Observational Study of the Safety, Tolerability and Efficacy of Cannabidiol Oro-buccal Sprays for Treating Pain and/or Stress

This observational study will involve a systematic examination of participants who have been prescribed either botanical extract CBD (MC-1020) and synthetic CBD (MC-1023), which are delivered as oro-buccal sprays. The decision by a Participating Doctor to prescribe MC-1020 or MC-1023 for pain and/or stress for a patient will be taken independently and before the decision to give the patient the option to participate in the current study. The study treatments are comprised of botanical extract CBD (MC-1020) and synthetic CBD (MC-1023), which are delivered as oro-buccal sprays. The design of this study incorporates Doctor and Pharmacist Combined Care, this statement is reflective of both doctors and pharmacists being involved in the collection of study data, rather than a novel model of care that is being examined. De-identified digital reports collected by the online digital platform, C-Trial, using HTTPS encryption and secure storage on an Amazon cloud service with multifactor authentication protected access. Each month participants will log in to C-Trial (a purpose-built electronic data capture platform) and complete online questionnaires. The participant will be provided with an electronic report to complete containing the following baseline information will be recorded by the participant before being supplied with the study treatment, history of smoking, alcohol, and drug use (including cannabis), current medicinal or recreational cannabis. Participant reports: monthly, the anticipated time needed to complete these reports each month is 20 minutes, no additional testing/ imaging is required of participants. The overall duration of participant observation is monthly from enrolment for up to 24 months post enrolment. Participating Doctor and Participating Pharmacist induction reports include the following baseline information, History of smoking, alcohol, and drug use (including cannabis), study product indication (stress and/or pain), current and past medical history, including any mental health conditions, current medications including medicinal or recreational cannabis (concurrent medicinal or recreational cannabinoid use is excluded from this study). Follow-Up Report the Participating Pharmacist will provide information on the study treatment current dose, changes in dosing since the last report, the rationale for changes in dosing, and planned duration of treatment. Any other cannabinoid use (medicinal or recreational; concurrent medicinal or recreational cannabinoid use is excluded from this study) and changes in other medications used for the study indication and rationale for changes in dosing. The participant will be provided with an electronic follow-up report to complete on a monthly basis after induction; as well as 2 weeks after induction; daily for three days after cessation of treatment; and 2 weeks after cessation of treatment. The reports will provide the following information on their current dose, changes, the rationale for changes in dosing of the study treatment and changes in other medications. Follow-up visits with the Participating Doctor are not required unless severe or serious adverse reactions occur. For any follow-up visit that does occur (such as provision of study treatment continuation scripts), assessments will be performed and the Participating Doctor will complete forms including prescribed dose and rationale for changes in dosing of the study treatment, changes in other medications, and follow up on any adverse events. The Participant and the Participating Pharmacist will receive an email and/or SMS when their respective reports are open to being completed. If a Participant or Participating Pharmacist report has remained uncompleted for 3 working days, the Participant or Participating Pharmacist will receive a reminder email and/or SMS. If a Participant is not assessed by the Participating Pharmacist within the month a Participating Pharmacist Follow-Up Report must be submitted.