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RCT Comparing Avatar Intervention to Supportive Intervention to Reduce Cannabis Use in Patients With Psychotic Disorders (AC2)

Primary Purpose

Psychotic Disorders, Cannabis Use Disorder, Mental Health Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Avatar Intervention
Addiction supportive intervention
Sponsored by
Ciusss de L'Est de l'Île de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring cannabis, virtual reality intervention, psychotic disorders, substance use disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males or females over 18 years of age who meet the DSM-5 criteria for CUD (≥4 criteria) ; Patients will meet the DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder with psychotic symptoms. Diagnoses will be established with the Structured Interview for DSM-5 (SCID-5). Exclusion Criteria: Current SUD for a substance other than cannabis ; Ongoing pharmacological or psychological treatment for CUD ; Ongoing detoxification for cannabis withdrawal ; Presence of neurological disorders ; Presence of a severe and unstable physical illness ; Inability to provide consent.

Sites / Locations

  • Research center of the Institut universitaire en santé mentale de MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Avatar Intervention

Addiction supportive intervention

Arm Description

The Avatar Intervention will take place over 8 consecutive weeks, with one session per week. Additional sessions (up to a maximum of 4 sessions) will be offered if needed. Each session will last approximately 60 minutes. The goal of the intervention will be to help you reduce cravings related to your cannabis use with the use of virtual reality and avatars.

The Addiction supportive intervention will take place over 8 consecutive weeks, with one session per week. Additional sessions (up to a maximum of 4 sessions) will be offered if needed. Each session will last approximately 60 minutes. The goal of the intervention will be to help you reduce cravings related to your cannabis use.

Outcomes

Primary Outcome Measures

Change in cannabis use (Timeline Follow-Back)
A standardized tool consisting of asking the patients how many joints they smoked each day of the week during the past week.

Secondary Outcome Measures

Change in the severity of the cannabis use disorder (Cannabis Use Problems Identification Test - CUPIT)
16-item self-reported questionnaire assessing cannabis use and dependence; Range 3-82, higher values indicating a more severe cannabis use disorder
Change in quality of life(Quality of Life Enjoyment and Satisfaction Questionnaire - QLESQ-SF & Quality of Life Scale - QLS)
QLESQ-SF: 16-item self-reported scale measuring enjoyment and satisfaction experienced during the past week in various areas of daily functioning; Range 14-70, Higher values indicate a better satisfaction of life QLS: 21-item scale based on a semistructured interview designed to assess deficit symptoms; Range 0-126, higher values indicate a better quality of life

