An observational study investigating the safety, tolerability and health outcomes of cannabinoid therapy prescribed to eligible patients for management of recognized chronic conditions

ABSTRACT: Interventions: This is an observational, single center investigator driven study conducted in Australia with patients who are about to start cannabinoid therapy for management of recognized chronic conditions. Patients are to be enrolled into the study no earlier than their Physician’s decision to initiate treatment with a cannabinoid therapy. It is mandatory that the prescriber’s decision to start treatment with cannabinoid therapy was taken independently and before presenting the patient the option to participate in the study. Participants will be followed monthly for a maximum of 12 months from the signing of the informed consent forms (PISCF) or until death, withdrawal of consent, loss of follow-up/record, whichever comes first. During the follow-up visits, assessments will be performed according to routine local clinical practice. Data collected at each visit for the study may include: - Change in concomitant medications and rationale - Kessler Psychological Distress Scale (K10) score - Insomnia Severity Index score - Simple Pain Index score - Kemp Quality of Life Scale score - Rationale for change in cannabinoid therapy and/or dose if applicable - Participant withdrawal from the study and/or reason for discontinuation of cannabinoid therapy - Adverse Events/Serious Adverse Events/Adverse Drug reaction that may have occurred while on the study Follow-up patient reports detailing the required information will be completed for a maximum of 12 months (Reports to coincide with patient visit for follow-up consultation and/or new cannabinoid therapy prescription). Primary outcome(s): The primary scientific objective of this project is to investigate the safety and tolerability characteristics of cannabinoid therapy prescribed to eligible patients for management of recognized chronic conditions. Safety and tolerability are measured through collection and reporting of adverse events. Information on severity, seriousness and relationship to medical cannabinoid treatment will be used to measure the tolerability and safety of any given dose. Like all prescription medicines, medicinal cannabis products can have side effects. These may include: - Fatigue and sedation - Vertigo - Nausea and vomiting - Fever - Appetite increase or decrease - Dry mouth - Diarrhoea - Convulsions - Feelings of euphoria (intense happiness) or depression confusion - Hallucinations or paranoid delusions - Psychosis or cognitive distortion (having untrue thoughts) Adverse event / serious adverse event data is collected at each visit through subject reporting of symptoms, collection of any relevant medical records / GP letters, and laboratory/pathology results. Adverse event information is documented via the observational trial specific adverse event log that is maintained by the treating physician. [Once a month for twelve months.];Participant withdrawal from the study and/or reason for discontinuation of cannabinoid therapy. This is assessed and reported by the treating physician at each visit via completion of observational trial worksheets and patient medical records. [Once a month for twelve months.];Number of doses consumed since previous visit (tolerability). This is assessed and reported by the treating physician at each visit via completion of observational trial worksheets and patient medical records [Once a month for twelve months.] Study Design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective

DISEASE(S): Neurological-parkinson's Disease,Anaesthesiology-pain Management,Neurological-other Neurological Disorders,Inflammatory Bowel Disease/irritable Bowel Syndrome,Neurological-epilepsy,Any Recognized Condition For Which Medicinal Cannabis Could Be Prescribed For,Mood Disorder,Mental Health-other Mental Health Disorders,Autism,Chemotherapy-induced Nausea And Vomiting,Insomnia,Mental Health-anxiety,Cancer-any Cancer,Neuropathic Pain,Post-traumatic Stress Disorder,Anxiety,Seizure Management/epilepsy,Parkinson's Disease/tremor,Chronic Pain,Dementia

PROVIDER: 23241 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR