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Effects of Cannabis Abstinence on Symptomology and Cognition in Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT03629106
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : January 31, 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 Bipolar (Type I or II) disorder. Stabilized bipolar patients (N=52) with CUD will be randomly assigned to one of two groups: 1) A contingent reinforcement (CR) group (n=26); 2) a non-contingent reinforcement (NCR) group (n=26). The study will include a total of 8 visits to the CAMH Russell site (screening, training, baselines, week 1-4, follow-up). Participants should be between the ages of 18-60, meet criteria for CUD (moderate to severe), meet criteria for Bipolar Disorder, be on a stable dose of mood stabilizing medication(s), and be non-treatment seeking cannabis user. The visits will take up a total of approximately 22.5 hours with compensation for time provided for both groups. These visits will involve multiple clinical, substance use, and cognitive assessments. Abstinence will be maintained by weekly behavioural coaching sessions and contingency reinforcement for the CR group.

Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Bipolar Disorder Cognition Behavioral: Weekly Behavioral Coaching Session Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized open-label trial to compare two arms: 1) contingent reinforcement and 2) non-contingent reinforcement.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Extended Cannabis Abstinence on Clinical and Cognitive Outcomes in Patients With Co-Morbid Bipolar Disorder and Cannabis Use Disorder
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Contingent Reinforcement
The Contingent Reinforcement (CR) group (n=26) will be given an abstinence bonus at the successful completion of a 28-Day cannabis abstinence verified by self-report and urinary THC-COOH level <20 ng/ml.
Behavioral: Weekly Behavioral Coaching Session
The participants will be provided with a 20-minute individual behavioral support session weekly for 4 weeks (28 days abstinence), designed to provide them with tools and techniques to manage the craving and withdrawal symptoms that occur with cessation.

Experimental: No Contingent Reinforcement
The Non-Contingent Reinforcement (NCR) group (n=26) will not be given an abstinence bonus at the successful completion of a 28-Day cannabis abstinence.
Behavioral: Weekly Behavioral Coaching Session
The participants will be provided with a 20-minute individual behavioral support session weekly for 4 weeks (28 days abstinence), designed to provide them with tools and techniques to manage the craving and withdrawal symptoms that occur with cessation.




Primary Outcome Measures :
  1. The effects of 28 day cannabis abstinence on change in depressive symptoms in cannabis-dependent patients with bipolar disorder 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.

  2. The effects of 28 day cannabis abstinence on change in hypomania symptoms in cannabis-dependent patients with bipolar disorder as assessed by the Young Mania Rating Scale (YMRS). [ 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.


Secondary Outcome Measures :
  1. The effects of 28 day cannabis abstinence on change in cognitive function in cannabis dependent patients with bipolar disorder 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 motivation and effort (assessed by TOMM) 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 bipolar disorder as assessed by the Beck Anxiety Inventory (BAI). [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All participants must be between the ages 18-60
  • Meet SCID for DSM-5 diagnostic criteria for cannabis use disorder, moderate to severe
  • Meet SCID for DSM-5 diagnostic criteria for Bipolar Disorder (Type I or II)
  • Be an outpatient receiving a stable dose of mood stabilizing medication(s) for at least one month
  • Have a Hamilton Depression Rating Scale (HDRS-17) baseline assessment in the range of 12-25
  • Have a Full-Scale IQ of at least 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 of at least 45
  • Y-MRS baseline score in the range of 0-15

Exclusion Criteria:

  • Meets criteria for abuse or dependence 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
  • Head Injury > 5 minutes LOC
  • Exceed upper and lower cut-offs on HSRD-17 and YMRS

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): NCT03629106


Contacts
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Contact: Alexandria Coles, BA 4165358501 ext 36225 alex.coles@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: NCT03629106     History of Changes
Other Study ID Numbers: 053/2018
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 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:
Bipolar Disorder
Cannabis Use Disorder
Cognitive Function
Additional relevant MeSH terms:
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Disease
Marijuana Abuse
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders