Effects of Transdermal Nicotine on Response Inhibition to Emotional Cues in Schizophrenia
Schizophrenia, Impulsive Behavior
About this trial
This is an interventional basic science trial for Schizophrenia focused on measuring Nicotine, Nicotinic acetylcholine receptors, Schizophrenia, Schizoaffective disorder, Healthy control, Impulsive behavior, Aggression, Urgency
Eligibility Criteria
Inclusion Criteria for schizophrenia subjects:
- 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.
- Does not meet criteria for substance or alcohol use disorder per the SCID over the past 6 months
- For females, no longer of child-bearing potential, or agreeing to practice effective contraception during the study (e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device [IUD] or intrauterine system [IUS]; barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository; male partner sterilization; or true abstinence when this is in line with the preferred and usual lifestyle of the subject); and,
- For females of child-bearing potential, must have negative urine pregnancy test at time of screening visit and before each testing day.
- Not breastfeeding/nursing at time of screening or at any time during the study.
Exclusion Criteria for schizophrenia subjects:
- Age less than 18 or greater than 65.
- Not communicative in English.
- Unable to provide written informed consent.
- Active suicidal ideation or suicidal behavior.
- Current, unstable medical or neurological illness or significant abnormality on ECG.
- History of severe head trauma.
- BMI < 17.5 or > 45.
- History of allergy to transdermal patches.
- Screening visit resting heart rate > 110 or < 50 beats per minute, or known history of clinically significant cardiac rhythm abnormalities.
- Screening visit systolic blood pressure > 160 or < 90, or diastolic blood pressure > 95 or < 50.
- Positive urine toxicology or positive urine cotinine during screening.
- Meets criteria for diagnosis of substance or alcohol use disorder by SCID within the past 6 months.
- Reports any tobacco smoking or nicotine use over the past month.
- Not taking an antipsychotic medication.
- Positive urine pregnancy test at time of screening, before each testing day, or any potential concern for pregnancy at any time during the study
- Breastfeeding/nursing at time of screening or at any time during the study.
Inclusion Criteria for healthy volunteer subjects:
All of the above except for subjects will be psychiatrically healthy and not taking psychotropic or potentially psychoactive prescription medication.
Exclusion Criteria for healthy volunteer subjects:
All of the above and in addition:
- Current use of psychotropic or potentially psychoactive prescription medication.
- Major psychiatric disorder as determined by DSM-5 (schizophrenia, major depression, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder, etc.)
Sites / Locations
- Vanderbilt Psychiatric Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Healthy: placebo first, nicotine last
Healthy: nicotine first, placebo last
SCZ: placebo first, nicotine last
SCZ: nicotine first, placebo last
Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.
Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.
Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.
Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.