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

What Was Tested

In this not phased trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

This study will also test whether the drug affects brain activity while making or withholding responses using electroencephalography.

It had four arms (groups): one (experimental), one (experimental), SCZ: placebo first, nicotine last (experimental) and SCZ: nicotine first, placebo last (experimental).

The registry classes the interventions as drug.

More on the Plan

Nicotinic acetylcholine receptors are a large family of excitatory, pentameric, ionotropic, ligand-gated ion channels located throughout the brain and the remainder of the body.

Their endogenous ligand is acetylcholine, yet this family is defined by their common activation by nicotine.

Urgency is a behavioral construct defined as the tendency to act rashly in the context of strong positive or negative emotion, and explains a large degree of variance in the development of impulsive aggression in subjects with schizophrenia and other populations without psychiatric disorders.

In patients with schizophrenia, degree of urgency correlates with structural and functional changes in a neuronal network involving prefrontal cortical and limbic/cognitive control brain regions.

Who Took Part

18 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Men and women age 18 - 65. Communicative in English. Provide voluntary, written informed consent. 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.

The full record lists 12 inclusion and 18 exclusion criteria; among the exclusions: age less than 18 or greater than 65; not communicative in english; unable to provide written informed consent.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

Each person switched between Therapeutic nicotine (patch, non-peptide) and the comparison at some point, usually with a gap in between.

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-05-10 with completion listed for 2020-02-24.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: False Alarm Error Rate (time frame: Week 1). False Alarm Error Rate (time frame: Week 2). Omission Error Rate (time frame: Week 1).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 18 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.