Treatment of non-motor symptoms of Parkinson's disease with Cannabidiol
- Conditions
- Chronic PainParkinson's Disease
- Registration Number
- RBR-3tvjjkx
- Lead Sponsor
- Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Over 25 years of age; Diagnosis of Parkinson's Disease according to Movement Disorder Society criteria; Present pain related to Parkinson's disease according to the criteria of the Parkinson Disease Pain Classification System Questionnaire; Suffer from chronic pain according to the definition of chronic pain recommended by the 11th edition of the International Classification of Diseases; Able to provide informed consent; Have easy access to a telephone
Allergy any component of the studied test solutions;Patients using medications with a narrow therapeutic index, and clinically relevant risk due to significant pharmacological interactions with medication studied; Clinically relevant current liver disease, at the discretion of the investigators, and/or hepatitis C; Concomitant use of valproic acid and/or its derivatives;
Personal history of schizophrenia and/or bipolar affective disorder; History of psychotic symptoms not justified by Parkinson's Disease; History of suicidal ideation, planning and/or attempt; Research subjects who will not be able to attend to the trial's follow-up assessments; Subjects who do not understand Portuguese; Women of childbearing age, unless they are using an Intrauterine Device or had been previously submitted to tubal ligation; Severe non-compensated psychiatric comorbidities, at the discretion of the researchers; Severe non-compensated clinical comorbidities, at the discretion of the researchers; Pregnant or breastfeeding women; Use in the past 2 years of Cannabis sp. and/or its derivatives for recreational or therapeutic purposes; Personal history of cannabis use disorder and/or other illicit drugs; Personal history of alcohol, tobacco, opioid, benzodiazepine, barbiturate and/or other substance use disorder
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method It is expected to find better pain control, verified using the Parkinson Disease Pain Classification System scale, from the identification of a variation in the mean score between the first and last evaluation.<br>
- Secondary Outcome Measures
Name Time Method