Psychotic DisordersAC2NCT05704582
RCT Comparing Avatar Intervention to Supportive Intervention to Reduce Cannabis Use in Patients With Psychotic Disorders
A study testing Avatar Intervention and Addiction supportive intervention in people with Psychotic Disorders and Cannabis Use Disorder, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotic Disorders, Cannabis Use Disorder, Mental Health Disorder
- What is being tested?
- Avatar Intervention and Addiction supportive intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2023to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Research center of the Institut universitaire en santé mentale de Montréal
Montreal, Quebec, H1N 3M5
Alexandre Dumais, MD, PhD
Alexandre Dumais, MD, PhD
About this study
Official title: A Randomized Controlled Trial Comparing Avatar Intervention to an Addiction 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.
Read the 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.
- Being tested
- Avatar Intervention, Addiction supportive intervention
- Keywords
- cannabis, virtual reality intervention, psychotic disorders, substance use disorders
- Medical subject headings
- Psychotic Disorders, Mental Disorders, Marijuana Abuse, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avatar InterventionOther
Also called Avatar-CUD
8 weekly sessions of 60 minutes. Possibility of 4 additional sessions.
Addiction supportive interventionOther
8 weekly sessions of 60 minutes. Possibility of 4 additional sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Addiction supportive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
16-item self-reported questionnaire assessing cannabis use and dependence; Range 3-82, higher values indicating a more severe cannabis use disorder
Measured: 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)
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
Measured: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Feb 2023
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-blind randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Alexandre Dumais, MD, PhD, Principal investigator, University of Montreal, Institut universitaire en santé mentale de MontréalStephane Potvin, PhD, Principal investigator, University of Montreal, Institut universitaire en santé mentale de MontréalEmmanuel Stip, MD, MSc, Study chair, United Arab Emirates UniversityAmal Abdel Baki, MD, MSc, Study chair, University of Montreal, Centre hospitalier de l'Université de MontréalRobert-Paul Juster, PhD, Study chair, University of Montreal, Institut universitaire en santé mentale de MontréalMarie-Hélène Goulet, PhD, Study chair, University of Montreal, Institut universitaire en santé mentale de MontréalLuigi De Benedictis, MD, Study chair, Institut universitaire en santé mentale de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704582
- Sponsor's protocol ID
- MP-12-2023-3234
- Acronym
- AC2
- Status last verified
- Feb 2024
- First submitted
- 20 Jan 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Avatar Intervention to an Addiction Supportive Intervention to Reduce Cannabis Use in Patients With Psychotic Disorders
- ClinicalTrials.gov ID
- NCT05704582
- Acronym / sponsor ID
- AC2 / MP-12-2023-3234
- Keywords
- cannabis, virtual reality intervention, psychotic disorders, substance use disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Avatar Intervention | Experimental | Other: Avatar InterventionThe 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. |
| Addiction supportive intervention | Active comparator | Other: Addiction supportive interventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avatar InterventionAlso: Avatar-CUD8 weekly sessions of 60 minutes. Possibility of 4 additional sessions. | Other | Avatar Intervention |
| Addiction supportive intervention8 weekly sessions of 60 minutes. Possibility of 4 additional sessions. | Other | Addiction supportive intervention |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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 study chair
United Arab Emirates University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avatar Intervention and Addiction supportive intervention in people with Psychotic Disorders and Cannabis Use Disorder, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Dumais, MD, PhD (514-251-4000 ext. 3212, contact@avatar-intervention.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024; AzTrials last refreshed its copy on 1 Nov 2026.