NCT04935619 Extended Effects of Cannabis Abstinence on Clinical Symptoms and Cognition in Depression
| NCT ID | NCT04935619 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre for Addiction and Mental Health |
| Condition | Cannabis Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2021-07-21 |
| Primary Completion | 2027-06-30 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
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 * Psych