Cannabis For Cancer-Related Symptoms

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  19 and up

Participation Criteria

Inclusion Criteria:

* At least 19 years of age;
* Competent to consent to participation in the study;
* Must have at least one of the following cancer-related symptoms or a cancer treatment-related symptoms which is causing distress: Nausea; Pain; Anxiety; Sleep Disturbance; (based on ESAS-r-SN score ≥4/10)
* Symptom(s) are expected to be stable throughout the duration of the study;
* Expecting to live for at least 4 months;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2;
* Willing to commit to not taking cannabis in any form other than the study products for the duration of the study;
* Able to reliably communicate with the research team, either directly or through a translator;
* Accessible by telephone.

Exclusion Criteria:

* Their current symptoms are not related to cancer or cancer treatment;
* They have a current cannabis or other substance dependence or misuse disorder as defined by the revised Cannabis Use Disorder Identification Test (CUDIT-R) score of 8 or above;
* They admit to cannabis use for any purpose (recreational or medicinal) more than once a week during the month prior to study entry;
* They have a history of psychosis with, or other intolerance to cannabis or cannabinoids;
* They have an active psychiatric disorder likely, in the investigator's opinion, to interfere with adherence to study protocol;
* They have any concurrent condition likely to interfere with completion of the study protocol, such as allergy to any component of the study products;
* They are pregnant or planning to get pregnant or they are lactating females;
* They are women of childbearing potential (\<2 years after last menstruation) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal);
* They have reproductive potential and fail to use adequate birth control;
* They are on another clinical trial or expect to start one prior to study completion;
* They have oral disease which might impair trans-mucosal absorption, e.g. oral mucositis;
* They are taking medications that might be affected by an interaction with cannabinoids in a clinically significant manner (CYP1A1, 1A2, and 1B1) and cannot be switched to a different medication;
* They live in an environment with high risk of theft or diversion of study products;
* They have a concurrent condition that requires changes to current medications within the 48 days on study treatment.
* They have serious cardiovascular disease such as ischemic heart disease, including arrhythmias, poorly controlled hypertension, severe heart failure, recent (within 6 months) MI.
* They have first degree relatives with schizophrenia.
* They have history of epilepsy or repeated seizures or brain metastases.
* They are unable or unwilling to refrain from operating heavy machinery for the duration of their participation in this study.
* They are unable or unwilling to refrain from consuming alcohol for the duration of their participation in this study.
* They expect to leave Canada during the study period, as the study products cannot be taken across any international border (land, sea or air).