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

NCT ID: NCT05704582

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2028-01-31

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.

Conditions

Psychotic Disorders; Cannabis Use Disorder; Mental Health Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Avatar Intervention

Intervention Type: OTHER

8 weekly sessions of 60 minutes. Possibility of 4 additional sessions.

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.

Group Type: ACTIVE_COMPARATOR

Addiction supportive intervention

Intervention Type: OTHER

8 weekly sessions of 60 minutes. Possibility of 4 additional sessions.

Interventions

Avatar Intervention

8 weekly sessions of 60 minutes. Possibility of 4 additional sessions.

Intervention Type: OTHER

Addiction supportive intervention

8 weekly sessions of 60 minutes. Possibility of 4 additional sessions.

Intervention Type: OTHER

Other Intervention Names

Avatar-CUD

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Ciusss de L'Est de l'Île de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandre Dumais, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Montreal, Institut universitaire en santé mentale de Montréal

Stephane Potvin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Montreal, Institut universitaire en santé mentale de Montréal

Emmanuel Stip, MD, MSc

Role: STUDY_CHAIR

United Arab Emirates University

Amal Abdel Baki, MD, MSc

Role: STUDY_CHAIR

University of Montreal, Centre hospitalier de l'Université de Montréal

Robert-Paul Juster, PhD

Role: STUDY_CHAIR

University of Montreal, Institut universitaire en santé mentale de Montréal

Marie-Hélène Goulet, PhD

Role: STUDY_CHAIR

University of Montreal, Institut universitaire en santé mentale de Montréal

Luigi De Benedictis, MD

Role: STUDY_CHAIR

Institut universitaire en santé mentale de Montréal

Locations

Research center of the Institut universitaire en santé mentale de Montréal

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Alexandre Dumais, MD, PhD

Role: CONTACT

contact@avatar-intervention.ca

514-251-4000 ext. 3212

Facility Contacts

Alexandre Dumais, MD, PhD

Role: primary

Other Identifiers

MP-12-2023-3234

Identifier Type: -

Identifier Source: org_study_id