Extended Effects of Cannabis Abstinence on Clinical Symptoms and Cognition in Depression

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Non-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.

Study 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

Primary outcome measure(s)

• Changes in Depressive Symptomology from Baseline to Week 4 — [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. \[Min score = 0, Max score = 52; Higher scores evince more severe symptomology\]
• Changes in Anxious Symptomology from Baseline to Week 4 — [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 \[Min score = 0, Max score = 63; Higher scores evince more severe symptomology\].
• Changes in Sleep Symptomology from Baseline to Week 4 — [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 \[Min score = 0, Max score = 21; Higher scores evince more severe symptomology\].
• Changes in Anhedonia from Baseline to Week 4 — [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 \[Min score = 0, Max score = 14; Higher scores evince more severe symptomology\].

Trial sites (1)

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