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View on ClinicalTrials.gov

Testing Contingency management for psychotic disorders

Official title: Investigating the Neural Correlates of Cognitive Function in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use

Investigating the Neural Correlates of Cognitive Function Associated With Cannabis Abstinence in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use

Condition: Psychotic DisordersSponsor: Douglas Mental Health University InstituteTarget enrollment: 134
  • 5 groups
  • One site, in Montreal
  • Recruiting
Douglas Mental Health University Institute, Montreal, Quebec

Interventions

  • Behavioural therapy

    Contingency management

    Contingency management will be used to encourage abstinence

Canadian Sites (1)

1 of 1 recruiting

  • Douglas Mental Health University Institute

    Montreal, Quebec

    Recruiting

Eligibility Criteria

See who this study is looking for15 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Able to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → in English or French
  • +Heavy cannabis use (defined as weekly cannabis use for at six months) and/or DSM-5 diagnosis of CUD
  • +Have a Full-Scale IQ ≥ 75
  • +Meet DSM-5 criteria for a psychotic disorder (psychosis patient armArmOne of the groups in a study, each receiving something different.Read more → only)
  • +Be an outpatient receiving a stable dose of medication(s) for at least two months (psychosis patient arm only)
  • +Clinically stable (as measured by the PANSS-6, total score \<30) (psychosis patient arm only)

Exclusion

  • current SUD (other than CUD)
  • MRI contraindications
  • Current suicidal or homicidal ideation
  • Head injury requiring hospitalization or loss of consciousness \> 5 minutes
  • Current medical diseases that requires hospitalization or regular monitoring
  • DSM-5 Axis 1 diagnosis (other than CUD) (non-psychiatric controlsControl groupThe group a new treatment is measured against.Read more → only)
  • Taking psychotropic medication
  • Being pregnant
  • Positive urine screen for psychoactive substances other than cannabis, nicotine, or caffeine
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is investigating how something functions in the body, rather than testing a treatment directly.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 5 groups in this study.

Groups A and C receive Contingency management.

Registry label: A: Psychosis patients with cannabis use (Abstinent) · C: Non-Psychiatric controls with cannabis use (Abstinent)

Groups B, D and E receive no study treatment and are followed for comparison.

Registry label: B: Psychosis patients with cannabis use (Non-abstinent) · D: Non-Psychiatric controls with cannabis use (Non-abstinent) · E: Non-Psychiatric Controls without cannabis use

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

One group of people involved — usually the participants — is not told which treatment is which.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives no study treatment at all, and is followed for comparison.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists an age range of 16 years to 80 years.

The study is open to people of any sex.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 134 people.

The study is currently expected to finish around May 2027.

The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, Day 28.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Change in fMRI brain activity pattern — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, Day 28.

Change in behavior during fMRI task — measured over Baseline, Day 28.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT05445180 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Contingency managementBehavioural

Contingency management will be used to encourage abstinence

From the trial registry — its own words, unedited.

What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 16 years to 80 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives no study treatment and is followed for comparison.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

One group of people involved — usually the participants — is not told which treatment is which.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists an age range of 16 years to 80 years.

It is open to people of any sex.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, Day 28.

The study as a whole is currently expected to finish around 2027-05.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 134 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Montreal, Quebec, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

Cognitive impairment is well established in people with psychosis and is associated with cannabis use. The current study will investigate the neurobiological basis of cognitive change associated with 28-days of cannabis abstinence in people with psychosis and non-psychiatric controls with cannabis use. Participants will be randomized to a cannabis abstinent group or a non-abstinent control group and will undergo magnetic resonance imaging at baseline and following 28-days of abstinence. This study will help characterize the neuropathophysiological processes underlying cognitive dysfunction associated with cannabis use and its recovery which may guide the development of novel interventions for problematic cannabis use.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.