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Effects of Cannabis Abstinence on Symptoms and Cognition in Depression

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ClinicalTrials.gov Identifier: NCT03624933
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Tony George, Centre for Addiction and Mental Health

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.

Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Major Depressive Disorder Cognition Behavioral: Weekly Behavioral Coaching Session Behavioral: Contingency Management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Effects of Extended Cannabis Abstinence on Symptoms and Cognition in Depressed Individuals
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: 28-Day Cannabis Abstinence
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
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.

Behavioral: Contingency Management
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 Measures :
  1. 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). [ Time Frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56) ]
    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 :
  1. 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. [ Time Frame: Bi-Weekly (Day 0, Day 14, Day 28) and at 8 Weeks (Follow-up Day 56) ]
    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.

  2. 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. [ Time Frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56) ]
    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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624933


Contacts
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Contact: Aliya Lucatch, BSc 4165358501 ext 36115 aliya.lucatch@camh.ca
Contact: Julia Sasiadek, BA 4165358501 ext 33095 julia.sasiadek@camh.ca

Locations
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Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M6J1H4
Contact: Tony P George, M.D., FRCPC    4165358501 ext 32662    tony.george@camh.ca   
Principal Investigator: Tony P George, MD, FRCPC         
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Tony George, M.D., FRCPC Centre for Addiction and Mental Health

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Responsible Party: Tony George, Chief, Addictions Division, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT03624933     History of Changes
Other Study ID Numbers: 069/2017
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tony George, Centre for Addiction and Mental Health:
Depression
Cognitive Functioning
Cannabis Use Disorder
Additional relevant MeSH terms:
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Disease
Marijuana Abuse
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders