NCT01046526

fMRI Study of Nicotinic Effect on Neurophysiology of Schizophrenia

Completed Last updated 2 July 2017

What this trial tests

trial in Schizophrenia in 100 participants. Completed in 3 May 2012.

Timeline

8 February 2005

3 May 2012

Quick facts

Lead sponsor	National Institute on Drug Abuse (NIDA)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	100
Start date	8 February 2005
Estimated completion	3 May 2012
Sites	1 location across United States

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →
• Psychopathology — all drugs for Psychopathology →
• Nicotine Dependence — all drugs for Nicotine Dependence →

Sponsor

National Institute on Drug Abuse (NIDA)

Who can join

Adults 18 to 50, any sex, with Schizophrenia or Psychopathology. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.