Appetite stimulation with cannabis-based medicine and methods for assessment of glomerular filtration in older patients with medical illness: a study protocol.

This study is composed of two sub-studies. Sub-study 1 is an investigator-initiated single-center, double-blinded, randomised, placebo-controlled, superiority, cross-over study. Sub-study 1 will recruit 17 older patients with poor appetite, who will also be invited to sub-study 2. Sub-study 2 is a single-dose pharmacokinetics study and will recruit 55 patients. Participants will receive Sativex® and placebo in sub-study 1 and gentamicin with simultaneous measurements of GFR in sub-study 2. The primary endpoints are: sub-study 1) difference in energy intake between Sativex® and placebo conditions, and sub-study 2) accuracy of different eGFR equations compared to mGFR. The secondary endpoints include safety parameters, changes in the appetite hormones, total ghrelin and GLP-1 and subjective appetite sensations and the creation of popPK models of THC, CBD, and gentamicin.