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Brain Circuits in Schizophrenia and Smoking

This study is currently recruiting participants.
Verified August 2017 by MPRC, University of Maryland
Sponsor:
ClinicalTrials.gov Identifier:
NCT01425684
First Posted: August 30, 2011
Last Update Posted: August 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
MPRC, University of Maryland
  Purpose
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.

Condition
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Brain Circuits in Schizophrenia and Smoking

Resource links provided by NLM:


Further study details as provided by MPRC, University of Maryland:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Symptom and Cognition rating [ Time Frame: 1-2 hours ]

Biospecimen Retention:   Samples With DNA
  • Whole Blood
  • Saliva

Estimated Enrollment: 800
Study Start Date: January 2011
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
schizophrenia
smokers and nonsmokers
control
smokers and nonsmokers

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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Smokers, nonsmokers, schizophrenia patients, family members
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425684


Contacts
Contact: L.Elliot Hong, M.D. 410-402-6828 ehong@mprc.umaryland.edu

Locations
United States, Maryland
Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine Recruiting
Baltimore, Maryland, United States, 21228
Contact: Caroline Silva, MSW    410-402-6126    csilva@mprc.umaryland.edu   
Sponsors and Collaborators
University of Maryland
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: L.Elliot Hong, M.D. Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine
  More Information

Responsible Party: MPRC, Associate Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01425684     History of Changes
Other Study ID Numbers: HP-00045716
R01DA027680 ( U.S. NIH Grant/Contract )
First Submitted: August 28, 2011
First Posted: August 30, 2011
Last Update Posted: August 4, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by MPRC, University of Maryland:
MRI
Smoking
Schizophrenia

Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders