Psychotic DisordersNCT05445180
Investigating the Neural Correlates of Cognitive Function in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use
A study testing Contingency management in people with Psychotic Disorders and Cannabis Use Disorder, run by Douglas Mental Health University Institute at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychotic Disorders, Cannabis Use Disorder, Cannabis Dependence
- What is being tested?
- Contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteCanada
- Study dates
- 21 Apr 2022to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Able to provide informed consent 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 arm 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)
Who cannot join
- current SUD (other than CUD)
- MRI contraindications
- Positive urine screen for psychoactive substances other than cannabis, nicotine, or caffeine
- Current suicidal or homicidal ideation
- Head injury requiring hospitalization or loss of consciousness > 5 minutes
- Current medical diseases that requires hospitalization or regular monitoring
Show all 9Show fewer
- Being pregnant
- DSM-5 Axis 1 diagnosis (other than CUD) (non-psychiatric controls only)
- Taking psychotropic medication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Douglas Mental Health University Institute
Montreal, Quebec, H4H 1R3
Research Coordinator, (514) 761-6131 ext. 3348, aimh.research@gmail.com
Rachel Rabin, Ph. D.
About this study
Official title: Investigating the Neural Correlates of Cognitive Function Associated With Cannabis Abstinence in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use
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.
Read the detailed description
Background/Importance: Cognitive impairment is well established in people with psychosis and is associated with cannabis use. Despite high rates of cannabis use among people with psychosis and the general population, cannabis' effects on cognition and the brain and their recovery remain unclear. Therefore, this study will investigate the neurobiological basis of changes in cognitive processes associated with cannabis abstinence in people with psychosis and non-psychiatric controls.
Aims: To examine the effects of 28-days of cannabis abstinence in psychosis patients with cannabis use and non-psychiatric controls with cannabis use on (i) brain activity (paired with a memory task); (ii) brain morphology; (iii) to determine if changes in memory following 28-days of abstinence correlate with changes in brain activity and/or morphology and (iv) to determine if baseline brain function and morphology can predict successful abstinence.
Methods: Seventy-four psychosis patients with cannabis use and 60 non-psychiatric controls with cannabis use will be randomized to: (1) contingency reinforcement where biochemically verified abstinence at day 28 will be rewarded; or (2) a non-abstinent control group. The investigators will also recruit a group of healthy non-psychiatric controls (n=40) to determine if neural outcomes in cannabis-using participants do indeed normalize ("recover") following abstinence. Participants will undergo structural and functional magnetic resonance imaging while completing a memory task at baseline (pre-abstinence) and following 28-days of abstinence. Urine samples will be collected twice weekly for abstinence verification.
Relevance: This study will help to characterize the neuropathophysiological processes underlying cognitive dysfunction associated with cannabis use in people with psychosis and non-psychiatric controls which may help to guide the development of novel neurobiologically-informed interventions to treat problematic cannabis use.
- Conditions
- Psychotic Disorders, Cannabis Use Disorder, Cannabis Dependence, Cannabis Use, Schizophrenia; Psychosis, Cognitive Dysfunction
- Being tested
- Contingency management
- Medical subject headings
- Psychotic Disorders, Marijuana Abuse, Schizophrenia, Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency managementBehavioural
Contingency management will be used to encourage abstinence
| Study group | Role | What they receive |
|---|---|---|
| Psychosis patients with cannabis use (Abstinent) | Experimental | Psychosis patients with cannabis use will receive contingency management to encourage cannabis abstinence for 28 days Receives: Behavioral: Contingency management |
| Psychosis patients with cannabis use (Non-abstinent) | No intervention | Psychosis Patients with cannabis use who will continue to use cannabis as usual |
| Non-Psychiatric controls with cannabis use (Abstinent) | Experimental | Non-Psychiatric controls with cannabis use will receive contingency management to encourage cannabis abstinence for 28 days Receives: Behavioral: Contingency management |
| Non-Psychiatric controls with cannabis use (Non-abstinent) | No intervention | Non-Psychiatric Controls with cannabis use will continue to use cannabis as usual |
| Non-Psychiatric Controls without cannabis use | No intervention | Non-Psychiatric controls without cannabis use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fMRI brain activity pattern
fMRI will be used to measure differences between baseline (day 0) and day 28 in hemodynamic (BOLD) responses while participants complete a memory task
Measured: Baseline, Day 28
Change in behavior during fMRI task
Behavioral responses (episodic memory performance) will be recorded by an external button box. These responses will be used to assess encoding accuracy during an episodic memory task.
