Naltrexone for Impulse Control Disorders in Parkinson's Disease

NCT ID: NCT01052831

Last Updated: 2015-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-12-31

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.

Conditions

Impulse Control Disorder; Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Naltrexone

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.

Group Type: ACTIVE_COMPARATOR

Naltrexone

Intervention Type: DRUG

50-100 mg qd for 8 weeks

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

50-100 mg qd for 8 weeks

Interventions

Naltrexone

50-100 mg qd for 8 weeks

Intervention Type: DRUG

Placebo

50-100 mg qd for 8 weeks

Intervention Type: DRUG

Other Intervention Names

Revia, Vivitrol

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of possible or probable idiopathic Parkinson's disease (PD).

2. Ages 18-85 years.

3. Diagnosis of compulsive gambling, buying, sex behavior, or eating of >2 months duration.

4. Impulse control disorder (ICD) behaviors that began after PD onset and in context of dopamine agonist (DA) treatment.

5. 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.

6. Subjects are capable of giving informed consent, supported by not having significant cognitive impairment based on Montreal Cognitive Assessment score ≥24.

7. Willingness to maintain existing PD pharmacotherapy regimen for the duration of the study.

Exclusion Criteria

1. Active suicide ideation.

2. 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).

3. ICD behaviors so severe that modification of DA treatment is clinically warranted, as judged by PI.

4. Deep brain stimulation surgery in the past year.

5. Evidence for significant liver disease by chart review or patient history (e.g., cirrhosis, chronic hepatitis, liver transplant, or liver cancer).

6. Meeting diagnostic criteria for alcohol or opiate dependence.

7. Meeting diagnostic criteria for Dopamine Dysregulation Syndrome.

8. Use of opioids for pain management.

9. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Daniel Weintraub

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Weintraub, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25037206 (View on PubMed)

Other Identifiers

810624

Identifier Type: -

Identifier Source: org_study_id