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CHAMPS for Psychosis (CHAMPS Trial)
N/A
Waitlist Available
Led By Didier Jutras-Aswad, MD, MSc
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks -2-0 (baseline), 6, 12 and 18
Awards & highlights
CHAMPS Trial Summary
This trial is testing an app called CHAMPS that gives cannabis users strategies for safer use. The goals of the study are to see if the app is acceptable to users and if it has positive impacts on their health and cannabis consumption habits.
Eligible Conditions
- Psychosis
- Cannabis Use
- Young Adults
CHAMPS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks -2-0 (baseline), 6, 12 and 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks -2-0 (baseline), 6, 12 and 18
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Completion rates
Retention rates
Secondary outcome measures
Acceptability (CHAMPS usage data)
Efficacy (motivation to change cannabis protective behavioral strategies)
Efficacy (use of cannabis protective behavioral strategies)
+2 moreOther outcome measures
Cannabis use
Cannabis-related problems
Health service utilization
+5 moreCHAMPS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CHAMPS and EISExperimental Treatment1 Intervention
The Cannabis Harm-reducing App for Managing Practices Safely (CHAMPS) is a brief harm reduction e-intervention based on the principles of motivational interviewing and harm reduction approaches. This e-intervention will be completed by the participant using a smart phone. There will be a total of six individual sessions each lasting 15-20 min. There will be one booster session offered at 4 weeks post-intervention to review goal setting, evaluate motivation around changing cannabis use practices. This e-intervention will be administered adjunctively to psychosis early intervention services (EIS).
Group II: EIS aloneActive Control1 Intervention
Early intervention services (EIS) for psychosis will be offered as per standard of care at participating clinical sites. Theses services vary but typically include pharmacotherapy and individual and/or group psychotherapy. Any visits and services offered in the EIS arm will be considered 'usual care' and administered either through in-person clinic visits, phone calls, or video calls. Relevant service information will be collected for study purposes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CHAMPS
2010
N/A
~700
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Who is running the clinical trial?
Ministere de la Sante et des Services SociauxOTHER
17 Previous Clinical Trials
78,032 Total Patients Enrolled
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
370 Previous Clinical Trials
129,768 Total Patients Enrolled
Didier Jutras-Aswad, MD, MScPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
1 Previous Clinical Trials
100 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used cannabis at least once in the last 4 weeks.You are able to comply with study procedures.You are willing to adjust your use of cannabis.You cannot participate in the study if you have any of these conditions:You are currently receiving help from a therapist or taking medication to reduce or stop your use of cannabis.You are currently involved in another study that focuses on cannabis.You have been diagnosed with a mental disorder that can cause hallucinations or delusions, such as schizophrenia or bipolar disorder with psychotic features.You have been diagnosed with a mental disorder that can cause hallucinations or severe disturbances in thinking and behavior.You have used cannabis within the past 4 weeks.You are willing to make changes to your cannabis-related habits.
Research Study Groups:
This trial has the following groups:- Group 1: EIS alone
- Group 2: CHAMPS and EIS
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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