Brain Circuits in Schizophrenia and Smoking

NCT ID: NCT01425684

Last Updated: 2021-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

837 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-20

Study Completion Date

2021-04-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Schizophrenia Schizoaffective Disorder Schizophreniform Disorder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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schizophrenia

smokers and nonsmokers

No interventions assigned to this group

control

smokers and nonsmokers

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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MPRC

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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L.Elliot Hong, M.D.

Role: PRINCIPAL_INVESTIGATOR

Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine

Locations

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Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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R01DA027680

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HP-00045716

Identifier Type: -

Identifier Source: org_study_id

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