Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05704582

RCT Comparing Avatar Intervention to 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research center of the Institut universitaire en santé mentale de Montréal

Montreal, Quebec, H1N 3M5, Canada

Location status: Recruiting

Location contact

Alexandre Dumais, MD, PhD

CONTACT

Alexandre Dumais, MD, PhD

PRINCIPAL_INVESTIGATOR

Stephane Potvin, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Avatar Intervention

Other

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

Other names: Avatar-CUD

Addiction supportive intervention

Other

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

Primary outcomes

  1. Change in cannabis use (Timeline Follow-Back)

    Time frame: 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 outcomes

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

    Time frame: 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

  2. Change in quality of life(Quality of Life Enjoyment and Satisfaction Questionnaire - QLESQ-SF & Quality of Life Scale - QLS)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandre Dumais, MD, PhD

CONTACT

[email protected]

514-251-4000 ext. 3212

Sponsors and collaborators

Lead sponsor

Ciusss de L'Est de l'Île de Montréal

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Acronym: AC2

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jan 30, 2023
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.