Overview
Nicotine Treatment of Impulsivity in Parkinson's Disease
Status:
Unknown status
Unknown status
Trial end date:
2013-12-01
2013-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of VermontCollaborators:
Parkinson's Disease Foundation
The Parkinson Study GroupTreatments:
Nicotine
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