Status:
UNKNOWN
Nicotine Treatment of Impulsivity in Parkinson's Disease
Lead Sponsor:
University of Vermont
Collaborating Sponsors:
Parkinson's Disease Foundation
The Parkinson Study Group
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01216904
Start Date
October 1 2010
End Date
December 1 2013
Last Update
May 14 2013
Active Locations (1)
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1
Fletcher Allen Health Care/UVM
Burlington, Vermont, United States, 05401