Cannabinoids as a Treatment for Insomnia in Major Depression
Status:
Not yet recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
This single-site study is a pilot, three-armed, double-blinded, placebo-controlled randomized
controlled trial (RCT) that will determine the feasibility of a definitive RCT investigating
the use of cannabis oil as a treatment for insomnia in individuals with MDD. The study will
also determine whether standard THC with higher CBD vs lower CBD has a differential impact on
insomnia. The study will also analyze other important objective parameters of sleep including
total sleep time and sleep efficiency from actigraphy data. Polysomnography data will also be
analyzed. In addition, standardized, validated instruments will be used to collect data on
severity of depressive symptoms, cognitive functioning biological rhythm disruption, daytime
sleepiness, health-related quality of life (HRQoL), healthcare resource utilization, work
productivity and activity impairment, as well as other side effects, in order to better
understand the potential impact of the use of cannabis oil on these important health
outcomes.