Clinical trial NCT01425684: Brain Circuits in Schizophrenia and Smoking
Official title: Brain Circuits in Schizophrenia and Smoking
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Keywords: MRI
Smoking
Schizophrenia
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-08-30
Enrollment: 837
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Smokers, nonsmokers, schizophrenia patients, family members

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.

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 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

Primary outcomes:
measure: 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
timeFrame: 12-15 hours
Secondary outcomes:
measure: Symptom and Cognition rating
timeFrame: 1-2 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine
state: Maryland
Study officials:
affiliation: Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine
name: L.Elliot Hong, M.D.
role: PRINCIPAL_INVESTIGATOR
References: