Psychotic DisordersAvatar-CUDNCT05726617
Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Severe Mental Health Disorders
A study testing Avatar 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
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 disorders. The primary outcomes are reductions in cannabis use, cannabis use disorder severity, and increased quality of life. 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 24 Sep 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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, bipolar disorder and major depression. Diagnoses will be established with the Structured Interview for DSM-5 (SCID-5).
Who cannot join
- 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.
Canada1 site
Research center of the Institut universitaire en santé mentale de Montréal
Montreal, Quebec, H1N 3M5
About this study
Official title: A Pilot Study : Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Psychotic Disorders and/or Mood Disorders
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 disorders. The primary outcomes are reductions in cannabis use, cannabis use disorder severity, and increased quality of life.
Read the detailed description
Cannabis use disorder (CUD) is a complex issue, even more so when it is comorbid with a psychotic disorder or a mood disorder. Indeed, this population seems more vulnerable to this substance since the incidence of developing CUD is five to six times higher compared to the general population. In these populations, cannabis use is one of the key factors leading to psychiatric re-hospitalization. It is 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 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 concepts. In response to this clinical need, our team has created a distinctive intervention for CUD in patients with psychotic disorders and/or mood disorders. The Avatar Intervention displays strong experiential and relational components that are crucially missing in conventional interventions. This proposal thus aims to conduct a proof-of-concept to assess the efficacity of Avatar Intervention for CUD in patients with psychotic disorders and/or mood disorders. The primary objective of this open trial will be to determine whether cannabis-related outcomes (i.e. frequency and quantity of use) diminish after treatment as well as 3- 6- and 12-months follow-up. As for secondary objectives, the investigator will seek to determine the effect of the intervention on motivation to change, severity of cannabis dependence, psychiatric symptoms (mood and psychotic) and whether quality of life improves after treatment, at 3- 6- and 12-months follow-up. As there is no evidence-based therapeutic options for CUD in patients with psychotic disorders and/or mood disorders, the current trial will contribute to the validation of a novel approach and create new therapeutic possibilities.
- Being tested
- Avatar 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 InterventionBehavioural
Also called Avatar-CUD
8 weekly sessions of 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Avatar Intervention | Experimental | The Avatar Intervention will take place over 8 consecutive weeks, with one session per week. 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: Behavioral: Avatar 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 as well as 3- 6- and 12-months follow-up
Secondary outcomes (4)
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 as well as 3- 6- and 12-months follow-up
Change in quality of life (Quality of Life Scale -QLS)
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 as well as 3- 6- and 12-months follow-up
Motivation to change cannabis use (Marijuana Ladder)
Diagram of a ladder with 10 "rungs," several of which are anchored by verbal labels of different degrees of readiness to change (pre-contemplation, contemplation, preparation, action, maintenance); higher values indicates a high degrees of readiness to change
Measured: Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up
Change in psychiatric symptoms (Positive And Negative Syndrome Scale - PANSS)
Positive And Negative Syndrome Scale: 30-item semi-structured interview investigating overall symptoms severity of schizophrenia in the last week; Subscales: Positive (7-49), Negative (7-49), General (16-112), Total score (subscales summed; 30-210); higher value indicates a worse symptomatology
Measured: Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start24 Sep 2019
- Primary completion11 Aug 2022
- Study completion31 Dec 2024 (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
- Not applicable
- Intervention model
- Single group
- Model description
- pilot clinical trial, single arm
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Dumais, MD, PhD, Principal investigator, University of Montreal, Institut universitaire en santé mentale de MontréalStéphane Potvin, PhD, Principal investigator, University of Montreal, Institut universitaire en santé mentale de MontréalRobert-Paul Juster, Study chair, University of Montreal, Institut universitaire en santé mentale de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726617
- Sponsor's protocol ID
- MP-12-2019-1564
- Acronym
- Avatar-CUD
- Status last verified
- Feb 2024
- First submitted
- 3 Feb 2023
- Last updated
- 20 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study : Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Psychotic Disorders and/or Mood Disorders
- ClinicalTrials.gov ID
- NCT05726617
- Acronym / sponsor ID
- Avatar-CUD / MP-12-2019-1564
- Keywords
- cannabis, virtual reality intervention, psychotic disorders, substance use disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Feb 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.
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 disorders. The primary outcomes are reductions in cannabis use, cannabis use disorder severity, and increased quality of life.
Detailed description
Cannabis use disorder (CUD) is a complex issue, even more so when it is comorbid with a psychotic disorder or a mood disorder. Indeed, this population seems more vulnerable to this substance since the incidence of developing CUD is five to six times higher compared to the general population. In these populations, cannabis use is one of the key factors leading to psychiatric re-hospitalization. It is 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 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 concepts. In response to this clinical need, our team has created a distinctive intervention for CUD in patients with psychotic disorders and/or mood disorders. The Avatar Intervention displays strong experiential and relational components that are crucially missing in conventional interventions. This proposal thus aims to conduct a proof-of-concept to assess the efficacity of Avatar Intervention for CUD in patients with psychotic disorders and/or mood disorders. The primary objective of this open trial will be to determine whether cannabis-related outcomes (i.e. frequency and quantity of use) diminish after treatment as well as 3- 6- and 12-months follow-up. As for secondary objectives, the investigator will seek to determine the effect of the intervention on motivation to change, severity of cannabis dependence, psychiatric symptoms (mood and psychotic) and whether quality of life improves after treatment, at 3- 6- and 12-months follow-up. As there is no evidence-based therapeutic options for CUD in patients with psychotic disorders and/or mood disorders, the current trial will contribute to the validation of a novel approach and create new therapeutic possibilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pilot clinical trial, single arm
| Arm | Type | Receives |
|---|---|---|
| Experimental: Avatar Intervention | Experimental | Behavioral: Avatar InterventionThe Avatar Intervention will take place over 8 consecutive weeks, with one session per week. 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. |
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, bipolar disorder and major depression. Diagnoses will be established with the Structured Interview for DSM-5 (SCID-5).
Key exclusion criteria (5 listed)
- 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.
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. | Behavioural | Experimental: Avatar Intervention |
Primary outcome
Change in cannabis use (Timeline Follow-Back)
Time frame: Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up
A standardized tool consisting of asking the patients how many joints they smoked each day of the week during the past week.
4 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 as well as 3- 6- and 12-months follow-up
Change in quality of life (Quality of Life Scale -QLS)
Time frame: Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up
Motivation to change cannabis use (Marijuana Ladder)
Time frame: Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up
Change in psychiatric symptoms (Positive And Negative Syndrome Scale - PANSS)
Time frame: Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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. This study is not recruiting at the moment.
Alexandre Dumais, MD, PhD principal investigator
University of Montreal, Institut universitaire en santé mentale de Montréal
Stéphane Potvin, PhD principal investigator
University of Montreal, Institut universitaire en santé mentale de Montréal
Robert-Paul Juster study chair
University of Montreal, Institut universitaire en santé mentale de Montréal
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 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 5 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: status not confirmed, as of the sponsor's last update on 20 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 as well as 3- 6- and 12-months follow-up). 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 20 Feb 2024.