Nicotine Treatment of Impulsivity in Parkinson's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Vermont
Sponsor:
Collaborators:
Parkinson's Disease Foundation
The Parkinson Study Group
Information provided by (Responsible Party):
James BOYD MD, University of Vermont
ClinicalTrials.gov Identifier:
NCT01216904
First received: October 6, 2010
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

The specific aims of this study are to examine whether treatment with transdermal nicotine improves computer-based laboratory and clinical measures of impulsive and compulsive behaviors in Parkinson's Disease subjects who have recently experienced an impulse control disorder.


Condition Intervention Phase
Parkinson's Disease
Drug: nicotine patch
Drug: placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
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)
Arms Assigned Interventions
Placebo Comparator: Placebo patch Drug: placebo
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A clinical diagnosis of idiopathic Parkinson's Disease based on movement disorders specialist assessment using the National Institute of Neurological disorders and Stroke (NINDS) criteria 17;
  • demonstrated response to L-¬DOPA and/or dopamine agonists;
  • 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
  • Global Deterioration Scale score24 of 1-2;
  • Adequate visual and auditory acuity for neuropsychological testing;
  • good general health with no additional diseases expected to interfere with the study;
  • normal laboratory tests and ECG;
  • female participants must be non-breastfeeding, post-menopausal or have been surgically sterilized or have a negative urine pregnancy test at screening and baseline visits with an acceptable form of contraception being used (see drug safety section for details on acceptable contraception);
  • Subjects will be taking no centrally active or anti or pro-cholinergic drugs;
  • non¬smokers, defined as no cigarettes in the last 6 months

Exclusion Criteria:

  • severe motor fluctuations;
  • prior DBS surgery;
  • Any significant systemic illness or unstable medical condition including serious heart disease, severe asthma, severe or active ulcer disease, active thyroid disease, pyloric stenosis epilepsy, or allergies to nicotine;
  • clinically significant laboratory test abnormalities on the battery of screening tests (hematology, chemistry, urinalysis, ECG);
  • uncontrolled hypertension (systolic BP> 170 or diastolic BP> 100);
  • Any current significant or unstable depression, anxiety, or psychosis
  • history of obsessive-compulsive disorder
  • use of any investigational drugs within 30 days or 5 half-¬lives, whichever is longer, prior to screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216904

Locations
United States, Vermont
Fletcher Allen Health Care/UVM Recruiting
Burlington, Vermont, United States, 05401
Contact: Emily Houston    802-656-8974    emily.houston@med.uvm.edu   
Principal Investigator: James Boyd, MD         
Sponsors and Collaborators
University of Vermont
Parkinson's Disease Foundation
The Parkinson Study Group
Investigators
Principal Investigator: James Boyd, MD UVM/FAHC
  More Information

No publications provided

Responsible Party: James BOYD MD, Assistant Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT01216904     History of Changes
Other Study ID Numbers: PSG PDF MCRA 07012010
Study First Received: October 6, 2010
Last Updated: May 10, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014