Back to resultsEffects of Cannabis Abstinence on Symptoms and Cognition in Depression
Primary Purpose
Cannabis Use Disorder, Major Depressive Disorder, Cognition
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Weekly Behavioral Coaching Session
Contingency Management
Sponsored by
About this trial
This is an interventional treatment trial for Cannabis Use Disorder focused on measuring Depression, Cognitive Functioning, Cannabis Use Disorder
Eligibility Criteria
Inclusion Criteria:
- ages 18-55
- meet DSM-5 diagnostic criteria for cannabis use disorder (cannabis use >1 g/day, CUDIT score >12)
- meet DSM-5 diagnostic criteria for Major Depressive Disorder as determined using the SCID
- be an outpatient receiving a stable dose of antidepressant medication(s) for at least 1 month
- have a Hamilton Depression Rating Scale (HDRS-17) baseline total score greater than 14
- have a Full Scale IQ greater than 80 as determined by the WTAR
- be a non-treatment seeking cannabis user
- evidence of sufficient motivation and effort as measure by a Test of Memory Malingering (TOMM) score greater than 45
- urinary baseline THC-COOH levels greater than 150 ng/ml
Exclusion Criteria:
- meets criteria for abuse or dependence of alcohol or other illicit substances within the part 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
- head injury with loss of consciousness greater than 2 minutes or requiring hospitalization
- neurological or medical condition determined to effect cognition
- be treatment seeking for cannabis use
Sites / Locations
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
28-Day Cannabis Abstinence
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03624933
First Posted
July 25, 2018
Last Updated
September 1, 2023
Sponsor
Centre for Addiction and Mental Health
1. Study Identification
Unique Protocol Identification Number
NCT03624933
Brief Title
Effects of Cannabis Abstinence on Symptoms and Cognition in Depression
Official Title
Effects of Extended Cannabis Abstinence on Symptoms and Cognition in Depressed Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder, Major Depressive Disorder, Cognition
Keywords
Depression, Cognitive Functioning, Cannabis Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is an open label intervention of contingent reinforcement and behavioral support to try to enhance cannabis abstinence for 28 days with people with Major Depressive Disorder. We will analyze data post hoc from this study as a function of subjects who attain abstinence versus those who do not.
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
28-Day Cannabis Abstinence
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Weekly Behavioral Coaching Session
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Description
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)
Secondary Outcome Measure Information:
Title
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.
Description
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)
Title
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.
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ages 18-55
meet DSM-5 diagnostic criteria for cannabis use disorder (cannabis use >1 g/day, CUDIT score >12)
meet DSM-5 diagnostic criteria for Major Depressive Disorder as determined using the SCID
be an outpatient receiving a stable dose of antidepressant medication(s) for at least 1 month
have a Hamilton Depression Rating Scale (HDRS-17) baseline total score greater than 14
have a Full Scale IQ greater than 80 as determined by the WTAR
be a non-treatment seeking cannabis user
evidence of sufficient motivation and effort as measure by a Test of Memory Malingering (TOMM) score greater than 45
urinary baseline THC-COOH levels greater than 150 ng/ml
Exclusion Criteria:
meets criteria for abuse or dependence of alcohol or other illicit substances within the part 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
head injury with loss of consciousness greater than 2 minutes or requiring hospitalization
neurological or medical condition determined to effect cognition
be treatment seeking for cannabis use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony George, M.D., FRCPC
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J1H4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
35690891
Citation
Sorkhou M, Rabin RA, Rabin JS, Kloiber S, McIntyre RS, George TP. Effects of 28 days of cannabis abstinence on cognition in major depressive disorder: A pilot study. Am J Addict. 2022 Sep;31(5):454-462. doi: 10.1111/ajad.13305. Epub 2022 Jun 11.
Results Reference
derived
Learn more about this trial
Effects of Cannabis Abstinence on Symptoms and Cognition in Depression
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