NCT04935619Recruiting
Extended Effects of Cannabis Abstinence on Clinical Symptoms and Cognition in Depression
Effects of Extended Cannabis Abstinence on Clinical and Cognitive Outcomes in Patients With Co-Morbid Major Depressive and Cannabis Use Disorders
Source: ClinicalTrials.gov · Last updated 24 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 1 Jun 2021
- Start date
- 21 Jul 2021
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Centre for Addiction and Mental Health
- Diseases
- Depression
- NCT number
- NCT04935619
What you commit to
- Study type: Interventional
- Planned participants: 52
- From 21 Jul 2021 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
- Psychotic disorder diagnosis (e.g. schizoaffective disorder, major depression with psychotic features) as determined by the SCID
- Meet SCID for DSM-5 diagnostic criteria for Bipolar Disorder
Other
- Positive urine screen for illicit substances other than cannabis, nicotine, or caffeine
- Current suicidal or homicidal ideation
- Treatment seeking for cannabis use
- Head Injury\> 5 minutes LOC
- Exceed upper and lower cut-offs on HSRD-17 (See Inclusion Criteria)
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Addiction and Mental Health Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.