Full Information

First Posted
January 20, 2023
Last Updated
February 24, 2023
Sponsor
Ciusss de L'Est de l'Île de Montréal
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT05704582
Brief Title
RCT Comparing Avatar Intervention to Supportive Intervention to Reduce Cannabis Use in Patients With Psychotic Disorders
Acronym
AC2
Official Title
A Randomized Controlled Trial Comparing Avatar Intervention to an Addiction Supportive Intervention to Reduce Cannabis Use in Patients With Psychotic Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
January 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ciusss de L'Est de l'Île de Montréal
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to conduct a single-blind randomized controlled trial to verify whether the Avatar Intervention has greater efficacy over supportive intervention to reduce cannabis use in patients with psychotic disorders.
Detailed Description
Psychotic disorders (PD) are characterized by a loss of contact with reality. Cannabis use is one of the key factors leading to psychiatric re-hospitalization in PD. In these populations, cannabis use is also associated with depressive symptoms, medication non-compliance, hostility as well as reduced quality of life. Unfortunately, there is no evidence-based intervention available for the treatment of cannabis use disorder (CUD) in this population. Novel interventions for CUD are thus critically needed. Virtual reality-based therapies are a promising avenue that allow patients to try novel strategies in real time instead of having to learn abstract rules. To fill a clinical need, the investigators have created a distinctive intervention for CUD in patients with PD. The Avatar Intervention displays strong experiential and relational components that are crucially missing in conventional interventions. Hence, the primary outcomes are reductions in cannabis use, cannabis use disorder severity, and increased quality of life. The investigators will also explore whether the greater improvements attributable to the Avatar Intervention persist in time, and perform analyses on sex/gender, motivation to change cannabis habits, psychotic relapses, and THC metabolite levels. Noteworthily, cannabis-related hospitalizations have been identified as one of the core indicators to measure the success of cannabis legalization. As a result, there is a pressing need to design innovative interventions that could have a significant impact on this costly and prime outcome. As there is no evidence-based therapeutic options for CUD in patients with PD, the current trial will contribute to the validation of a novel approach and create new therapeutic possibilities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Cannabis Use Disorder, Mental Health Disorder
Keywords
cannabis, virtual reality intervention, psychotic disorders, substance use disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single-blind randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Avatar Intervention
Arm Type
Experimental
Arm Description
The Avatar Intervention will take place over 8 consecutive weeks, with one session per week. Additional sessions (up to a maximum of 4 sessions) will be offered if needed. Each session will last approximately 60 minutes. The goal of the intervention will be to help you reduce cravings related to your cannabis use with the use of virtual reality and avatars.
Arm Title
Addiction supportive intervention
Arm Type
Active Comparator
Arm Description
The Addiction supportive intervention will take place over 8 consecutive weeks, with one session per week. Additional sessions (up to a maximum of 4 sessions) will be offered if needed. Each session will last approximately 60 minutes. The goal of the intervention will be to help you reduce cravings related to your cannabis use.
Intervention Type
Other
Intervention Name(s)
Avatar Intervention
Other Intervention Name(s)
Avatar-CUD
Intervention Description
8 weekly sessions of 60 minutes. Possibility of 4 additional sessions.
Intervention Type
Other
Intervention Name(s)
Addiction supportive intervention
Intervention Description
8 weekly sessions of 60 minutes. Possibility of 4 additional sessions.
Primary Outcome Measure Information:
Title
Change in cannabis use (Timeline Follow-Back)
Description
A standardized tool consisting of asking the patients how many joints they smoked each day of the week during the past week.
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Secondary Outcome Measure Information:
Title
Change in the severity of the cannabis use disorder (Cannabis Use Problems Identification Test - CUPIT)
Description
16-item self-reported questionnaire assessing cannabis use and dependence; Range 3-82, higher values indicating a more severe cannabis use disorder
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Title
Change in quality of life(Quality of Life Enjoyment and Satisfaction Questionnaire - QLESQ-SF & Quality of Life Scale - QLS)
Description
QLESQ-SF: 16-item self-reported scale measuring enjoyment and satisfaction experienced during the past week in various areas of daily functioning; Range 14-70, Higher values indicate a better satisfaction of life QLS: 21-item scale based on a semistructured interview designed to assess deficit symptoms; Range 0-126, higher values indicate a better quality of life
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females over 18 years of age who meet the DSM-5 criteria for CUD (≥4 criteria) ; Patients will meet the DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder with psychotic symptoms. Diagnoses will be established with the Structured Interview for DSM-5 (SCID-5). Exclusion Criteria: Current SUD for a substance other than cannabis ; Ongoing pharmacological or psychological treatment for CUD ; Ongoing detoxification for cannabis withdrawal ; Presence of neurological disorders ; Presence of a severe and unstable physical illness ; Inability to provide consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Dumais, MD, PhD
Phone
514-251-4000
Ext
3212
Email
contact@avatar-intervention.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Dumais, MD, PhD
Organizational Affiliation
University of Montreal, Institut universitaire en santé mentale de Montréal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephane Potvin, PhD
Organizational Affiliation
University of Montreal, Institut universitaire en santé mentale de Montréal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emmanuel Stip, MD, MSc
Organizational Affiliation
United Arab Emirates University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amal Abdel Baki, MD, MSc
Organizational Affiliation
University of Montreal, Centre hospitalier de l'Université de Montréal
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Robert-Paul Juster, PhD
Organizational Affiliation
University of Montreal, Institut universitaire en santé mentale de Montréal
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marie-Hélène Goulet, PhD
Organizational Affiliation
University of Montreal, Institut universitaire en santé mentale de Montréal
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luigi De Benedictis, MD
Organizational Affiliation
Institut universitaire en santé mentale de Montréal
Official's Role
Study Chair
Facility Information:
Facility Name
Research center of the Institut universitaire en santé mentale de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Dumais, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alexandre Dumais, MD, PhD
First Name & Middle Initial & Last Name & Degree
Stephane Potvin, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

RCT Comparing Avatar Intervention to Supportive Intervention to Reduce Cannabis Use in Patients With Psychotic Disorders

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