The Effects of Nicotine on Cognition in Schizophrenia

What Was Tested

This registered phase 4 trial tested Therapeutic nicotine (patch, non-peptide).

The purpose of this study is to investigate the effects of nicotine on cognition in schizophrenia.the researchers will evaluate the effects of transdermal nicotine compared with placebo for attentional impairments in non-smokers with schizophrenia and controls.

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

The registry classes the interventions as drug.

More on the Plan

This is an add-on study, subjects will continue with their usual medications and treatments throughout.

Subjects are randomized to one of 2 groups for order of receiving active and placebo patch, using a computer generated random number sequence.

Randomization is concealed using opaque envelopes.

Assessors and subjects are blind to group allocation.

Who Took Part

60 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: DSM IV diagnosis of schizophrenia,. Age 18 - 60 inclusive,. Able to provide informed consent,. Not treated with an investigational medication in the past 30 days,. WRAT-3 IQ raw score greater than or equal to 35,.

The full record lists 18 inclusion and 19 exclusion criteria; among the exclusions: use of any nicotine containing product in the past 3 months by self report,; use of cholinesterase inhibitors such as galantamine in the past 3 months,; untreated ischaemic heart disease,.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 and investigator.

It started in 2004-04 with completion listed for 2009-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Attention Measured by the Continuous Performance Test Identical Pairs Version (time frame: Visit 1 and visit 2 (separated by an interval of 7-10 days)).

It also tracked 3 secondary outcomes, for example Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Letter Number Sequencing.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 60 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.