Brain Circuits in Schizophrenia and Smoking

Schizophrenia Clinical Trial

Official title:

Brain Circuits in Schizophrenia and Smoking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425684
• Other study ID #: HP-00045716
• Secondary ID: R01DA027680
• Status: Completed
• Start date: December 20, 2010
• Est. completion date: April 2021

Study information

• Verified date: April 2021
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 837
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder

Locations

Country	Name	City	State
United States	Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Symptom and Cognition rating		1-2 hours