Brain Circuits in Schizophrenia and Smoking

NCT01425684 | Completed

• 2 other identifiers: HP-00045716R01DA027680
• Study Type: observational
• Target: 837
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Keywords

MRI; Smoking; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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

  12-15 hours

Secondary Outcomes (1)

• Symptom and Cognition rating

  1-2 hours

Study Arms (2)

schizophrenia

smokers and nonsmokers

control

smokers and nonsmokers

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Smokers, nonsmokers, schizophrenia patients, family members

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

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

Baltimore, Maryland, 21228, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Whole Blood * Saliva

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Smoking

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior

Study Officials

• L.Elliot Hong, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 28, 2011
• First Posted: August 30, 2011
• Study Start: December 20, 2010
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)