Effects of Cannabis Abstinence on Symptomology and Cognition in Bipolar Disorder

September 7, 2023 updated by: Tony George, Centre for Addiction and Mental Health

Effects of Extended Cannabis Abstinence on Clinical and Cognitive Outcomes in Patients With Co-Morbid Bipolar Disorder and Cannabis Use Disorder

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6J1H4
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
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.
Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
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.
Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Investigators

  • Principal Investigator: Tony George, M.D., FRCPC, Centre for Addiction and Mental Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Estimated)

August 31, 2022

Study Completion (Estimated)

August 31, 2022

Study Registration Dates

First Submitted

August 9, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 053/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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