Measured: Baseline, Day 28
Secondary outcomes (3)
Change in brain morphology: gray matter volume
Using MRI, changes in gray matter volume will be analyzed from baseline (day 0) to day 28
Measured: Baseline, Day 28
Change in brain morphology: cortical thickness
Using MRI, changes in cortical thickness will be analyzed from baseline (day 0) to day 28
Measured: Baseline, Day 28
Change in brain morphology: diffusion
Using MRI, changes in diffusion based measures will be analyzed from baseline (day 0) to day 28
Measured: Baseline, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start21 Apr 2022
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Rabin, Douglas Mental Health University Institute
- Investigators
- Rachel Rabin, Ph. D., Principal investigator, Douglas Mental Health University Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445180
- Sponsor's protocol ID
- IUSMD-21-11
- Status last verified
- Sep 2026
- First submitted
- 18 May 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Contact the P.I.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Neural Correlates of Cognitive Function Associated With Cannabis Abstinence in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use
- ClinicalTrials.gov ID
- NCT05445180
- Acronym / sponsor ID
- IUSMD-21-11
- Conditions
- Psychotic Disorders, Cannabis Use Disorder, Cannabis Dependence, Cannabis Use, Schizophrenia; Psychosis, Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 6 Jul 2022 (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.
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.
Detailed description
Background/Importance: Cognitive impairment is well established in people with psychosis and is associated with cannabis use. Despite high rates of cannabis use among people with psychosis and the general population, cannabis' effects on cognition and the brain and their recovery remain unclear. Therefore, this study will investigate the neurobiological basis of changes in cognitive processes associated with cannabis abstinence in people with psychosis and non-psychiatric controls.
Aims: To examine the effects of 28-days of cannabis abstinence in psychosis patients with cannabis use and non-psychiatric controls with cannabis use on (i) brain activity (paired with a memory task); (ii) brain morphology; (iii) to determine if changes in memory following 28-days of abstinence correlate with changes in brain activity and/or morphology and (iv) to determine if baseline brain function and morphology can predict successful abstinence.
Methods: Seventy-four psychosis patients with cannabis use and 60 non-psychiatric controls with cannabis use will be randomized to: (1) contingency reinforcement where biochemically verified abstinence at day 28 will be rewarded; or (2) a non-abstinent control group. The investigators will also recruit a group of healthy non-psychiatric controls (n=40) to determine if neural outcomes in cannabis-using participants do indeed normalize ("recover") following abstinence. Participants will undergo structural and functional magnetic resonance imaging while completing a memory task at baseline (pre-abstinence) and following 28-days of abstinence. Urine samples will be collected twice weekly for abstinence verification.
Relevance: This study will help to characterize the neuropathophysiological processes underlying cognitive dysfunction associated with cannabis use in people with psychosis and non-psychiatric controls which may help to guide the development of novel neurobiologically-informed interventions to treat problematic cannabis use.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Psychosis patients with cannabis use (Abstinent) | Experimental | Behavioral: Contingency managementPsychosis patients with cannabis use will receive contingency management to encourage cannabis abstinence for 28 days |
| Psychosis patients with cannabis use (Non-abstinent) | No intervention | –Psychosis Patients with cannabis use who will continue to use cannabis as usual |
| Non-Psychiatric controls with cannabis use (Abstinent) | Experimental | Behavioral: Contingency managementNon-Psychiatric controls with cannabis use will receive contingency management to encourage cannabis abstinence for 28 days |
| Non-Psychiatric controls with cannabis use (Non-abstinent) | No intervention | –Non-Psychiatric Controls with cannabis use will continue to use cannabis as usual |
| Non-Psychiatric Controls without cannabis use | No intervention | –Non-Psychiatric controls without cannabis use |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Able to provide informed consent 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 arm only)
- Be an outpatient receiving a stable dose of medication(s) for at least two months (psychosis patient arm only)
Key exclusion criteria (9 listed)
- current SUD (other than CUD)
- MRI contraindications
- Positive urine screen for psychoactive substances other than cannabis, nicotine, or caffeine
- Current suicidal or homicidal ideation
- Head injury requiring hospitalization or loss of consciousness > 5 minutes
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 |
|---|---|---|
| Contingency managementContingency management will be used to encourage abstinence | Behavioural | Non-Psychiatric controls with cannabis use (Abstinent), Psychosis patients with cannabis use (Abstinent) |
Primary outcome
Change in fMRI brain activity pattern
Time frame: Baseline, Day 28
fMRI will be used to measure differences between baseline (day 0) and day 28 in hemodynamic (BOLD) responses while participants complete a memory task
Change in behavior during fMRI task
Time frame: Baseline, Day 28
Behavioral responses (episodic memory performance) will be recorded by an external button box. These responses will be used to assess encoding accuracy during an episodic memory task.
3 secondary outcomes
Change in brain morphology: gray matter volume
Time frame: Baseline, Day 28
Change in brain morphology: cortical thickness
Time frame: Baseline, Day 28
Change in brain morphology: diffusion
Time frame: Baseline, Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes. Contact the P.I.
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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.
Rachel Rabin, Ph. D. principal investigator
Douglas Mental Health University Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency management in people with Psychotic Disorders and Cannabis Use Disorder, run by Douglas Mental Health University Institute 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlene Osei-Afrifa ((514) 761-6131 ext. 3348, aimh.research@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fMRI brain activity pattern (time frame: Baseline, Day 28). The study lists 2 primary outcomes in all. 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 15 Sep 2026.