Trial Details

Not Recruiting
Basic Information
Clinical ID c2213
Identifier ACTRN12623000149662
Trial Title An observational study investigating the safety, tolerability and health outcomes of cannabinoid therapy prescribed to eligible patients for management of recognized chronic conditions
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions Any recognized condition for which medicinal cannabis could be prescribed for;Chronic Pain;Anxiety ;Insomnia;Post-traumatic stress disorder;Dementia;Parkinson's disease/Tremor;Seizure management/Epilepsy;Neuropathic pain;Mood Disorder ;Autism ;Inflammatory bowel disease/Irritable bowel syndrome;Chemotherapy-induced nausea and vomiting; Any recognized condition for which medicinal cannabis could be prescribed for Chronic Pain Anxiety Insomnia Post-traumatic stress disorder Dementia Parkinson's disease/Tremor Seizure management/Epilepsy Neuropathic pain Mood Disorder Autism Inflammatory bowel disease/Irritable bowel syndrome Chemotherapy-induced nausea and vomiting;Anaesthesiology - Pain management;Mental Health - Anxiety;Neurological - Epilepsy;Mental Health - Other mental health disorders;Neurological - Parkinson's disease;Neurological - Other neurological disorders;Cancer - Any cancer
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 decision to initiate treatment with a cannabinoid therapy. It is mandatory that the prescriber 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).
Participant Information
Sponsor Cloud Medical PTY LTD
City -
Country/Region Australia
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, ELDER, OLDER_ADULT
Study Design
Study Type Observational
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -