Overview

Cannabinoids as a Treatment for Insomnia in Major Depression

Status:
Not yet recruiting
Trial end date:
2022-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
St. Joseph's Healthcare Hamilton
Collaborator:
McMaster University
Treatments:
Dronabinol
Criteria
Inclusion Criteria

1. 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)

2. Diagnosis of MDD according to the Structured Clinical Interview for DSM-5 (SCID-5) 37

3. Diagnosis of Insomnia Disorder according to the Duke Structured Interview for Sleep
Disorders 38 Patient Health Questionnaire (PHQ-9) 39 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)

4. Participant must be willing and able to complete self-reported assessments, including
having sufficient fluency in English

5. Participant must be willing to wear a wrist-worn actiwatch device

6. 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

1. Lifetime diagnosis of Schizophrenia, Bipolar Disorder or any other psychotic disorder,
as well as current or recent (last 6 months) Alcohol or Substance Use Disorder
according to the SCID-5

2. Individuals with current diagnosis of Generalized Anxiety Disorder, Panic Disorder,
Obsessive-Compulsive Disorder, Post-Traumatic Stress Disorder or Eating Disorder will
be excluded because these psychiatric disorders are associated with sleep disturbance;
however, because of the high rates of co-morbid psychiatric conditions in MDD
lifetime/past diagnosis will be allowed in order for the results to be generalizable
and useful in real life clinical practice

3. Current use of benzodiazepines or any other sleep aids

4. Positive screening for drugs of abuse including but not limited to opioids, cannabis,
benzodiazepines, cocaine, and/or amphetamines (except prescribed stimulants for
comorbid ADHD)

5. Presence of any sleep disorder other than insomnia that is considered the primary
diagnosis, determined by the Duke Structured Interview for Sleep Disorders (e.g. Sleep
Apnea, Limb Movement Disorder, or Circadian Rhythm Disorders)

6. Presence of unstable medical conditions

7. Pregnancy or breastfeeding (female participants will need to agree to use an
acceptable contraceptive method during the study because of potential unknown
teratogenic effects of cannabinoids

8. Allergy to cannabis or any components of the cannabis treatment (including terpenes)