Cannabis fOr Management of Pain: Assessment of Safety Study: COMPASS

1. Adverse events and adverse drug reactions*:
Time of measurement: this will be reported by the subjects during interviews at clinic visits, during telephone contacts, or at any time by calling the local study nurse up to one year
2. Neurocognitive tests (Wechsler scales, for experimental arm [cannabis users] and control arm [non-cannabis users]):
Time of measurement: baseline, six months and one year

*An "adverse event" means any adverse occurrence in the health of a clinical trial subject who is administered a drug, which may or may not be caused by the administration of the drug, and includes an adverse drug reaction. An "Adverse Drug Reaction (ADR)" means any noxious and unintended response to a drug that is caused by the administration of any dose of the drug.

1. Satisfaction with the study drug: a global rating of change in patient satisfaction with the provided drug will be generated for subjects and physicians using the Clinician's Global Impression of Change (CGIC) scale. This is an observational scale of global evaluation, which assesses the changes in degree of illness in relation to the original assessment, not just due to the study drug. The scale has only one item that measures global change of the illness (improvement or worsening) by the clinician and by the patients, separately, on a seven-point scale from zero to six. Change in satisfaction on this scale will also be examined with other measures of satisfaction such as dropout rates

Time of measurement:
Experimental arm (cannabis users): one month, two months, three months, six months, nine months, one year
Control arm (non-cannabis users): six months, one year

2. Effects on symptoms and quality of life:
a. Pain intensity: effects on pain intensity will be recorded using 0 to 10 numerical rating scales (0: no pain, 10: worst)
b. McGill Pain Questionnaire (MPQ): pain quality will be recorded using the MPQ. The MPQ is a self-administered questionnaire that evaluates the sensory, affective, and evaluative dimensions of pain and provides global scores and subscale scores for each of these dimensions
c. Edmonton Symptom Assessment Scale (ESAS): other symptoms will be monitored using the validated ESAS. The ESAS evaluates eight symptoms on visual analogue scores
d. Profile of Mood States (POMS): the POMS was developed to assess transient distinct mood states and has become the most popular and widely used tool to assess mood
e. Quality of life will be followed using the 36-item Short Form health survey (SF-36): SF-36 is a generic measure of perceived health status that incorporates behavioural functioning, subjective well-being and perceptions of health by assessing eight health concepts

Time of measurement:
Experimental arm (cannabis users): baseline, one month, two months, three months, six months, nine months, one year
Control arm (non-cannabis users): baseline, six months, one year

3. Feasibility of web-based adverse event reporting: will be assessed by ongoing documentation of the study monitoring process, specifically recording the issues that may arise during data collection using web-based forms (errors, misunderstandings, etc.,) and the manner and success of their resolution