Recruiting

Nicotine

Sponsor:

University of Vermont

Code:

NCT01216904

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

nicotine patch

placebo

Study Details

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

Study ID

NCT01216904

Start date

Oct, 2010

Status verified date

May, 2013

Completion date

Dec, 2013

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo patch

active comparator: Nicotine patch

Interventions

nicotine patch

7 mg patches to be worn for 16 hours per day

placebo

placebo patch to be worn 16 hours per day

Primary outcome measure

  • Stop Signal task [ Time Frame: 15 minutes ]

Central Contacts and Locations

Locations

Fletcher Allen Health Care/UVM

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Emily Houston

802-656-8974emily.houston@med.uvm.edu

Principal Investigator:

James Boyd, MD

More Information

Sponsor

University of Vermont

Last update posted

May 14, 2013

Last verified

May, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Vermont on 2013-05-14.