Low-Dose Galantamine to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine

What Was Tested

This registered not phased trial tested Therapeutic nicotine (patch, non-peptide).

It had four arms (groups): Placebo patch and placebo capsule (experimental), Nicotine patch and placebo capsule (experimental), Placebo patch and galantamine capsule (experimental) and Nicotine patch and galantamine capsule (experimental).

On the double-placebo test day, participants receive a placebo patch and a placebo capsule.

The registry classes the interventions as drug.

More on the Plan

Healthy non-smokers will be screened for study eligibility and receive training on three different attention tasks.

The four test session are performed on separate days and take approximately 7 hours each.

During the first 5 hours, the participant may read or watch TV while nicotine and/or galantamine are being absorbed.

During the last two hours, the participant will perform the attention tasks on a computer.

Who Took Part

The registry lists 43 actual participants took part.

It was open to people of any sex aged from 21 years up to 55 years.

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

Examples of who could join: Aged 21 to 55 years. No exposure to any nicotine-containing product in the last year. Smoked no more that 40 cigarettes, cigars or cigarillos in lifetime. Normal or corrected to normal vision (at least 20/80). Body weight 110-220 lbs.

The full record lists 5 inclusion and 18 exclusion criteria; among the exclusions: pregnant or breast-feeding; drug or alcohol abuse or dependence currently or in the last 2 years; DSM Axis I mood, anxiety or psychotic disorder.

How the Study Was Run

Design: randomized, single-group and triple-blind.

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.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

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

It started in 2014-09 with completion listed for 2017-03.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Spatial Attentional Resource Allocation Task Predictive Trials Reaction Time (time frame: 45 min). Rapid Visual Information Processing Task Hit Rate (time frame: 30 min). Change Detection Task Accuracy (time frame: 15 min).

It also tracked 1 secondary outcome, for example Profile of Mood Scale - Total Mood Disturbance.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 43 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.