Nicotine Treatment of Impulsivity in Parkinson's Disease
Recruitment status was Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Nicotine Treatment of Impulsivity in Parkinson's Disease: A Pilot Study|
- Stop Signal task [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]The Stop Signal Task is best described as a laboratory measure of inhibitory control. The task itself requires quick execution of a thought or action, and the occasional inhibition of this behavior. On the computerized task subjects are asked to respond as fast as they can to symbols (ex. letters) presented on a computer screen.
- Set shifting task [ Time Frame: 12-20 minutes ] [ Designated as safety issue: No ]It has been considered a measure of executive function because of its reported sensitivity to frontal lobe dysfunction. As such, the WCST allows the clinician to assess the following "frontal" lobe functions: strategic planning, organized searching, utilizing environmental feedback to shift cognitive sets, directing behavior toward achieving a goal, and modulating impulsive responding.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo patch||
placebo patch to be worn 16 hours per day
|Active Comparator: Nicotine patch||
Drug: nicotine patch
7 mg patches to be worn for 16 hours per day
Other Name: Nicoderm patches
In recent years, a group of behavior changes collectively called Impulse Control Disorders (ICDs) have been identified in Parkinson's Disease (PD). 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. It is estimated that as many as 30% of people with PD experience ICDs during the course of their condition. 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).
A reduction or discontinuation of PD medications can be helpful in reducing ICDs. Unfortunately reduction in medication is often impractical or not possible because people with PD rely on these medications to improve their movement symptoms. There are currently no scientifically proven treatments for ICDs except for PD medication reductions.
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. In preliminary studies, nicotine has been shown to reduce impulsive behavior in Attention Deficit Hyperactivity Disorder. By administering nicotine across the skin using a patch, we hope to better understand whether nicotine may act to improve impulse control disorders in PD without needing to reduce or stop PD medications. Several studies have shown that nicotine is tolerated well by people with PD, and does not appear to worsen motor/movement symptoms. The amount of nicotine in each patch used in this study is the same as patches that are used in people who are trying to quit smoking.
In this pilot within-subject crossover placebo-controlled study, subjects with a diagnosis of Parkinson's Disease who have recently experiencing an impulse control disorder will be enrolled. Subjects will randomized to one of two treatment groups. During the first portion of the study, the first treatment group will receive transdermal nicotine (nicotine by skin patch) and the second treatment group will receive an identical placebo patch which does not contain any nicotine. Over the course of the study, each of the two groups will switch to receive whichever treatment they were not initially receiving (for example-the first treatment group will later receive the placebo patch and the second treatment group will later receive the nicotine patch). Each treatment group will receive the nicotine patch or placebo patch for an equal number of weeks, but at different times during the study. Clinical and laboratory computer based measurements of impulsive and compulsive behaviors, memory testing, sleep quality/ sleepiness, and Parkinson's disease symptoms will be assessed at each visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216904
|United States, Vermont|
|Fletcher Allen Health Care/UVM||Recruiting|
|Burlington, Vermont, United States, 05401|
|Contact: Emily Houston 802-656-8974 firstname.lastname@example.org|
|Principal Investigator: James Boyd, MD|
|Principal Investigator:||James Boyd, MD||UVM/FAHC|