None listed
Conditions
Brief summary
The purpose of this study is to investigate the safety, tolerability and effectiveness of cannabinoid therapy prescribed to eligible patients for management of recognized chronic conditions using data reported by patients during treatment over a 12 month period.
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).
Sponsors
Eligibility
Inclusion criteria
1. Prospective participants must be greater than to equal to 18 years of age at time of entry on study 2. Prospective participants must be willing and able to understand the informed consent process, provide informed consent, and participate in the observational study 3. Prospective participants must be eligible to be lawfully prescribed cannabinoid therapy by their Physician 4. Prospective participants agree to abstain from using cannabinoid therapy other than the therapy that is prescribed by their Physician
Exclusion criteria
1. Prospective participants are ineligible if they are under the age of 18 2. Prospective participants are ineligible if they are unwilling, unable or cannot understand the informed consent form 3. Prospective participants are ineligible if their Physician determines that the prospective participant is unable to fulfill any requirements of the study 4. Prospective participants are ineligible if they are currently using illicit drugs and/or with alcohol abuse. 5. Prospective patients are ineligible if any of the following are met: 5.1. Have an active or previous psychotic or active mood or anxiety disorder 5.2. Women who are pregnant, planning to become pregnant or breastfeeding 5.3. Have unstable cardiovascular disease