SchizophreniaNCT01425684
Brain Circuits in Schizophrenia and Smoking
An observational study of Schizophrenia and Schizoaffective Disorder, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The principle aim of the project is to identify the key brain circuits associated with smoking and especially smoking in high risk population. The investigators hope that the study will provide concrete biomarkers for new therapeutic development and ultimately reducing the smoking related health burden. Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
- How many people
- 837 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2010to Apr 2021
- 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 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Smokers, nonsmokers, schizophrenia patients, family members
Who may be able to join
- Male and Female between ages 12-above (clinical assessments and blood draw only above 62)
- Ability to give written assent (age below 18)
- Ability to give written informed consent (age 18 or above)
- Individuals fulfilled other criteria but over age 62, with major medical illnesses, significant alcohol or other drug use, or unable to undergo MRI may participate in clinical assessments and blood draw if his/her participation forms a family unit (i.e., if at least one of the family member has participated).
- Subjects above age 62 will not participate in MRI measurements although they may still participate in clinical assessments and blood draw.
Who cannot join
- Inability to sign informed consent/assent
- For patient participants, Evaluation to Sign Consent (ESC) below 10.
- Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, repeated seizure, history of significant head trauma, CNS infection or tumor, other significant brain neurological conditions.
- Significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence.
- Woman who are pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive urine pregnancy test before MRI)
- Can not refrain from using alcohol and/or marijuana 24 hours or more prior to experiments.
- For MRI, unable to undergo MRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobic to the scanner
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine
Baltimore, Maryland, 21228
About this study
The principle aim of the project is to identify the key brain circuits associated with smoking and especially smoking in high risk population. The investigators hope that the study will provide concrete biomarkers for new therapeutic development and ultimately reducing the smoking related health burden.
Read the detailed description
There are several studies and hypotheses to be tested. This project includes (1) a cross-sectional study design that measures brain imaging, smoking, clinical diagnosis and symptoms, cognitive functional assessments, distress tolerance, and genetic information, which is also the baseline for the longitudinal study; and (2) a longitudinal study design for smoking cessation option for 1 year in some smokers and a longitudinal follow-up for all available subjects.
During the baseline portion of the study, subjects are expected to complete clinical symptom assessments, a computer challenge task to measure distress tolerance, MRI scan, role-play test to measure cognitive and functional abilities, and blood draw. Subjects who are eligible will participate in the longitudinal follow-up study where the research team will call subjects regularly regarding smoking related information (smoking risk and treatment options).
- Keywords
- MRI, Smoking, Schizophrenia
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Smoking
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 |
|---|---|---|
| schizophrenia | smokers and nonsmokers | |
| control | smokers and nonsmokers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine addiction severity is associated with abnormal functional connectivity as measured by fMRI,compared with nonsmokers.Schizophrenia pts are assoc with add'l functional connectivity impairment compared with controls
Measured: 12-15 hours
Secondary outcomes (1)
Symptom and Cognition rating
Measured: 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study start20 Dec 2010
- Primary completionApr 2021
- Study completionApr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 837 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, MPRC, University of Maryland, Baltimore
- Investigators
- L.Elliot Hong, M.D., Principal investigator, Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425684
- Sponsor's protocol ID
- HP-00045716
- Other IDs
- R01DA027680
- Status last verified
- Apr 2021
- First submitted
- 28 Aug 2011
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Circuits in Schizophrenia and Smoking
- ClinicalTrials.gov ID
- NCT01425684
- Acronym / sponsor ID
- HP-00045716
- Keywords
- MRI, Smoking, Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 837 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 20 Dec 2010 (actual)
- Primary completion
- Apr 2021 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 30 Aug 2011 (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.
The principle aim of the project is to identify the key brain circuits associated with smoking and especially smoking in high risk population. The investigators hope that the study will provide concrete biomarkers for new therapeutic development and ultimately reducing the smoking related health burden.
Detailed description
There are several studies and hypotheses to be tested. This project includes (1) a cross-sectional study design that measures brain imaging, smoking, clinical diagnosis and symptoms, cognitive functional assessments, distress tolerance, and genetic information, which is also the baseline for the longitudinal study; and (2) a longitudinal study design for smoking cessation option for 1 year in some smokers and a longitudinal follow-up for all available subjects.
During the baseline portion of the study, subjects are expected to complete clinical symptom assessments, a computer challenge task to measure distress tolerance, MRI scan, role-play test to measure cognitive and functional abilities, and blood draw. Subjects who are eligible will participate in the longitudinal follow-up study where the research team will call subjects regularly regarding smoking related information (smoking risk and treatment options).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| schizophrenia | – | –smokers and nonsmokers |
| control | – | –smokers and nonsmokers |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Smokers, nonsmokers, schizophrenia patients, family members
Key inclusion criteria (5 listed)
- Male and Female between ages 12-above (clinical assessments and blood draw only above 62)
- Ability to give written assent (age below 18)
- Ability to give written informed consent (age 18 or above)
- Individuals fulfilled other criteria but over age 62, with major medical illnesses, significant alcohol or other drug use, or unable to undergo MRI may participate in clinical assessments and blood draw if his/her participation forms a family unit (i.e., if at least one of the family member has participated).
- Subjects above age 62 will not participate in MRI measurements although they may still participate in clinical assessments and blood draw.
Key exclusion criteria (7 listed)
- Inability to sign informed consent/assent
- For patient participants, Evaluation to Sign Consent (ESC) below 10.
- Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, repeated seizure, history of significant head trauma, CNS infection or tumor, other significant brain neurological conditions.
- Significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence.
- Woman who are pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive urine pregnancy test before MRI)
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
Nicotine addiction severity is associated with abnormal functional connectivity as measured by fMRI,compared with nonsmokers.Schizophrenia pts are assoc with add'l functional connectivity impairment compared with controls
Time frame: 12-15 hours
1 secondary outcome
Symptom and Cognition rating
Time frame: 1-2 hours
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 3 May 2021.
- Individual participant dataSharing planned: No
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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.
L.Elliot Hong, M.D. principal investigator
Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine
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 Schizoaffective Disorder, run by University of Maryland, Baltimore 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 5 inclusion and 7 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 3 May 2021. 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?
Nicotine addiction severity is associated with abnormal functional connectivity as measured by fMRI,compared with nonsmokers.Schizophrenia pts are assoc with add'l functional connectivity impairment compared with controls (time frame: 12-15 hours). 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 3 May 2021.