Nicotine Treatment of Impulsivity in Parkinson's Disease

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT01216904

Run by

University of Vermont

People needed

20

Starts

2010-10-01

Expected to finish

2013-12-01

Last updated by the study team

2013-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fletcher Allen Health Care/UVM — Burlington, Vermont, United States (enrolling)

Full record on ClinicalTrials.gov

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