A Phase 4 interventional study of Naltrexone and Placebo in Impulse Control Disorder and Parkinson Disease, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-08-06.
Sponsored by University of Pennsylvania · Phase 4, Interventional, and Treatment
This study will evaluate the effectiveness of naltrexone in reducing ICD symptoms in Parkinson's disease patients taking a dopamine agonist.
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.
4,488 studies on the registry are indexed under Parkinson Disease; 1,083 are open to participants now.
This study's enrollment of 50 is above the median of 40 across 3,295 interventional studies indexed under Parkinson Disease.
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Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
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Exclusion Criteria
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.
Drug: Naltrexone
Participants received the placebo treatment which looked identical to active study medication.
Drug: Placebo
50-100 mg qd for 8 weeks
Also known as: Revia, Vivitrol
50-100 mg qd for 8 weeks
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: 1. = Very much improved 2. = Much improved 3. = Minimally improved 4. = No change 5. = Minimally worse 6. = Much worse 7. = 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.
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).
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.
Time frame: The QUIP-RS was administered at baseline and the termination visits (Visit 5, 8 weeks after baseline).
| Milestone | Naltrexone | Placebo |
|---|---|---|
| Started | 26 | 24 |
| Completed | 22 | 23 |
| Not completed | 4 | 1 |
The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale: 1. = Very much improved 2. = Much improved 3. = Minimally improved 4. = No change 5. = Minimally worse 6. = Much worse 7. = 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.
| percentage of responders | Naltrexone | Placebo |
|---|---|---|
| Percentage of Participants Assessed as Very Much Improved or Much Improved Based on the Clinical Global Impression-Improvement (CGI-I) Scale | 54.4 | 33.1 |
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.
| Change in points on a scale (QUIP-RS) | Naltrexone | Placebo |
|---|---|---|
| Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS) | 14.92 (9.89 to 19.96) | 7.55 (2.45 to 12.66) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Naltrexone | — | 0/24 (0%) | 18/24 (75%) |
| Placebo | — | 0/24 (0%) | 14/24 (58.3%) |
| Event | Naltrexone | Placebo |
|---|---|---|
| Blood Pressure ChangeGeneral disorders | 6/24 | 10/24 |
| NauseaGastrointestinal disorders | 7/24 | 0/24 |
| HeadacheNervous system disorders | 5/24 | 4/24 |
| DizzinessGeneral disorders | 4/24 | 1/24 |
| Age, Continuous(years) | Naltrexone | Placebo | Total |
|---|---|---|---|
| Mean | 61.3 ± 9.0 | 61.0 ± 8.2 | 61.2 ± 8.5 |
| Sex: Female, Male(Participants) | Naltrexone | Placebo | Total |
|---|---|---|---|
| Female | 10 | 18 | 28 |
| Male | 16 | 6 | 22 |
| Ethnicity (NIH/OMB)(Participants) | Naltrexone | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 26 | 23 | 49 |
| Unknown or Not Reported | 0 | 0 | 0 |
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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University of Pennsylvania