Clinical trial NCT05704582: RCT Comparing Avatar Intervention to Supportive Intervention to Reduce Cannabis Use in Patients With Psychotic Disorders
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
Overall status: RECRUITING
Phase: NA
Conditions: Psychotic Disorders
Cannabis Use Disorder
Mental Health Disorder
Keywords: cannabis
virtual reality intervention
psychotic disorders
substance use disorders
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-01-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-blind randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in cannabis use (Timeline Follow-Back)
timeFrame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Secondary outcomes:
measure: Change in the severity of the cannabis use disorder (Cannabis Use Problems Identification Test - CUPIT)
timeFrame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
measure: Change in quality of life(Quality of Life Enjoyment and Satisfaction Questionnaire - QLESQ-SF & Quality of Life Scale - QLS)
timeFrame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Research center of the Institut universitaire en santé mentale de Montréal
state: Quebec
Study officials:
affiliation: University of Montreal, Institut universitaire en santé mentale de Montréal
name: Alexandre Dumais, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Montreal, Institut universitaire en santé mentale de Montréal
name: Stephane Potvin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: United Arab Emirates University
name: Emmanuel Stip, MD, MSc
role: STUDY_CHAIR
affiliation: University of Montreal, Centre hospitalier de l'Université de Montréal
name: Amal Abdel Baki, MD, MSc
role: STUDY_CHAIR
affiliation: University of Montreal, Institut universitaire en santé mentale de Montréal
name: Robert-Paul Juster, PhD
role: STUDY_CHAIR
affiliation: University of Montreal, Institut universitaire en santé mentale de Montréal
name: Marie-Hélène Goulet, PhD
role: STUDY_CHAIR
affiliation: Institut universitaire en santé mentale de Montréal
name: Luigi De Benedictis, MD
role: STUDY_CHAIR
References: