Effects of Cannabis Abstinence on Symptomology and Cognition in Bipolar Disorder
NCT ID: NCT03629106
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-10-01
2022-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Centre for Addiction and Mental Health
OTHER
Responsible Party
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Tony George
Chief, Addictions Division
Principal Investigators
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Tony George, M.D., FRCPC
Role: PRINCIPAL_INVESTIGATOR
Centre for Addiction and Mental Health
Locations
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Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
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Other Identifiers
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053/2018
Identifier Type: -
Identifier Source: org_study_id
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