Avatar Therapy vs Supportive Care for Cannabis Use in Psychotic Disorders

(AC2 Trial)

Overseen By Alexandre Dumais, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ciusss de L'Est de l'Île de Montréal

Disqualifiers: Neurological disorders, Severe illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if virtual reality avatars can more effectively help people with psychotic disorders reduce cannabis use compared to traditional support programs. Participants will either receive support sessions focused on reducing cravings (addiction supportive intervention) or engage in an avatar-based approach (avatar intervention) that also targets cravings through virtual reality. The trial seeks individuals over 18 diagnosed with cannabis use disorder and a psychotic disorder, such as schizophrenia or bipolar disorder. As an unphased trial, participants contribute to innovative research that may provide new methods for managing cravings.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are receiving ongoing treatment for cannabis use disorder, you may not be eligible to participate.

What prior data suggests that the Avatar Intervention is safe for reducing cannabis use in patients with psychotic disorders?

Research shows that the Avatar Intervention is generally well-tolerated by individuals with cannabis use and psychotic disorders. Early results from similar studies indicate that participants using virtual reality and avatars in therapy did not experience major negative side effects, suggesting the treatment is safe. These studies have used virtual reality to help reduce cannabis cravings. During sessions, participants interact with computer-generated characters, or avatars. So far, no significant safety concerns have been reported, suggesting that the Avatar Intervention is likely a safe option for those seeking to reduce cannabis use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for cannabis use in psychotic disorders, which often includes counseling and behavioral therapies, Avatar Intervention uses virtual reality and avatars to help reduce cravings. This innovative approach allows patients to interact with personalized avatars in a virtual environment, which can make therapy more engaging and immersive. Researchers are excited about this method because it offers a new way to tackle addiction, potentially enhancing motivation and improving outcomes through an interactive and personalized experience.

What evidence suggests that this trial's treatments could be effective for reducing cannabis use in psychotic disorders?

Research has shown that the Avatar Intervention, a treatment in this trial, uses virtual reality and digital characters to assist individuals with cannabis use disorder (CUD). One study found this method more engaging and effective than traditional treatments due to its interactive and personal experiences. Early results suggest that the virtual reality component helps individuals better understand and manage their cravings. Avatars enhance the treatment by providing a more relatable and immersive experience.

In contrast, the addiction supportive intervention, another treatment arm in this trial, focuses on reducing cravings through regular therapy sessions. While generally helpful, it lacks the interactive and immersive features of the Avatar Intervention. This suggests that the Avatar Intervention might offer a new way to assist individuals with cannabis use who also have psychotic disorders. ^{1 2 3 6 7}

Who Is on the Research Team?

Alexandre Dumais, MD, PhD

Principal Investigator

University of Montreal, Institut universitaire en santé mentale de Montréal

Stephane Potvin, PhD

Principal Investigator

University of Montreal, Institut universitaire en santé mentale de Montréal

Emmanuel Stip, MD, MSc

Principal Investigator

United Arab Emirates University

Robert-Paul Juster, PhD

Principal Investigator

University of Montreal, Institut universitaire en santé mentale de Montréal

Marie-Hélène Goulet, PhD

Principal Investigator

University of Montreal, Institut universitaire en santé mentale de Montréal

Luigi De Benedictis, MD

Principal Investigator

Institut universitaire en santé mentale de Montréal

Amal Abdel Baki, MD, MSc

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for adults over 18 with schizophrenia, schizoaffective disorder, or bipolar disorder with psychotic symptoms who also have a cannabis use problem. They must not be currently treated for other substance use disorders, detoxing from cannabis, have neurological issues or severe physical illnesses.

Inclusion Criteria

I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder with psychotic symptoms.

Exclusion Criteria

Ongoing pharmacological or psychological treatment for CUD

Ongoing detoxification for cannabis withdrawal

Current SUD for a substance other than cannabis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Avatar Intervention or Addiction Supportive Intervention over 8 weeks, with one session per week and optional additional sessions

8 weeks

8-12 visits (in-person)

Follow-up

Participants are monitored for changes in cannabis use, disorder severity, and quality of life at multiple intervals post-treatment

12 months

Follow-ups at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Addiction supportive intervention
• Avatar Intervention

Trial Overview The study is testing if an 'Avatar Intervention' is more effective than standard supportive care in helping people with psychotic disorders reduce their cannabis use. Participants are randomly assigned to one of the two interventions without knowing which one they're getting.

How Is the Trial Designed?

Group I: Avatar Intervention Experimental Treatment 1 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.

Group II: Addiction supportive intervention Active Control 1 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.

Addiction supportive intervention is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Supportive Intervention for:

• Substance Use Disorders
• Addiction Treatment

Approved in European Union as Addiction Counseling for:

• Substance Abuse
• Psychological Disorders

Approved in Canada as Therapeutic Intervention for:

• Addiction Recovery
• Mental Health Disorders

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials

81

Recruited

6,400+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

AVATAR therapy significantly reduced the severity of persistent auditory verbal hallucinations compared to supportive counselling, with a mean difference in scores indicating a large effect size after 12 weeks of treatment in a study involving 150 participants.

No adverse events were reported for either AVATAR therapy or supportive counselling, suggesting that AVATAR therapy is a safe intervention for individuals experiencing these hallucinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AVATAR therapy for auditory verbal hallucinations in people with psychosis: a single-blind, randomised controlled trial. Craig, TK., Rus-Calafell, M., Ward, T., et al.[2019]

Practitioners and researchers believe that Virtual Reality Therapy (VRT) could be a valuable addition to treating Substance Use Disorders (SUDs), as it offers safe and realistic exposure to triggering scenarios.

