Parkinson's DiseasePhase 4NCT01216904
Nicotine Treatment of Impulsivity in Parkinson's Disease
A Phase 4 study testing nicotine patch in people with Parkinson's Disease, run by University of Vermont at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- nicotine patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Fletcher Allen Health Care/UVM
Burlington, Vermont, 05401
Emily Houston, 802-656-8974, emily.houston@med.uvm.edu
James Boyd, MD
About this study
Official title: Nicotine Treatment of Impulsivity in Parkinson's Disease: A Pilot Study
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.
Read the 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 compulsive gambling, shopping, hypersexual behavior, overeating; spending excessive amounts of time on hobbies, tasks, or other organized activities; walking or driving without a goal or purpose; hoarding or overuse of PD medications. It is estimated that as many as 30% of people with PD experience ICDs during the course of their condition. ICDs are believed to occur due to effects of dopamine enhancing medications in areas of the brain which regulate behavior (rather than their intended target areas that regulate movement).
A reduction or discontinuation of PD medications can be helpful in reducing ICDs. Unfortunately reduction in medication is often impractical or not possible because people with PD rely on these medications to improve their movement symptoms. There are currently no scientifically proven treatments for ICDs except for PD medication reductions.
Acetylcholine is a chemical in the brain which works to regulate the effects of dopamine. It has been known for many years that nicotine imitates many of the actions of acetylcholine. In preliminary studies, nicotine has been shown to reduce impulsive behavior in Attention Deficit Hyperactivity Disorder. By administering nicotine across the skin using a patch, we hope to better understand whether nicotine may act to improve impulse control disorders in PD without needing to reduce or stop PD medications. Several studies have shown that nicotine is tolerated well by people with PD, and does not appear to worsen motor/movement symptoms. The amount of nicotine in each patch used in this study is the same as patches that are used in people who are trying to quit smoking.
In this pilot within-subject crossover placebo-controlled study, subjects with a diagnosis of Parkinson's Disease who have recently experiencing an impulse control disorder will be enrolled. Subjects will randomized to one of two treatment groups. During the first portion of the study, the first treatment group will receive transdermal nicotine (nicotine by skin patch) and the second treatment group will receive an identical placebo patch which does not contain any nicotine. Over the course of the study, each of the two groups will switch to receive whichever treatment they were not initially receiving (for example-the first treatment group will later receive the placebo patch and the second treatment group will later receive the nicotine patch). Each treatment group will receive the nicotine patch or placebo patch for an equal number of weeks, but at different times during the study. Clinical and laboratory computer based measurements of impulsive and compulsive behaviors, memory testing, sleep quality/ sleepiness, and Parkinson's disease symptoms will be assessed at each visit.
- Conditions
- Parkinson's Disease
- Being tested
- nicotine patch, placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nicotine patchDrug
Also called Nicoderm patches
7 mg patches to be worn for 16 hours per day
placeboDrug
placebo patch to be worn 16 hours per day
| Study group | Role | What they receive |
|---|---|---|
| Placebo patch | Placebo comparator | Not described Receives: Drug: placebo |
| Nicotine patch | Active comparator | Not described Receives: Drug: nicotine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes
Secondary outcomes (1)
Set shifting task
It has been considered a measure of executive function because of its reported sensitivity to frontal lobe dysfunction. As such, the WCST allows the clinician to assess the following "frontal" lobe functions: strategic planning, organized searching, utilizing environmental feedback to shift cognitive sets, directing behavior toward achieving a goal, and modulating impulsive responding.
Measured: 12-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinson's Disease Foundation, The Parkinson Study Group
- Responsible party
- Principal investigator, James BOYD MD, University of Vermont
- Investigators
- James Boyd, MD, Principal investigator, UVM/FAHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216904
- Sponsor's protocol ID
- PSG PDF MCRA 07012010
- Status last verified
- May 2013
- First submitted
- 6 Oct 2010
- Last updated
- 14 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Treatment of Impulsivity in Parkinson's Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT01216904
- Acronym / sponsor ID
- PSG PDF MCRA 07012010
- Conditions
- Parkinson's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Parkinson's Disease Foundation, The Parkinson Study Group
- Study start
- Oct 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 7 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 compulsive gambling, shopping, hypersexual behavior, overeating; spending excessive amounts of time on hobbies, tasks, or other organized activities; walking or driving without a goal or purpose; hoarding or overuse of PD medications. It is estimated that as many as 30% of people with PD experience ICDs during the course of their condition. ICDs are believed to occur due to effects of dopamine enhancing medications in areas of the brain which regulate behavior (rather than their intended target areas that regulate movement).
A reduction or discontinuation of PD medications can be helpful in reducing ICDs. Unfortunately reduction in medication is often impractical or not possible because people with PD rely on these medications to improve their movement symptoms. There are currently no scientifically proven treatments for ICDs except for PD medication reductions.
Acetylcholine is a chemical in the brain which works to regulate the effects of dopamine. It has been known for many years that nicotine imitates many of the actions of acetylcholine. In preliminary studies, nicotine has been shown to reduce impulsive behavior in Attention Deficit Hyperactivity Disorder. By administering nicotine across the skin using a patch, we hope to better understand whether nicotine may act to improve impulse control disorders in PD without needing to reduce or stop PD medications. Several studies have shown that nicotine is tolerated well by people with PD, and does not appear to worsen motor/movement symptoms. The amount of nicotine in each patch used in this study is the same as patches that are used in people who are trying to quit smoking.
In this pilot within-subject crossover placebo-controlled study, subjects with a diagnosis of Parkinson's Disease who have recently experiencing an impulse control disorder will be enrolled. Subjects will randomized to one of two treatment groups. During the first portion of the study, the first treatment group will receive transdermal nicotine (nicotine by skin patch) and the second treatment group will receive an identical placebo patch which does not contain any nicotine. Over the course of the study, each of the two groups will switch to receive whichever treatment they were not initially receiving (for example-the first treatment group will later receive the placebo patch and the second treatment group will later receive the nicotine patch). Each treatment group will receive the nicotine patch or placebo patch for an equal number of weeks, but at different times during the study. Clinical and laboratory computer based measurements of impulsive and compulsive behaviors, memory testing, sleep quality/ sleepiness, and Parkinson's disease symptoms will be assessed at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo patch | Placebo comparator | Drug: placebo |
| Nicotine patch | Active comparator | Drug: nicotine patch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nicotine patchAlso: Nicoderm patches7 mg patches to be worn for 16 hours per day | Drug | Nicotine patch |
| placeboplacebo patch to be worn 16 hours per day | Drug | Placebo patch |
Primary outcome
Stop Signal task
Time frame: 15 minutes
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.
1 secondary outcome
Set shifting task
Time frame: 12-20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Boyd, MD principal investigator
UVM/FAHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nicotine patch in people with Parkinson's Disease, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stop Signal task (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2013.