Investigating the Neural Correlates of Cognitive Function in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use
NCT ID: NCT05445180
Last Updated: 2024-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
134 participants
INTERVENTIONAL
2022-04-21
2027-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Psychosis patients with cannabis use (Abstinent)
Psychosis patients with cannabis use will receive contingency management to encourage cannabis abstinence for 28 days
Contingency management
Contingency management will be used to encourage abstinence
Psychosis patients with cannabis use (Non-abstinent)
Psychosis Patients with cannabis use who will continue to use cannabis as usual
No interventions assigned to this group
Non-Psychiatric controls with cannabis use (Abstinent)
Non-Psychiatric controls with cannabis use will receive contingency management to encourage cannabis abstinence for 28 days
Contingency management
Contingency management will be used to encourage abstinence
Non-Psychiatric controls with cannabis use (Non-abstinent)
Non-Psychiatric Controls with cannabis use will continue to use cannabis as usual
No interventions assigned to this group
Non-Psychiatric Controls without cannabis use
Non-Psychiatric controls without cannabis use
No interventions assigned to this group
Interventions
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Contingency management
Contingency management will be used to encourage abstinence
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
* Being pregnant
* DSM-5 Axis 1 diagnosis (other than CUD) (non-psychiatric controls only)
* Taking psychotropic medication
16 Years
80 Years
ALL
Yes
Sponsors
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Douglas Mental Health University Institute
OTHER
Responsible Party
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Rachel Rabin
Assistant Professor
Principal Investigators
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Rachel Rabin, Ph. D.
Role: PRINCIPAL_INVESTIGATOR
Douglas Mental Health University Institute
Locations
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Douglas Mental Health University Institute
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IUSMD-21-11
Identifier Type: -
Identifier Source: org_study_id
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