A study exploring the ease with which placebo Suboxone sublingual films can be removed from the mouth after specified times, when administered stacked on top of each other compared to spaced out around the mouth.

This study will adopt a repeated measures crossover design with two conditions: film stacking and film spacing. The ease with which the film can be removed from the mouth, following dosing, will be examined. Participants will be provided with placebo film (equivalent in number to their usual dose denomination) and will be asked to try to remove the film following its administration. This will be repeated at various time points: 15 seconds, 30 seconds and 1 minute following administration. Hence, each subject will undergo six different dosing conditions (except for the patients on 1 Suboxone Film where stacking cannot occur, with only 3 conditions). Patients will be asked to estimate the proportion of the film removed on each occasion (none, partial, whole). All sessions will be conducted in a random order design, with 6 subjects required for those receiving one Film, and 12 subjects for each number of multiple films being administered (2,3 or 4), for a total of 42 subjects. For the stacking conditions, participants will be instructed to administer the film by stacking (i.e. with more than 1 film, the participants will be asked to make the multiple films overlap). For the spaced (side by side) conditions, participants will be instructed to follow specific placement of the films in their mouth (i.e. maximum of 2 films to be placed side-by-side under the tongue and other films buccally on each cheek). Participants will be required to wait 15 minutes between each testing application and have a drink (30ml) of water immediately prior to administering film on each occasion. Hence each session should take approximately 3 hours per participant.