Nicotine Treatment of Impulsivity in Parkinson's Disease

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: 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 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Vermont
• Collaborators: Parkinson's Disease Foundation; The Parkinson Study Group
• Treatments: 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