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

NCT05704582 | Recruiting DMC

• 1 other identifier: MP-12-2023-3234
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in cannabis use (Timeline Follow-Back)

  A standardized tool consisting of asking the patients how many joints they smoked each day of the week during the past week.

  Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

Avatar Intervention

EXPERIMENTAL

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.

Other: Avatar Intervention

Addiction supportive intervention

ACTIVE COMPARATOR

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.

Other: Addiction supportive intervention

Interventions

Avatar Intervention OTHER

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

Also known as: Avatar-CUD

Avatar Intervention

Addiction supportive intervention OTHER

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

Addiction supportive intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Research center of the Institut universitaire en santé mentale de Montréal

Montreal, Quebec, H1N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Mental Disorders; Marijuana Abuse; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Chemically-Induced Disorders

Study Officials

• Alexandre Dumais, MD, PhD

  University of Montreal, Institut universitaire en santé mentale de Montréal

  PRINCIPAL INVESTIGATOR

• Stephane Potvin, PhD

  University of Montreal, Institut universitaire en santé mentale de Montréal

  PRINCIPAL INVESTIGATOR

• Emmanuel Stip, MD, MSc

  United Arab Emirates University

  STUDY CHAIR

• Amal Abdel Baki, MD, MSc

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

  STUDY CHAIR

• Robert-Paul Juster, PhD

  University of Montreal, Institut universitaire en santé mentale de Montréal

  STUDY CHAIR

• Marie-Hélène Goulet, PhD

  University of Montreal, Institut universitaire en santé mentale de Montréal

  STUDY CHAIR

• Luigi De Benedictis, MD

  Institut universitaire en santé mentale de Montréal

  STUDY CHAIR

Central Study Contacts

Alexandre Dumais, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blind randomized controlled trial

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 30, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)