Effects of Cannabis Abstinence on Symptomology and Cognition in Bipolar Disorder

Center for Addiction and Mental Health (CAMH)

Status: Withdrawn

Conditions: Cannabis Use Disorder; Bipolar Disorder; Cognition

Treatments: Behavioral: Weekly Behavioral Coaching Session

Study type: Interventional

Funder types: Other

Identifiers

NCT03629106

053/2018

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Contingent Reinforcement

Experimental group

Description:

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.

Treatment:

Behavioral: Weekly Behavioral Coaching Session

No Contingent Reinforcement

Experimental group

Description:

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.

Treatment:

Behavioral: Weekly Behavioral Coaching Session