Effects of Transdermal Nicotine on Response Inhibition to Emotional Cues in Schizophrenia

• Status: Terminated
• Trial end date: 2020-02-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Collaborators: National Institute of Mental Health (NIMH); University of Florida
• Treatments: Nicotine

Criteria

Inclusion Criteria for schizophrenia subjects:

1. Men and women age 18 - 65.

2. Communicative in English.

3. Provide voluntary, written informed consent.

4. Physically healthy by medical history,and ECG examination.

5. BMI > 17.5 and < 45.

6. 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.

7. 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.

8. Negative urine toxicology and negative urine cotinine (to confirm no recent nicotine use) at screening.

9. Does not meet criteria for substance or alcohol use disorder per the SCID over the past 6 months

10. 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,

11. For females of child-bearing potential, must have negative urine pregnancy test at time of screening visit and before each testing day.

12. Not breastfeeding/nursing at time of screening or at any time during the study.

Exclusion Criteria for schizophrenia subjects:

1. Age less than 18 or greater than 65.

2. Not communicative in English.

3. Unable to provide written informed consent.

4. Active suicidal ideation or suicidal behavior.

5. Current, unstable medical or neurological illness or significant abnormality on ECG.

6. History of severe head trauma.

7. BMI < 17.5 or > 45.

8. History of allergy to transdermal patches.

9. Screening visit resting heart rate > 110 or < 50 beats per minute, or known history of clinically significant cardiac rhythm abnormalities.

10. Screening visit systolic blood pressure > 160 or < 90, or diastolic blood pressure > 95 or < 50.

11. Positive urine toxicology or positive urine cotinine during screening.

12. Meets criteria for diagnosis of substance or alcohol use disorder by SCID within the past 6 months.

13. Reports any tobacco smoking or nicotine use over the past month.

14. Not taking an antipsychotic medication.

15. Positive urine pregnancy test at time of screening, before each testing day, or any potential concern for pregnancy at any time during the study

16. 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:

1. Current use of psychotropic or potentially psychoactive prescription medication.

2. Major psychiatric disorder as determined by DSM-5 (schizophrenia, major depression, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder, etc.)