Cannabis Use Disorder, Mental Health Disorder, Psychotic Disorders
Conditions
Keywords
cannabis, virtual reality intervention, psychotic disorders, substance use disorders
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.
Interventions
OTHERAvatar Intervention
8 weekly sessions of 60 minutes. Possibility of 4 additional sessions.
OTHERAddiction supportive intervention
8 weekly sessions of 60 minutes. Possibility of 4 additional sessions.
Sponsors
Canadian Institutes of Health Research (CIHR)
Ciusss de L'Est de l'Île de Montréal
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Single-blind randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cannabis use (Timeline Follow-Back) | Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months | A standardized tool consisting of asking the patients how many joints they smoked each day of the week during the past week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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, follow-ups at 3 months, 6 months and 12 months | 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) | Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months | 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 |
Countries
Canada
Contacts
Primary ContactAlexandre Dumais, MD, PhD
Outcome results
None listed