Nicotine Treatment of Impulsivity in Parkinson's Disease

What Was Tested

This registered phase 4 trial tested Therapeutic nicotine (patch, non-peptide) for parkinson's disease.

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

The registry classes the interventions as drug.

More on the Plan

ICDs have a broad range of possible symptoms such as compulsive gambling, shopping, hypersexual behavior, overeating; spending excessive amounts of time on hobbies, tasks, or other organized activities; walking or driving without a goal or purpose; hoarding or overuse of PD medications.

ICDs are believed to occur due to effects of dopamine enhancing medications in areas of the brain which regulate behavior (rather than their intended target areas that regulate movement).

Acetylcholine is a chemical in the brain which works to regulate the effects of dopamine.

It has been known for many years that nicotine imitates many of the actions of acetylcholine.

Who Took Part

20 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Hoehn and Yahr19 stage 1 - 3 motor disability in the "on" medication state;. Stable PD and non-PD medications for at least 1 month prior to baseline;. Positive QUIP screening and confirmatory interview for current or prior ICD symptoms 36;. Montreal Cognitive Assessment score \> 24;. Impaired impulsive and/or compulsive responding compared to norms on Stop Signal Task and/or Set-Shifting Task.

The full record lists 14 inclusion and 8 exclusion criteria; among the exclusions: severe motor fluctuations;; prior dbs surgery;; uncontrolled hypertension (systolic bp\> 170 or diastolic bp\> 100);.

How the Study Was Run

Design: randomized, crossover and triple-blind.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

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

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

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

It started in 2010-10 with completion listed for 2013-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Stop Signal task (time frame: 15 minutes).

It also tracked 1 secondary outcome, for example Set shifting task.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 20 people with parkinson's disease.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, Parkinson's disease research.