An interventional study of Weekly Behavioral Coaching Session and Contingency Management in Cannabis Use Disorder, Major Depressive Disorder and Cognition, sponsored by Centre for Addiction and Mental Health. Completed at 1 site in Canada. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-09-05.
Sponsored by Centre for Addiction and Mental Health · Not applicable, Interventional, and Treatment
The objective of this study is to assess the changes in symptoms and cognition that occur after a 28-day abstinence period in patients with comorbid Cannabis Use Disorder (CUD) and Major Depression (MDD). This study employs a 28-day abstinence paradigm a total of 8 visits to the CAMH Russell site (screening, training, baseline, week 1, week 2, week 3, week 4, follow-up). Participants should be between the ages of 18-55, meet criteria for moderate depression and CUD, be non-treatment seeking, and be on a stable dose of antidepressant medication. The study visits will take up a total of approximately 22.5 hours with compensation for time provided. These visits will involve multiple clinical, substance use, and cognitive assessments. Abstinence will be maintained by weekly behavioural coaching sessions and contingency reinforcement.
2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.
This study's enrollment of 19 is below the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.
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The study will assess the changes that occur after a 28-day abstinence period in patients with Major Depressive Disorder (MDD) and comorbid Cannabis Use Disorder (CUD). Patients will be instructed to initiate abstinence 12 hours prior to the baseline session and will come in for weekly visits involving a series of clinical, cognitive, and substance use assessments.
Behavioral: Weekly Behavioral Coaching Session · Behavioral: Contingency Management
The participants will be provided with a 20-minute individual behavioral support session weekly for 4 weeks (28 days of abstinence), designed to provide them with tools and techniques to manage the craving and withdrawal symptoms that occur with cessation.
If the participant's weekly abstinence is successful as determined by the urine results on day 28, the participant will receive an additional $300.00 cash bonus on top of their hourly $10 compensation for attending all visits. We predict that this cash bonus is enough incentive to allow for the behavioural change of abstinence in this patient population.
The effects of 28 day cannabis abstinence on change in depressive symptoms in cannabis-dependent patients with Major Depressive Disorder (MDD) as assessed by the Hamilton Rating Scale for Depression (HRSD).
The clinical assessment will be administered weekly during the abstinence period and conducted by study personnel. The HRDS is used to evaluate depression on a 17-item scale with higher values indicating worse depressive symptoms.
Time frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)
The effects of 28 day cannabis abstinence on change in cognitive function in cannabis dependent patients with Major Depressive Disorder (MDD) as assessed by a cognitive battery administered at Baseline, Week 2, Endpoint and Follow-Up.
The cognitive battery will include the primary outcome of verbal memory (assessed by Hopkins Verbal Learning Test) and will be compared to baseline (Day 1) performance. Cortical inhibition will also be assessed and compared.
Time frame: Bi-Weekly (Day 0, Day 14, Day 28) and at 8 Weeks (Follow-up Day 56)
The effects of 28 day cannabis abstinence on change in co-occurring anxiety in cannabis dependent patients with MDD as assessed by the Beck Anxiety Inventory (BAI) administered weekly.
The clinical assessment will be administered at Baseline, weekly during the abstinence period and Follow-up and will be conducted by study personnel. The BAI is a 21-item scale used to evaluate the severity of anxiety symptoms with higher values indicating worse outcomes.
Time frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)
Ran from Nov 2017 to primary completion in Dec 2019, 25 months.
Of 612 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 25 months is below that.
Counting every sponsor, half of 652 studies reached it within 30 months; a quarter within 16 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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