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

A Randomized Controlled Trial Comparing Avatar Intervention to an Addiction Supportive Intervention to Reduce Cannabis Use in Patients With Psychotic Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Psychotic Disorders; Mental Health Disorder; Cannabis Use Disorder
• Intervention / Treatment: Other: Avatar Intervention; Other: Addiction supportive intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandre Dumais, MD, PhD; Phone Number: 3212 514-251-4000; Email: contact@avatar-intervention.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1N 3M5
      • Recruiting
      • Research center of the Institut universitaire en santé mentale de Montréal
      • Principal Investigator: Alexandre Dumais, MD, PhD
      • Principal Investigator: Stéphane Potvin, PhD
      • Contact: Alexandre Dumais, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Avatar Intervention; 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.	Other: Avatar Intervention; 8 weekly sessions of 60 minutes. Possibility of 4 additional sessions.; Other Names: Avatar-CUD
Active Comparator: Addiction supportive intervention; 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.	Other: Addiction supportive intervention; 8 weekly sessions of 60 minutes. Possibility of 4 additional sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
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	Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months

Collaborators and Investigators

• Sponsor: Ciusss de L'Est de l'Île de Montréal
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Study Chair: Emmanuel Stip, MD, MSc, United Arab Emirates University; Study Chair: Amal Abdel Baki, MD, MSc, University of Montreal, Centre hospitalier de l'Université de Montréal; Study Chair: Robert-Paul Juster, PhD, University of Montreal, Institut universitaire en santé mentale de Montréal; Study Chair: Marie-Hélène Goulet, PhD, University of Montreal, Institut universitaire en santé mentale de Montréal; Study Chair: Luigi De Benedictis, MD, Institut Universitaire en Santé Mentale de Montréal; Principal Investigator: Alexandre Dumais, MD, PhD, University of Montreal, Institut universitaire en santé mentale de Montréal; Principal Investigator: Stéphane Potvin, PhD, University of Montreal, Institut universitaire en santé mentale de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: cannabis; substance use disorders; psychotic disorders; virtual reality intervention
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Substance-Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders; Marijuana Abuse
• Other Study ID Numbers: MP-12-2023-3234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No