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

NCT04935619 | Recruiting DMC

• 1 other identifier: 125-2020
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cannabis Use; Major Depressive Disorder; Cognitive Impairment

Keywords

cannabis; substance abuse; depression; anxiety; contingency reinforcement

Outcome Measures

Primary Outcomes (4)

• Changes in Depressive Symptomology from Baseline to Week 4

  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: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28)]

• Changes in Anxious Symptomology from Baseline to Week 4

  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: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28)]

• Changes in Sleep Symptomology from Baseline to Week 4

  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: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28)]

• Changes in Anhedonia from Baseline to Week 4

  The Snaith-Hamilton Pleasure Scale will be administered weekly to measure changes in anhedonia \[Min score = 0, Max score = 14; Higher scores evince more severe symptomology\].

  [Time Frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28)]

Secondary Outcomes (4)

• Changes in Verbal Learning and Memory

  Day 0 and Day 28

• Changes in Attention and Visual Search

  Day 0 and Day 28

• Changes in Working Memory

  Day 0 and Day 28

• Changes in Sustained Attention

  Day 0 and Day 28

Study Arms (2)

Non-Contingency Reinforcement Group

OTHER

Subjects assigned to the NCR group with self-reported abstinence verified by urinary THC-COOH level \<20 ng/ml will not receive contingency monetary reinforcement at Day 28 of the study.

Behavioral: Non-Contingency Reinforcement

Contingency Reinforcement Group

EXPERIMENTAL

Subjects assigned to the CR group with self-reported abstinence verified by urinary THC-COOH level \<20 ng/ml will receive contingency monetary reinforcement at Day 28 of the study.

Behavioral: Contingency Reinforcement

Interventions

Contingency Reinforcement BEHAVIORAL

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.

Contingency Reinforcement Group

Non-Contingency Reinforcement BEHAVIORAL

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 Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Cognitive Dysfunction; Marijuana Abuse; Substance-Related Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Chemically-Induced Disorders; Behavioral Symptoms; Behavior

Study Officials

• Tony P George, MD., FRCPC

  CAMH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryam Sorkhou, HBSc

CONTACT

4165358501; maryam.sorkhou@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 23, 2021
• Study Start: July 21, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)