Extended Effects of Cannabis Abstinence on Clinical Symptoms and Cognition in Depression (NCT04935619) | Clinical Trial Compass
RecruitingNot Applicable
Extended Effects of Cannabis Abstinence on Clinical Symptoms and Cognition in Depression
Canada52 participantsStarted 2021-07-21
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in Depressive Symptomology from Baseline to Week 4
Timeframe: [Time Frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28)]
2
Changes in Anxious Symptomology from Baseline to Week 4
Timeframe: [Time Frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28)]
3
Changes in Sleep Symptomology from Baseline to Week 4
Timeframe: [Time Frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28)]
4
Changes in Anhedonia from Baseline to Week 4
Timeframe: [Time Frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28)]