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Effects of Cannabis Abstinence on Symptomology and Cognition in Bipolar Disorder

Primary Purpose

Cannabis Use Disorder, Bipolar Disorder, Cognition

Status

Withdrawn

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Weekly Behavioral Coaching Session

About this trial

This is an interventional treatment trial for Cannabis Use Disorder focused on measuring Bipolar Disorder, Cannabis Use Disorder, Cognitive Function

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Contingent Reinforcement

No Contingent Reinforcement

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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).

The clinical assessment will be administered at Baseline, weekly during the abstinence period and Follow-up and will be conducted by study personnel.

Full Information

NCT ID

NCT03629106

First Posted

August 9, 2018

Last Updated

September 7, 2023

Sponsor

Centre for Addiction and Mental Health

1. Study Identification

Unique Protocol Identification Number

NCT03629106

Brief Title

Effects of Cannabis Abstinence on Symptomology and Cognition in Bipolar Disorder

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of funding

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

August 31, 2022 (Anticipated)

Study Completion Date

August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cannabis Use Disorder, Bipolar Disorder, Cognition

Keywords

Bipolar Disorder, Cannabis Use Disorder, Cognitive Function

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Contingent Reinforcement

Arm Type

Experimental

Arm Description

Arm Title

No Contingent Reinforcement

Arm Type

Experimental

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

Weekly Behavioral Coaching Session

Intervention Description

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 Measure Information:

Title

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).

Description

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

Time Frame

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

Title

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).

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Description

Time Frame

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

Title

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).

Description

The clinical assessment will be administered at Baseline, weekly during the abstinence period and Follow-up and will be conducted by study personnel.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tony George, M.D., FRCPC

Organizational Affiliation

Centre for Addiction and Mental Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre for Addiction and Mental Health

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6J1H4

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Effects of Cannabis Abstinence on Symptomology and Cognition in Bipolar Disorder

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