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Naltrexone for Impulse Control Disorders in Parkinson's Disease

Primary Purpose

Impulse Control Disorder, Parkinson Disease

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Naltrexone

Placebo

About this trial

This is an interventional treatment trial for Impulse Control Disorder focused on measuring Compulsive Gambling, Compulsive Buying, Compulsive Shopping, Compulsive Eating, Hypersexuality, Dopamine Agonists, Mirapex, Pramipexole, Requip, Ropinirole, Impulse Control Disorders

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Naltrexone

Placebo

Arm Description

For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.

Participants received the placebo treatment which looked identical to active study medication.

Outcomes

Primary Outcome Measures

Percentage of Participants Assessed as Very Much Improved or Much Improved Based on the Clinical Global Impression-Improvement (CGI-I) Scale

The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale: = Very much improved = Much improved = Minimally improved = No change = Minimally worse = Much worse = Very much worse A participant scoring a 1 or 2 is considered a responder on the CGI scale. For the change in response status over time, a generalized estimating equation (GEE) model was used.

Secondary Outcome Measures

Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)

The Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) was developed for use in clinical trials and added as a secondary outcome measure for assessment of change in severity of ICD symptoms, to be completed at baseline and end of study only. For the QUIP-RS, scores for each compulsive behavior range from 0 to 16, with a higher score indicating greater severity (frequency) of symptoms. Given that ICD symptoms are frequently comorbid in patients with PD, total QUIP-RS ICD scores (range from 0 to 64) were used to compare overall severity of ICD symptoms. Please note that this measure is reporting a change from baseline.

Full Information

NCT ID

NCT01052831

First Posted

January 15, 2010

Last Updated

July 13, 2015

Sponsor

University of Pennsylvania

Collaborators

Michael J. Fox Foundation for Parkinson's Research

1. Study Identification

Unique Protocol Identification Number

NCT01052831

Brief Title

Naltrexone for Impulse Control Disorders in Parkinson's Disease

Official Title

Randomized, Double-blind, Placebo-controlled Study of Naltrexone for Impulse Control Disorders in Parkinson's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pennsylvania

Collaborators

Michael J. Fox Foundation for Parkinson's Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impulse Control Disorder, Parkinson Disease

Keywords

Compulsive Gambling, Compulsive Buying, Compulsive Shopping, Compulsive Eating, Hypersexuality, Dopamine Agonists, Mirapex, Pramipexole, Requip, Ropinirole, Impulse Control Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Naltrexone

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants received the placebo treatment which looked identical to active study medication.

Intervention Type

Drug

Intervention Name(s)

Naltrexone

Other Intervention Name(s)

Revia, Vivitrol

Intervention Description

50-100 mg qd for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

50-100 mg qd for 8 weeks

Primary Outcome Measure Information:

Title

Percentage of Participants Assessed as Very Much Improved or Much Improved Based on the Clinical Global Impression-Improvement (CGI-I) Scale

Description

Time Frame

The CGI-I was administered at Visit 2 (week 2, two weeks after baseline) and Visit 5 (week 8, termination visit 8 weeks after baseline).

Secondary Outcome Measure Information:

Title

Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)

Description

Time Frame

The QUIP-RS was administered at baseline and the termination visits (Visit 5, 8 weeks after baseline).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Weintraub, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25037206

Citation

Papay K, Xie SX, Stern M, Hurtig H, Siderowf A, Duda JE, Minger J, Weintraub D. Naltrexone for impulse control disorders in Parkinson disease: a placebo-controlled study. Neurology. 2014 Aug 26;83(9):826-33. doi: 10.1212/WNL.0000000000000729. Epub 2014 Jul 18.

Results Reference

result

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Naltrexone for Impulse Control Disorders in Parkinson's Disease

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