Naltrexone for Impulse Control Disorders in Parkinson's Disease - Full Text View

Sponsor:	University of Pennsylvania
Collaborator:	Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):	Daniel Weintraub, University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT01052831

Purpose

This study will evaluate the effectiveness of naltrexone in reducing ICD symptoms in Parkinson's disease patients taking a dopamine agonist.

Condition	Intervention	Phase
Impulse Control Disorders in Parkinson's Disease	Drug: Naltrexone	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized, Double-blind, Placebo-controlled Study of Naltrexone for Impulse Control Disorders in Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Perry syndrome

MedlinePlus related topics: Compulsive Gambling Parkinson's Disease

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

Clinical Global Impression-Improvement (CGI-I) score [ Time Frame: The CGI-I will be administed at visits 1, 2, 3 (phone), and 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Treatment Emergent Symptom Scale (TESS) [ Time Frame: The TESS will be administered at visits 1, 2, 3 (phone), and 4. ] [ Designated as safety issue: Yes ]
One or more of the following will be administered as needed: Gambling Symptom Assessment Scale, Buying Questionnaire, Sexual Compulsivity Scale, Compulsive Eating Scale [ Time Frame: Administered at baseline and visits 2 and 4 ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	November 2009
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Naltrexone Participants will receive Naltrexone	Drug: Naltrexone 50-100 mg qd for 8 weeks
Placebo Comparator: Placebo Participants will receive placebo treatment	Drug: Naltrexone 50-100 mg qd for 8 weeks

Detailed Description:

Impulse control disorders (ICDs), including compulsive gambling, sexual behavior, buying, and eating, are increasingly recognized as a significant clinical problem in Parkinson's disease (PD), occurring in up to 15% of patients. Dopamine agonist (DA) treatment is thought to be the primary risk factor for the development of ICDs in PD. ICDs often lead to significant impairments in psychosocial functioning, interpersonal relationships, and quality of life. The management of ICDs in the context of PD can be complex. Patients may be reluctant to discontinue DA treatment due to the motor benefits derived from treatment, so patients often have chronic symptoms. Thus, additional treatment approaches are needed.

A medication shown to be efficacious for the treatment of ICDs with minimal impact on parkinsonism would allow many ICD patients to continue on full-dose DA treatment. Naltrexone, a long-acting opioid receptor antagonist, helps in the treatment of alcohol and opioid dependence. In addition, placebo-controlled studies have demonstrated that it helps in the treatment of pathological gambling in the general population. Opioids regulate dopamine pathways in areas of the brain linked with impulse control disorders, and opioid antagonists block opioid receptors in these regions. In this study, 48 PD patients with an ICD will be treated either with naltrexone (50-100 mg/day) or placebo for a period of 8 weeks. The study will assess if naltrexone improves ICD symptoms in PD and is well tolerated. To our knowledge, the proposed study is the first controlled trial of an agent to treat ICDs in PD.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Diagnosis of possible or probable idiopathic Parkinson's disease (PD).
Ages 18-85 years.
Diagnosis of compulsive gambling, buying, sex behavior, or eating of >2 months duration.
Impulse control disorder (ICD) behaviors that began after PD onset and in context of dopamine agonist (DA) treatment.
Current stable DA use. Participants must be on a DA for 6 months and on a stable dose (no changes) for 1 month prior to enrolling the in the study.
Subjects are capable of giving informed consent, supported by not having significant cognitive impairment based on Montreal Cognitive Assessment score ≥24.
Willingness to maintain existing PD pharmacotherapy regimen for the duration of the study.

Exclusion Criteria

Active suicide ideation.
Anticipated need to initiate antidepressant therapy during the course of the study (must be on a dose in the therapeutic range for at least 2 months. If patient does end up needing to start antidepressant or change antidepressant dose during the course of the study, he/she will be allowed to continue study participation).
ICD behaviors so severe that modification of DA treatment is clinically warranted, as judged by PI.
Deep brain stimulation surgery in the past year.
Evidence for significant liver disease by chart review or patient history (e.g., cirrhosis, chronic hepatitis, liver transplant, or liver cancer).
Meeting diagnostic criteria for alcohol or opiate dependence.
Meeting diagnostic criteria for Dopamine Dysregulation Syndrome.
Use of opioids for pain management.
Females that are pregnant, planning to become pregnant, or are breastfeeding will not be included in the study. Females of child bearing potential will need to verify that they are not pregnant by a negative urine pregnancy test.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052831

Contacts

Contact: Kimberly A Papay, BS	215-349-8390	Kimberly.Papay@uphs.upenn.edu
Contact: Eugenia Mamikonyan, MS	215-615-3085	Eugenia.Mamikonyan@uphs.upenn.edu

Locations

United States, Pennsylvania
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Daniel Weintraub, MD 215-349-8207 Daniel.Weintraub@uphs.upenn.edu

Sponsors and Collaborators

University of Pennsylvania

Michael J. Fox Foundation for Parkinson's Research

Investigators

Principal Investigator:

Daniel Weintraub, MD

University of Pennsylvania

More Information

Publications:

Weintraub D. Dopamine and impulse control disorders in Parkinson's disease. Ann Neurol. 2008 Dec;64 Suppl 2:S93-100.

Responsible Party:	Daniel Weintraub, Associate Professor, University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT01052831 History of Changes
Other Study ID Numbers:	810624
Study First Received:	January 15, 2010
Last Updated:	November 14, 2011
Health Authority:	United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

Compulsive Gambling
Compulsive Buying
Compulsive Shopping
Compulsive Eating
Hypersexuality
Dopamine Agonists

Mirapex
Pramipexole
Requip
Ropinirole
Impulse Control Disorders

Additional relevant MeSH terms:

Impulse Control Disorders
Parkinson Disease
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders

Neurodegenerative Diseases
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2012