective Disorder - 2
An observational study of Schizophrenia and Disorders With Psychotic Features and Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Nicotine dependence is very common among individuals with schizophrenia and schizoaffective disorder. Cotinine is a chemical that is made by the body from nicotine. Measuring levels of nicotine and cotinine is an accurate way to determine how much cigarette smoke enters a person's body. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia and Disorders With Psychotic Features, Tobacco Use Disorder
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Jul 2004
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meets DSM-IV diagnostic criteria for nicotine dependence and possibly schizophrenia or schizoaffective disorder
- Stable on current antipsychotic regimen(s) for participants with schizophrenia or schizoaffective disorder
Who cannot join
- At serious risk of suicide, including recent suicidal behavior or attempt within the thirty days prior to study entry
- Current use of clonidine, bupropion, or any other nicotine products (including nicotine patch, gum, inhaler, lozenge or nasal spray)
Trial locations and contacts
1 site in 1 country.
United States1 site
UMDNJ - Robert Wood Johnson Medical School
Piscataway, New Jersey, 08854
About this study
Official title: Nicotine and Cotinine Levels in Smokers With Schizophrenia and Schizoaffective Disorder
Nicotine dependence is very common among individuals with schizophrenia and schizoaffective disorder. Cotinine is a chemical that is made by the body from nicotine. Measuring levels of nicotine and cotinine is an accurate way to determine how much cigarette smoke enters a person's body. The purpose of this study is to measure nicotine and cotinine levels in smokers with schizophrenia or schizoaffective disorder to determine if such individuals absorb more nicotine per cigarette than smokers without schizophrenia-related disorders.
Read the detailed description
Schizophrenic individuals have higher urinary cotinine levels compared to non-schizophrenic individuals with a similar smoking history. This suggests that schizophrenic individuals may absorb higher doses of nicotine. The purpose of this study is to determine whether smokers with schizophrenia or schizoaffective disorder have higher serum nicotine and cotinine levels in comparison to smokers without schizophrenic-related disorders.
This observational, case-control study will enroll 150 participants, of which 100 will be smokers with schizophrenic-related disorders and 50 will be smokers without a mental illness. Upon completing baseline assessments, participants will smoke a single cigarette. Approximately two minutes following, 3 to 4 ounces of blood will be analyzed for nicotine and cotinine levels. An expired carbon monoxide reading will also be measured. This measurement correlates with the amount of smoke inhalation. Individual participant studies will be completed in 1 to 2 hour-long sessions.
- Keywords
- nicotine dependence
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders, Tobacco Use Disorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startOct 2003
- Primary completionJul 2004
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia and Disorders With Psychotic FeaturesStudies 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
- Time perspective
- Prospective
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jill M. Williams, M.D., Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135772
- Sponsor's protocol ID
- NIDA-14009-2
- Other IDs
- K23-14009-2, DPMC
- Status last verified
- Aug 2008
- First submitted
- 23 Aug 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
Publications
Williams JM, Ziedonis DM, Abanyie F, Steinberg ML, Foulds J, Benowitz NL. Increased nicotine and cotinine levels in smokers with schizophrenia and schizoaffective disorder is not a metabolic effect. Schizophr Res. 2005 Nov 15;79(2-3):323-35. doi: 10.1016/j.schres.2005.04.016. Epub 2005 Jun 14.
PubMed 15961287Williams JM, Gandhi KK, Steinberg ML, Foulds J, Ziedonis DM, Benowitz NL. Higher nicotine and carbon monoxide levels in menthol cigarette smokers with and without schizophrenia. Nicotine Tob Res. 2007 Aug;9(8):873-81. doi: 10.1080/14622200701484995.
PubMed 17654300
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine and Cotinine Levels in Smokers With Schizophrenia and Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00135772
- Acronym / sponsor ID
- NIDA-14009-2
- Keywords
- nicotine dependence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Oct 2003
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 26 Aug 2005 (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.
Nicotine dependence is very common among individuals with schizophrenia and schizoaffective disorder. Cotinine is a chemical that is made by the body from nicotine. Measuring levels of nicotine and cotinine is an accurate way to determine how much cigarette smoke enters a person's body. The purpose of this study is to measure nicotine and cotinine levels in smokers with schizophrenia or schizoaffective disorder to determine if such individuals absorb more nicotine per cigarette than smokers without schizophrenia-related disorders.
Detailed description
Schizophrenic individuals have higher urinary cotinine levels compared to non-schizophrenic individuals with a similar smoking history. This suggests that schizophrenic individuals may absorb higher doses of nicotine. The purpose of this study is to determine whether smokers with schizophrenia or schizoaffective disorder have higher serum nicotine and cotinine levels in comparison to smokers without schizophrenic-related disorders.
This observational, case-control study will enroll 150 participants, of which 100 will be smokers with schizophrenic-related disorders and 50 will be smokers without a mental illness. Upon completing baseline assessments, participants will smoke a single cigarette. Approximately two minutes following, 3 to 4 ounces of blood will be analyzed for nicotine and cotinine levels. An expired carbon monoxide reading will also be measured. This measurement correlates with the amount of smoke inhalation. Individual participant studies will be completed in 1 to 2 hour-long sessions.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meets DSM-IV diagnostic criteria for nicotine dependence and possibly schizophrenia or schizoaffective disorder
- Stable on current antipsychotic regimen(s) for participants with schizophrenia or schizoaffective disorder
Key exclusion criteria (2 listed)
- At serious risk of suicide, including recent suicidal behavior or attempt within the thirty days prior to study entry
- Current use of clonidine, bupropion, or any other nicotine products (including nicotine patch, gum, inhaler, lozenge or nasal spray)
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
Not reported in the source record.
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 12 Jan 2017.
- Results publication: PubMed 15961287Williams JM, Ziedonis DM, Abanyie F, Steinberg ML, Foulds J, Benowitz NL. Increased nicotine and cotinine levels in smokers with schizophrenia and schizoaffective disorder is not a metabolic effect. Schizophr Res. 2005 Nov 15;79(2-3):323-35. doi: 10.1016/j.schres.2005.04.016. Epub 2005 Jun 14.
- Results publication: PubMed 17654300Williams JM, Gandhi KK, Steinberg ML, Foulds J, Ziedonis DM, Benowitz NL. Higher nicotine and carbon monoxide levels in menthol cigarette smokers with and without schizophrenia. Nicotine Tob Res. 2007 Aug;9(8):873-81. doi: 10.1080/14622200701484995.
Related trials for Schizophrenia and Disorders With Psychotic Features
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
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, M.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 Schizophrenia and Disorders With Psychotic Features and Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) 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 2 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 12 Jan 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00135772, which also lists 2 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 12 Jan 2017.