Contingency Reinforcement
Subjects will be randomly assigned on a 1:1 ratio to either the Contingency Reinforcement or Non-Contingency Reinforcement Intervention prior to their in-person screening visit.
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2025-02-24
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
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. To date, most studies of cannabis use in MDD were cross-sectional in design, and therefore causal relationships are unclear. The investigators previous studies in cannabis dependent patients with schizophrenia suggest that extended cannabis abstinence (up to 28 days) using contingent reinforcement is associated with improvements in specific areas of cognition (e.g. verbal learning and memory) and depressive symptoms. A more recent study using an open-label design demonstrated that 28 days of cannabis abstinence improves depressive symptoms and anhedonia in participants (N=11) with co-occurring MDD and CUD. The investigators propose a controlled cannabis abstinence paradigm in patients with co-morbid MDD and CUD (N=52) to further investigate these findings. Stabilized MDD patients with moderate to severe CUD will be randomly assigned to one of two groups: 1) A contingent reinforcement (CR) intervention (n=26); 2) a non-contingent reinforcement (NCR) intervention (n=26), which will serve as a time and non-abstinence control. In the CR group, subjects achieving biochemically-verified cannabis abstinence at study endpoint (Day 28) will receive a $300 contingent payment; participants in the NCR group will not receive this contingent payment. The primary outcomes are: 1) cannabis abstinence rates at Day 28 in CR versus NCR groups; 2) changes in mood (depressive), anxiety and sleep symptoms over the 28-day assessment period. Secondary outcomes include cognition.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Subjects will be randomly assigned on a 1:1 ratio to either the Contingency Reinforcement or Non-Contingency Reinforcement Intervention prior to their in-person screening visit.
Subjects will be randomly assigned on a 1:1 ratio to either the Contingency Reinforcement or Non-Contingency Reinforcement Intervention prior to their in-person screening visit.
Eligibility
primary outcomes
Time frame: [Time Frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28)]
The Hamilton Depression Rating Scale will be administered to assess severity of depressive symptoms. \[Min score = 0, Max score = 52; Higher scores evince more severe symptomology\]
Time frame: [Time Frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28)]
The Beck Anxiety Inventory will be administered to assess severity of anxiety symptoms \[Min score = 0, Max score = 63; Higher scores evince more severe symptomology\].
Time frame: [Time Frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28)]
The Pittsburgh Sleep Quality Index will be administered weekly to examine quality of sleep and other sleep disturbances \[Min score = 0, Max score = 21; Higher scores evince more severe symptomology\].
Time frame: [Time Frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28)]
The Snaith-Hamilton Pleasure Scale will be administered weekly to measure changes in anhedonia \[Min score = 0, Max score = 14; Higher scores evince more severe symptomology\].
secondary outcomes
Time frame: Day 0 and Day 28
The Hopkins Verbal Learning Test will be administered to investigate this cognitive domain.
Time frame: Day 0 and Day 28
The Trail Making Test will be administered to investigate these cognitive domains
Time frame: Day 0 and Day 28
The Digit Span test will be administered to investigate this cognitive domain.
Time frame: Day 0 and Day 28
The Continuous Performance Test will be administered to investigate this cognitive domain
Publications
No exact PMID-linked public article is currently readable locally.