Naltrexone for Impulse Control Disorders in Parkinson's Disease
Condition: Impulse Control Disorder; Parkinson Disease
MeSH terms: Parkinson Disease; Disruptive, Impulse Control, and Conduct Disorders
Intervention: Naltrexone; Placebo
Intervention description: 50-100 mg qd for 8 weeks; 50-100 mg qd for 8 weeks
Intervention MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Compulsive Gambling; Compulsive Buying; Compulsive Shopping; Compulsive Eating; Hypersexuality; Dopamine Agonists; Mirapex; Pramipexole; Requip; Ropinirole; Impulse Control Disorders

Summary:

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

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.