VRT is seen as beneficial for adults and those with mental health issues, with the potential to enhance therapy by allowing the inclusion of avatars and observing reactions, although risks like relapse and over-confidence need to be managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Views of Practitioners and Researchers on the Use of Virtual Reality in Treatments for Substance Use Disorders. Skeva, R., Gregg, L., Jay, C., et al.[2021]

AVATAR therapy is an innovative treatment that allows individuals to engage in face-to-face dialogue with a digital avatar representing their distressing voices, showing promise in addressing these experiences.

This article provides a comprehensive overview of the therapy's delivery, therapeutic targets, acceptability, and potential side effects, highlighting its growing interest and importance for future research and development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AVATAR Therapy for Distressing Voices: A Comprehensive Account of Therapeutic Targets. Ward, T., Rus-Calafell, M., Ramadhan, Z., et al.[2023]

Avatar therapy (AT) for treatment-resistant schizophrenia involves patients interacting with an Avatar that represents their auditory hallucinations, revealing important therapeutic dynamics.

Analysis of 256 interactions from 32 patients identified five key dyadic interactions that occurred frequently, suggesting that these dynamics may play a crucial role in the effectiveness of the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dyadic Interactions of Treatment-Resistant Schizophrenia Patients Having Followed Virtual Reality Therapy: A Content Analysis. Hudon, A., Couture, J., Dellazizzo, L., et al.[2023]

Combining cognitive behavioral therapy (CBT) with virtual reality-assisted therapy (VRT) showed significant improvements in symptoms for treatment-resistant schizophrenia patients, particularly in auditory hallucinations and depressive symptoms.

The study, involving 10 participants who had previously undergone CBT, suggests that the combination of CBT and VRT may have a synergistic effect, leading to greater improvements than either therapy alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Benefits of Virtual Reality-Assisted Therapy Following Cognitive-Behavioral Therapy for Auditory Hallucinations in Patients with Treatment-Resistant Schizophrenia: A Proof of Concept. Dellazizzo, L., Potvin, S., Phraxayavong, K., et al.[2023]

A pilot clinical trial involving 19 participants with cannabis use disorder and severe mental disorder showed that an innovative avatar intervention led to a significant moderate reduction in cannabis use, with a Cohen's d of 0.611, indicating effectiveness.

The intervention utilized immersive virtual reality techniques, allowing participants to practice therapeutic methods in real-time, suggesting that this novel approach could enhance treatment outcomes for cannabis use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avatar Intervention for Cannabis Use Disorder in Individuals with Severe Mental Disorders: A Pilot Study. Giguère, S., Potvin, S., Beaudoin, M., et al.[2023]

A twelve-week intervention targeting both cannabis use disorders (CUD) and tobacco smoking showed that all six participants completed the cannabis treatment, and five achieved abstinence from cannabis, indicating that simultaneous treatment can be effective for cannabis outcomes.

While participation in the tobacco intervention was high, with 50% of participants starting nicotine replacement therapy, the actual quit attempts for tobacco were lower than expected, suggesting that more effective strategies are needed to improve tobacco cessation rates alongside CUD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment models for targeting tobacco use during treatment for cannabis use disorder: case series. Lee, DC., Budney, AJ., Brunette, MF., et al.[2021]

This study aims to evaluate the effectiveness of combining cognitive behavioral therapy (CBT) with virtual reality exposure therapy (VRET) for preventing smoking relapse, with 120 participants (60 in each group) over a 14-month period.

The primary outcome will measure tobacco abstinence at 6 months post-therapy, potentially demonstrating that VRET can enhance the effectiveness of traditional CBT in relapse prevention, which could lead to easier implementation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial. Giovancarli, C., Malbos, E., Baumstarck, K., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11612600/

Avatar Intervention in Virtual Reality for Cannabis Use ... Our research team developed avatar intervention, an approach using virtual reality as a therapeutic tool to treat CUD in individuals with SMD.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05726617

Avatar Intervention for the Treatment of Cannabis Use ... This is a proof-of-concept of a new Virtual Reality (VR) Avatar Intervention for Cannabis Use Disorders (CUD) in patients with psychotic disorders and/or mood ...

3. mdpi.com mdpi.com/2075-4426/13/5/766

Avatar Intervention for Cannabis Use Disorder in ... Available interventions are at best slightly effective, and their effects are not maintained over time. Therefore, the integration of virtual reality (VR) may ...

4. ctv.veeva.com ctv.veeva.com/study/rct-comparing-avatar-intervention-to-supportive-intervention-to-reduce-cannabis-use-in-patients-with

RCT Comparing Avatar Intervention to Supportive Intervention ... The Avatar Intervention displays strong experiential and relational components that are crucially missing in conventional interventions. Hence, ...

5. interventions-avatar.ca interventions-avatar.ca/publications/

Publications Avatar Intervention in Virtual Reality for Cannabis Use Disorder in Individuals With Severe Mental Disorders: Results From a 1-Year, Single-Arm Clinical Trial.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05704582

RCT Comparing Avatar Intervention to Supportive ... 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. Intervention/ ...

7. withpower.com withpower.com/trial/phase-disease-8-2019-dd6c3

Avatar Therapy for Cannabis Use Disorder ... This is a proof-of-concept of a new Virtual Reality (VR) Avatar Intervention for Cannabis Use Disorders (CUD) in patients with psychotic disorders and/or ...