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Contingency Management for Psychosis
N/A
Recruiting
Led By Rachel Rabin, Ph. D.
Research Sponsored by Douglas Mental Health University Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must not have
Taking psychotropic medication
Head injury requiring hospitalization or loss of consciousness > 5 minutes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 28
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the brain changes of people with psychosis who stop using cannabis for 28 days, compared to a control group who continue using.
Who is the study for?
This trial is for adults who use cannabis heavily and either have psychosis or no psychiatric conditions. Participants must speak English or French, have an IQ over 75, and be stable on medications if they have psychosis. They can't join if they use other psychoactive substances, are suicidal, pregnant, need hospitalization for medical issues, take psychotropic meds (except those with psychosis), or have MRI contraindications.
What is being tested?
The study examines how stopping cannabis affects brain function in people with and without psychosis over 28 days. It involves random assignment to a group that quits using cannabis or a control group that continues as usual. Brain changes will be monitored using MRI scans before and after the abstinence period.
What are the potential side effects?
There may not be direct side effects from the interventions since this trial focuses on observing changes during cannabis abstinence rather than testing a drug; however, participants might experience withdrawal symptoms like irritability, sleep problems, cravings for cannabis or mood swings.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medication for my mental health.
Select...
I have been hospitalized for a head injury or was unconscious for more than 5 minutes.
Select...
I have a medical condition that needs regular hospital visits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 28
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in behavior during fMRI task
Change in fMRI brain activity pattern
Secondary study objectives
Change in brain morphology: cortical thickness
Change in brain morphology: diffusion
Change in brain morphology: gray matter volume
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Psychosis patients with cannabis use (Abstinent)Experimental Treatment1 Intervention
Psychosis patients with cannabis use will receive contingency management to encourage cannabis abstinence for 28 days
Group II: Non-Psychiatric controls with cannabis use (Abstinent)Experimental Treatment1 Intervention
Non-Psychiatric controls with cannabis use will receive contingency management to encourage cannabis abstinence for 28 days
Group III: Psychosis patients with cannabis use (Non-abstinent)Active Control1 Intervention
Psychosis Patients with cannabis use who will continue to use cannabis as usual
Group IV: Non-Psychiatric controls with cannabis use (Non-abstinent)Active Control1 Intervention
Non-Psychiatric Controls with cannabis use will continue to use cannabis as usual
Group V: Non-Psychiatric Controls without cannabis useActive Control1 Intervention
Non-Psychiatric controls without cannabis use
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Contingency management
2006
Completed Phase 4
~1020
Find a Location
Who is running the clinical trial?
Douglas Mental Health University InstituteLead Sponsor
29 Previous Clinical Trials
2,614 Total Patients Enrolled
Rachel Rabin, Ph. D.Principal InvestigatorDouglas Mental Health University Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking medication for my mental health.You cannot have an MRI scan due to certain medical reasons.I have been hospitalized for a head injury or was unconscious for more than 5 minutes.I have been on a stable dose of my psychosis medication for at least two months.You have been diagnosed with a mental health condition, other than cannabis use disorder. This criterion only applies to participants without any mental health conditions.You are currently having thoughts of hurting yourself or others.I have a medical condition that needs regular hospital visits.I can give my consent in English or French.You currently have a substance use disorder, except for cannabis use disorder.You have been using cannabis heavily for at least six months (using it weekly) or have been diagnosed with cannabis use disorder (CUD) according to the DSM-5 guidelines.You have been diagnosed with a serious mental illness that causes hallucinations or delusions.
Research Study Groups:
This trial has the following groups:- Group 1: Psychosis patients with cannabis use (Non-abstinent)
- Group 2: Non-Psychiatric controls with cannabis use (Abstinent)
- Group 3: Non-Psychiatric controls with cannabis use (Non-abstinent)
- Group 4: Non-Psychiatric Controls without cannabis use
- Group 5: Psychosis patients with cannabis use (Abstinent)
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.