CompletedPhase 2

Cannabinoids as a Treatment for Insomnia in Major Depression

Canada14 participantsStarted 2023-08-28

Plain-language 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. Optional polysomnography data may also be collected and 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.

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. Age 19 or above (A minimal age of 19 was chosen in order to align with the cannabis legalization rules of the Province of Ontario, where the research participants will be recruited from: https://www.ontario.ca/page/cannabis-legalization#section-1)
✓. Diagnosis of MDD according to the Structured Clinical Interview for DSM-5 (SCID-5)
✓. Diagnosis of Insomnia Disorder according to the Duke Structured Interview for Sleep Disorders Patient Health Questionnaire (PHQ-9) score of \<10, indicating severity of mild-to-no depression (This criterion is important because a proper diagnosis of current co-morbid insomnia disorder cannot be accurately ascertained during acute major depressive episodes)
✓. Participant must be willing and able to complete self-reported assessments, including having sufficient fluency in English
✓. Participant must be willing to wear a wrist-worn actiwatch device
✓. Participants may be using psychotropic medications for treatment of depression, except benzodiazepines or any other sleep aids, as long as the dosage remains the same from a minimum of 2 months prior to study enrolment until the end of the study (This criterion is important because many individuals with MDD use antidepressant agents and this criterion would make the results more generalizable and useful in real life clinical practice)

Exclusion criteria

What they're measuring

Recruitment Rate

Timeframe: 1 year, at the completion of the study

Retention Rate

Timeframe: 1 year, at the completion of the study

Trial details

NCT IDNCT05041647

SponsorSt. Joseph's Healthcare Hamilton

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-31

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