Recruiting

Avatar Intervention vs. Supportive Intervention

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT05704582

Conditions

Psychotic Disorders

Cannabis Use Disorder

Mental Health Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Avatar Intervention

Addiction supportive intervention

Study Details

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.

Conditions

Psychotic Disorders

Cannabis Use Disorder

Mental Health Disorder

Study ID

NCT05704582

Start date

Feb 1, 2023

Status verified date

Feb, 2024

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

Avatar Intervention

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

Addiction supportive intervention

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Alexandre Dumais, MD, PhD

514-251-4000contact@avatar-intervention.ca

Locations

Research center of the Institut universitaire en santé mentale de Montréal

Recruiting

Montreal, Quebec, Canada, H1N 3M5

Principal Investigator:

Alexandre Dumais, MD, PhD

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Feb 7, 2024

Last verified

Feb, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2024-02-07.