None listed
Conditions
Brief summary
The purpose of this study is to investigate the safety, tolerability and effectiveness of pharmaceutical grade cannabis for the management of pain. Who is it for? You may be eligible for this study if you are an adult who has been prescribed NanaBis™ for either cancer-related or non-cancer related pain. Study details All participants will be followed up by their doctors on a monthly basis for 12 months. These follow ups will involve completion of surveys and provision of information regarding the administration of NanaBis™. Participants will not be asked to undergo any procedures or tests as part of this study. It is hoped that this study will help determine whether pharmaceutical grade cannabis is an options for pain management.
Interventions
This is an observational, multicentre study conducted in Australia with patients who are about to start a therapy with NanaBis™ for the management of cancer related or non-cancer related pain. Patients are to be enrolled into the study no earlier than the Consenting Doctor’s decision to initiate treatment with NanaBis™. It is mandatory that the prescriber’s decision to start treatment with NanaBis™ was taken independently and before the decision to give the patient the option to participate in the study. Consenting Doctors' clinics will be asked to progressively enrol eligible patients until the maximum inclusion threshold is reached. Participants will be followed monthly for a maximum of 12 months from the signing of the informed consent or until death, withdrawal of consent, loss of follow-up/record, whichever comes first. During the follow-up visits (which will take approximately 15-20 minutes) assessments will be performed according to routine local clinical practice. De-identified data collected at each visit and reported to the Sponsor must include the information listed under ‘Study Procedures’. Follow-up de-identified patient reports detailing the required information will be sent to the Sponsor for a maximum of 12 months (Reports to coincide with patient visit for follow-up consultation and/or new NanaBis™ prescription).
Sponsors
Eligibility
Inclusion criteria
1. Prospective participants greater than or equal to 18 years of age at time of entry on study; 2. Prospective participants have the cognitive ability to understand the informed consent process and to give informed consent to participate in the observational study; 3. Prospective participants have been lawfully prescribed NanaBis™ by their Consenting Doctor; 4. Prospective participants are prescribed NanaBis™ for the management of cancer related or non-cancer related pain; 5. Prospective participants are able to visit the Consenting Doctor as required while administering NanaBis™ and are able to provide information as required to the Consenting Doctor for the duration of the study; 6. Prospective participants agree to abstain from using cannabis products other than NanaBis™ for the duration of their participation in the study.
Exclusion criteria
Exclusion criteria: 1. Prospective participants will be ineligible if they are under the age of 18 years; 2. Prospective participants will be ineligible if they are unwilling or unable to sign the Informed Consent Form or cannot understand the Participant Information Sheet provided; 3. Prospective participants will be ineligible if the Consenting Doctor determines that the prospective participant is unable to fulfill any of the requirements of the study; 4. Prospective participants will be ineligible if they are unwilling or unable to perform study procedures as described in the study protocol. 5. Prospective participants will be ineligible if they are currently using Illicit drugs and/or with alcohol abuse.