Effects of Transdermal Nicotine on Response Inhibition to Emotional Cues in Schizophrenia (NCT03838484) | Clinical Trial Compass
TerminatedNot Applicable
Effects of Transdermal Nicotine on Response Inhibition to Emotional Cues in Schizophrenia
Stopped: Recruitment challenges due to Covid19.
United States18 participantsStarted 2019-05-10
Plain-language summary
The purpose of this study is to test whether nicotine, a drug that activates receptors called nicotinic acetylcholine receptors in the brain, improves the ability to make or withhold responses to faces that are either emotionally neutral or emotionally negative. This study will also test whether the drug affects brain activity while making or withholding responses using electroencephalography. Previous studies in people with schizophrenia have shown that more errors in response to negative emotional cues are related to greater likelihood of impulsive aggressive behavior. Therefore, the aim of this study is to determine whether nicotine might be a new strategy to reduce aggressive behavior. The investigators' goal is 25 individuals with schizophrenia and 25 healthy controls to complete the study at Vanderbilt.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Men and women age 18 - 65.
✓. Communicative in English.
✓. Provide voluntary, written informed consent.
✓. Physically healthy by medical history,and ECG examination.
✓. BMI \> 17.5 and \< 45.
✓. Diagnosis of schizophrenia (ICD-10 F20) or schizoaffective disorder (ICD-10 F25) confirmed by Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-V (SCID) or diagnostic interview with a trained clinician.
✓. Stable medication regimen over at least the past two weeks, including the use of either an oral or intramuscular administration of an antipsychotic medication. Additionally, subjects may take any prescribed medication aside from a nicotine-containing product as long as it has been regularly taken over the past two weeks, including as-needed ("PRN") medication.
✓. Negative urine toxicology and negative urine cotinine (to confirm no recent nicotine use) at screening.