CompletedPhase 4

Naltrexone for Impulse Control Disorders in Parkinson's Disease

United States50 participantsStarted 2009-11

Plain-language summary

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

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

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

Timeframe: 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).

NCT IDNCT01052831

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12

Results submitted2015-03-10

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.