Effects of Cannabis Abstinence on Symptomology and Cognition in Bipolar Disorder

NCT03629106 | Withdrawn DMC

• 1 other identifier: 053/2018
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use Disorder; Bipolar Disorder; Cognition

Keywords

Bipolar Disorder; Cannabis Use Disorder; Cognitive Function

Outcome Measures

Primary Outcomes (2)

• 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).

  The clinical assessment will be administered weekly during the abstinence period and conducted by study personnel.

  Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)

• 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).

  The clinical assessment will be administered weekly during the abstinence period and conducted by study personnel.

  Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)

Secondary Outcomes (2)

• 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.

  Bi-Weekly (Day 0, Day 14, Day 28) and at 8 Weeks (Follow-up Day 56)

• 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).

  Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)

Study Arms (2)

Contingent Reinforcement

EXPERIMENTAL

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

No Contingent Reinforcement

EXPERIMENTAL

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

Interventions

Weekly Behavioral Coaching Session BEHAVIORAL

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.

Contingent Reinforcement; No Contingent Reinforcement

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1H4, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Tony George, M.D., FRCPC

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Addictions Division

Model Details: Randomized open-label trial to compare two arms: 1) contingent reinforcement and 2) non-contingent reinforcement.

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 14, 2018
• Study Start: October 1, 2018
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

CA (1)