Nicotine Treatment of Impulsivity in Parkinson's Disease

NCT01216904 | Unknown Phase 4

• 1 other identifier: PSG PDF MCRA 07012010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 Disease subjects who have recently experienced an impulse control disorder.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Stop Signal task

  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.

  15 minutes

Secondary Outcomes (1)

• Set shifting task

  12-20 minutes

Study Arms (2)

Placebo patch

PLACEBO COMPARATOR

Drug: placebo

Nicotine patch

ACTIVE COMPARATOR

Drug: nicotine patch

Interventions

nicotine patch DRUG

7 mg patches to be worn for 16 hours per day

Also known as: Nicoderm patches

Nicotine patch

placebo DRUG

placebo patch to be worn 16 hours per day

Placebo patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Vermont: lead
• Parkinson's Disease Foundation: collaborator
• The Parkinson Study Group: collaborator

Study Sites (1)

Fletcher Allen Health Care/UVM

Burlington, Vermont, 05401, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• James Boyd, MD

  UVM/FAHC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 7, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 14, 2013

Record last verified: 2013-05

Locations

US (1)