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Avatar Therapy vs Supportive Care for Cannabis Use in Psychotic Disorders (AC2 Trial)
N/A
Recruiting
Led By Stephane Potvin, PhD
Research Sponsored by Ciusss de L'Est de l'Île de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare two interventions to reduce cannabis use in people with psychotic disorders to see which works better. Results will show if it reduces cannabis use, cannabis use disorder severity, and improves quality of life.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves psychological interventions rather than medications, side effects may include emotional discomfort or distress related to discussing personal issues and confronting cannabis use habits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in cannabis use (Timeline Follow-Back)
Secondary study objectives
Change in quality of life(Quality of Life Enjoyment and Satisfaction Questionnaire - QLESQ-SF & Quality of Life Scale - QLS)
Change in the severity of the cannabis use disorder (Cannabis Use Problems Identification Test - CUPIT)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Avatar InterventionExperimental Treatment1 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 interventionActive Control1 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.
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Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,517,923 Total Patients Enrolled
4 Trials studying Psychosis
715 Patients Enrolled for Psychosis
Ciusss de L'Est de l'Île de MontréalLead Sponsor
78 Previous Clinical Trials
6,265 Total Patients Enrolled
Stephane Potvin, PhDPrincipal InvestigatorUniversity of Montreal, Institut universitaire en santé mentale de Montréal
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a severe and unstable illness.I am unable to give consent by myself.I am over 18 and diagnosed with moderate to severe cannabis use disorder.I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder with psychotic symptoms.I have a neurological disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Addiction supportive intervention
- Group 2: Avatar Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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