Clinical Trial: Naltrexone for Impulse Control Disorders in Parkinson's Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized, Double-blind, Placebo-controlled Study of Naltrexone for Impulse Control Disorders in Parkinson's Disease
Brief Summary: This study will evaluate the effectiveness of naltrexone in reducing ICD symptoms in Parkinson's disease patients taking a dopamine agonist.
Detailed Summary:
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.
Sponsor: University of Pennsylvania
Current Primary Outcome: Percentage of Participants Assessed as Very Much Improved or Much Improved Based on the Clinical Global Impression-Improvement (CGI-I) Scale [ 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). ]
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.
Original Primary Outcome: Clinical Global Impression-Improvement (CGI-I) score [ Time Frame: The CGI-I will be administed at visits 1, 2, 3 (phone), and 4 ]
Current Secondary Outcome: Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS) [ Time Frame: The QUIP-RS was administered at baseline and the termination visits (Visit 5, 8 weeks after baseline). ]
Original Secondary Outcome:
- Treatment Emergent Symptom Scale (TESS) [ Time Frame: The TESS will be administered at visits 1, 2, 3 (phone), and 4. ]
- 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 ]
Information By: University of Pennsylvania
Dates:
Date Received: January 15, 2010
Date Started: November 2009
Date Completion:
Last Updated: July 13, 2015
Last Verified: July 2015
