View Clinical Trial (Medical Research Study)
Brain Circuits in Schizophrenia and Smoking
| City: |
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Baltimore |
| State: |
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Maryland |
| Zip Code: |
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21228 |
| Conditions: |
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Schizophrenia - Schizoaffective Disorder - Schizophreniform Disorder |
| Purpose: |
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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.
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| Study Summary: |
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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).
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| Criteria: |
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Inclusion Criteria:
- Male and Female between ages 14-62 (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.
Exclusion Criteria:
- 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
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| NCT ID: |
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NCT01425684 |
| Primary Contact: |
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Principal Investigator
L.Elliot Hong, M.D.
Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Med
L.Elliot Hong, M.D.
Phone: 410-402-6828
Email: ehong@mprc.umaryland.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Baltimore, Maryland 21228
United States
Kavita Thangavelu, MSW
Phone: 410-402-6124
Email: Kthangavelu@mprc.umaryland.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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