Nicotine Effects on Endophenotypes of Schizophrenia

What Was Tested

The trial (not phased) is built around Therapeutic nicotine (patch, non-peptide).

The purpose of this study is to test the effects of nicotine on cognition with the following schizophrenia endophenotypes: prepulse inhibition, antisaccades, the continuous performance test, spatial working memory and a verbal memory task.

Schizophrenia patients, unaffected first-degree relatives of schizophrenia patients and healthy controls receive transdermal nicotine in a double-blind, placebo-controlled, crossover study.

It had two arms (groups): Nicotine Patch (active comparator) and Placebo patch (placebo comparator).

Transdermal nicotine patch.

Placebo patch.

The registry classes the interventions as drug.

More on the Plan

The present study aims to investigate how nicotine affects attentional and executive schizophrenia endophenotypes and how genetic polymorphisms relating to the cholinergic system might play a role in inter-individual differences in the magnitude of nicotine effects.

Schizophrenia patients, first-degree relatives of schizophrenia patients as well as healthy controls will receive transdermal nicotine in a double-blind, placebo-controlled, crossover study and will be assessed with prepulse inhibition, antisaccades, the continuous performance test, spatial working memory and a verbal memory task.

Subjects will be overnight-abstinent smokers and non-smokers.

However, the investigators will particularly test non-smokers in order to eliminate confounding effects of nicotine withdrawal and reinstatement.

Who Took Part

121 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) diagnosis of schizophrenia. Age 18-55 years old. Able to provide informed consent. Normal or corrected to normal vision. Smokers (Fagerström Test for Nicotine Dependence \> 4).

The full record lists 14 inclusion and 35 exclusion criteria; among the exclusions: substance dependence; clinical instability; changes in medication in the last 6 weeks.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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

In the crossover set-up each of the participants took both Therapeutic nicotine (patch, non-peptide) and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

Those kept unaware of assignments: participant and investigator.

It started in 2008-07 with completion listed for 2012-03.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Error Percentage in Antisaccade Task (time frame: Three hours after patch application).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 121 people.

The trial is marked completed; 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.