Extended Effects of Cannabis Abstinence on Clinical Symptoms and Cognition in Depression
Recruiting · NCT04935619 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre for Addiction and Mental Health
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The prevalence of major depressive disorder (MDD) is \~5.0%, and rates of co-occurring SUDs in these patients approach 40-50%. Specifically, rates of co-morbid cannabis use disorder (CUD) in patients with MDD are elevated 2-3 fold compared to 2.9% in the general population, and is associated with poorer treatment outcomes and impaired cognitive and psychosocial functioning in comparison to MDD patients without CUD. Most studies of cannabis use in MDD are cross-sectional in design, and therefore causal relationships are unclear. This study investigates the effects of cannabis abstinence over a 28-day period in patients with MDD with co-occurring CUD using a randomized controlled design, namely contingent reinforcement.
Who can take part
Inclusion criteria
- All participants must be between the ages 18-55
- Meet SCID for DSM-5 diagnostic criteria for cannabis use disorder, moderate to severe
- Meet SCID for DSM-5 diagnostic criteria for Major Depressive Disorder
- Be an outpatient receiving a stable dose of antidepressant medication for at least three months (to ensure stability of depressive symptoms
- Have a Hamilton Depression Rating Scale (HDRS-17) at baseline assessment in the range of 12-25..
- Have a Full-Scale IQ ≥ 80 as determined by the WTAR
- Be a non-treatment seeking cannabis user
- Evidence of sufficient motivation and effort as measured by a Test of Memory Malingering (TOMM) score ≥ 45.
Exclusion criteria
- Meets criteria for substance use disorder of alcohol or other illicit substances within the past 6 months (with the exception of cannabis, nicotine, or caffeine)
- Positive urine screen for illicit substances other than cannabis, nicotine, or caffeine
- Current suicidal or homicidal ideation
- Psychotic disorder diagnosis (e.g. schizoaffective disorder, major depression with psychotic features) as determined by the SCID
- Treatment seeking for cannabis use
- Meet SCID for DSM-5 diagnostic criteria for Bipolar Disorder
- Head Injury\> 5 minutes LOC
- Exceed upper and lower cut-offs on HSRD-17 (See Inclusion Criteria)
Where it is running
1 location listed.
- Centre for Addiction and Mental Health - Toronto, Ontario, Canada