Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Severe Mental Health Disorders

NCT05726617 | Active Not Recruiting DMC

• 1 other identifier: MP-12-2019-1564
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a proof-of-concept of a new Virtual Reality (VR) Avatar Intervention for Cannabis Use Disorders (CUD) in patients with psychotic disorders and/or mood disorders. The primary outcomes are reductions in cannabis use, cannabis use disorder severity, and increased quality of life.

Conditions

Psychotic Disorders; Cannabis Use Disorder; Mental Health Disorder

Keywords

cannabis; virtual reality intervention; psychotic disorders; substance use disorders

Outcome Measures

Primary Outcomes (1)

• 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 as well as 3- 6- and 12-months follow-up

Secondary Outcomes (4)

• Change in the severity of the cannabis use disorder (Cannabis Use Problems Identification Test - CUPIT)

  Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up

• Change in quality of life (Quality of Life Scale -QLS)

  Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up

• Motivation to change cannabis use (Marijuana Ladder)

  Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up

• Change in psychiatric symptoms (Positive And Negative Syndrome Scale - PANSS)

  Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up

Study Arms (1)

Experimental: Avatar Intervention

EXPERIMENTAL

The Avatar Intervention will take place over 8 consecutive weeks, with one session per week. 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.

Behavioral: Avatar Intervention

Interventions

Avatar Intervention BEHAVIORAL

8 weekly sessions of 60 minutes.

Also known as: Avatar-CUD

Experimental: Avatar Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, bipolar disorder and major depression. Diagnoses will be established with the Structured Interview for DSM-5 (SCID-5).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

Research center of the Institut universitaire en santé mentale de Montréal

Montreal, Quebec, H1N 3M5, Canada

Location

MeSH Terms

Conditions

Psychotic Disorders; Mental Disorders; Marijuana Abuse; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Chemically-Induced Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Robert-Paul Juster

  University of Montreal, Institut universitaire en santé mentale de Montréal

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pilot clinical trial, single arm

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 14, 2023
• Study Start: September 24, 2019
• Primary Completion: August 11, 2022
• Study Completion: December 31, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)