Medicinal cannabis use among dementia patients

This study is a parallel mixed methods design that includes a randomised, double blinded, crossover, N-of-1, placebo-control trial. This is similar to a phase II randomised control trial: Arm 1: Placebo Arm 2: Medicinal Cannabis oil This trial will run for 16 weeks. In a crossover design a number of treatment cycles occur where each participant will receive the placebo and the medicinal cannabis oil during one treatment cycle. This trial will include two, six-week treatment cycles. For the first six week treatment cycle, participants will be randomised into the placebo group (Arm 1) or medicinal cannabis oil (Arm 2) group. After the first six week treatment cycle, a two-week washout period will occur. During the second treatment cycle those who took the medicinal cannabis oil (Arm 2) in the first treatment cycle will take the placebo (Arm 1) during the second treatment cycle and vis versa. After the second treatment cycle, an additional two-week washout period will occur to monitor the participants as they will no longer be taking any additional medication. The 16 week will comprise of two, six-week treatment cycles, with a two, two-week wash out periods. The mode of administration will be through an oral spray. The dose, will be increased from 2.5mg/day (1 spray) until the participant reaches their best, tolerated dose or a maximum of 50mg/day (20 sprays). The dose will be increased approximately every three days and on the days the dose has been increased, the resident will record the presence of any adverse events one hour after the dose has been administered. Following the recording of any moderate to severe adverse events (determined as ‘Somewhat worse’ [moderate] or ‘Much worse’ [severe] on the participants adverse event record) that has not ameliorated by the time for the next dose, the participant will receive the previous, best tolerated dose. If the effects of the adverse event(s) have disappeared or become milder, and do not interfere with the participant’s daily function or well-being, the caregivers may increase their dose at the indicated rate. Recurrence of adverse events after two attempts to increase the dose will result in the participant remaining at their previous, best tolerated dose for the remainder of the intervention period. If a participant experiences an adverse event they will stay on the previous dose for another two days before the next dose is increased. A registered nurse will administer the medication with morning and afternoon tea (approximately 9am and 2pm). The CongiCann bottles will be delievered to the residential aged care facilities by the pharmacists every Monday. The bottles will be collected after 7 days of use (even if they are half full) and returned to the pharmacy where they can determine how much was used (or left) and then dispose of the bottles to meet Therapeutic Goods Administration (TGA) requirements. At the start of the titration phase, 1 bottle will be administered for each participant (as the lower dose of 2.5mg allows for each bottle to hold 2-3 weeks of the medication). As participants being to reach a higher dose (titration phase, see Table 1 below), 2-3 bottles will be provided on a weekly basis, so each participant will have sufficient medication to last for 7 days. In addition, a process of evaluation will be completed where residential staff and family members will complete pre- (beginning of the first treatment cycle) and post- (end of the second treatment cycle) surveys about their perceptions towards medicinal cannabis oil. At the end of the second treatment cycle, focus groups will be completed with residential care staff and family members.