fMRI Study of Nicotinic Effect on Neurophysiology of Schizophrenia

Completed

Conditions studied: Schizophrenia, Psychopathology, Nicotine Dependence

In brief

Background: * Individuals who have schizophrenia are significantly more likely to smoke than the general population, which leads to increased smoking-related illnesses and high rates of nicotine dependence. Research suggests that high rates of smoking and nicotine addiction in people with schizophrenia are related to the fact that nicotine temporally improves performance in several cognitive tasks, including sensory gating, long-term memory, and visual tracking-all of which are affected by schizophrenia. * Smoking among schizophrenia patients may be a form of self-medication, since nicotine may temporarily treat and improve cognitive deficits caused by schizophrenia. Researchers are interested in studying the effects of nicotine on the brain activity of individuals with schizophrenia to better understand how nicotine affects the brain regions connected to memory, visual tracking, and attention. Objectives: * To identify specific brain regions involved in the anticipatory learning deficits found in schizophrenia patients who smoke. * To determine whether and how nicotine enhances performance in these regions. Eligibility: \- Smokers (at least 10 cigarettes per day) between 18 and 50 years of age who either are healthy volunteers or have been diagnosed with schizophrenia/schizoaffective disorder. Design: * Participants will be asked to avoid consuming alcohol and restrict consuming caffeinated beverages for 24 hours before the study days. Participants will provide urine and breath samples at the start of the study to be tested for chemicals that may interfere with the study. * The study will require two to four visits, with two fMRI sessions and other visits for a clinical interview or training. Participants will have a training session with a possible mock MRI scan to learn how to do tasks that track eye movement and measure ability to pay attention. * During the fMRI scanning sessions, participants will receive either a nicotine patch or a placebo patch without nicotine. After the patch is in place, participants will perform tasks while receiving MRI scans. The scans will take up to 2 hours. * Participants will provide blood samples after finishing the MRI sessions.

Key facts

Study ID

NCT01046526

Run by

National Institute on Drug Abuse (NIDA)

People needed

100

Starts

2005-02-08

Expected to finish

2012-05-03

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects will be excluded if they are unable to undergo MRI scanning due to pregnancy, implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobia. Subjects will also be excluded if they have 1) any major medical illnesses to include, but not limited to, uncontrolled high blood pressure or high blood sugar, cardiovascular disease, asthma, peripheral vascular diseases, coagulopathies, history of superficial or deep vein thrombosis, HIV, or other infectious diseases (e.g. Hepatitis B), 2) mood or anxiety disorders, or substance-induced psychiatric disorders, 3) neurological illnesses to include, but not limited to, seizure disorders, multiple sclerosis, movement disorders, or history of head trauma, CVA, CNS tumor, and other conditions that cause neurocognitive sequelae, 4) significant alcohol or other drug use, other than nicotine dependence, 5) if their T1 weighted images reveal gross structural abnormalities and/or, 6)have a history of syncope. Urine pregnancy tests will be performed on all female volunteers of child-bearing age before each experimental session. Subjects who are positive for any drug other than nicotine or marijuana will be excluded. Subjects in nicotine protocols may not be actively seeking or engaged in smoking cessation treatment. If a subject requires change of antipsychotic medications because of exacerbation of psychotic symptoms, the subject will be considered clinically unstable and his/her participation will be discontinued. Patients with Axis-I mood disorders or substance-induced psychiatric disorders are excluded. We also exclude patients with significant alcohol or other illicit drug use, other than nicotine dependence. This is operationally defined as no SCID/DSM-IV Axis-I substance dependence in the past 6 months, and no current substance abuse. Exceptions are occasional use of marijuana.

Where it is running

• Maryland Psychiatric Research Center (MPRC) 55 Wade Avenue — Catonsville, Maryland, United States

Full record on ClinicalTrials.gov

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