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

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ClinicalTrials.gov Identifier: NCT05445180
Recruitment Status : Recruiting
First Posted : July 6, 2022
Last Update Posted : July 6, 2022
Sponsor:
Information provided by (Responsible Party):
Rachel Rabin, Douglas Mental Health University Institute

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Psychotic Disorders Cannabis Use Disorder Cannabis Dependence Cannabis Use Schizophrenia; Psychosis Cognitive Dysfunction Memory Impairment Neuroimaging Behavioral: Contingency management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Research Assistant
Primary Purpose: Basic Science
Official Title: Investigating the Neural Correlates of Cognitive Function Associated With Cannabis Abstinence in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use
Actual Study Start Date : April 21, 2022
Estimated Primary Completion Date : May 2027
Estimated Study Completion Date : May 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Psychosis patients with cannabis use (Abstinent)
Psychosis patients with cannabis use will receive contingency management to encourage cannabis abstinence for 28 days
Behavioral: Contingency management
Contingency management will be used to encourage abstinence

No Intervention: Psychosis patients with cannabis use (Non-abstinent)
Psychosis Patients with cannabis use who will continue to use cannabis as usual
Experimental: Non-Psychiatric controls with cannabis use (Abstinent)
Non-Psychiatric controls with cannabis use will receive contingency management to encourage cannabis abstinence for 28 days
Behavioral: Contingency management
Contingency management will be used to encourage abstinence

No Intervention: Non-Psychiatric controls with cannabis use (Non-abstinent)
Non-Psychiatric Controls with cannabis use will continue to use cannabis as usual
No Intervention: Non-Psychiatric Controls without cannabis use
Non-Psychiatric controls without cannabis use



Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Change in brain morphology: gray matter volume [ Time Frame: Baseline, Day 28 ]
    Using MRI, changes in gray matter volume will be analyzed from baseline (day 0) to day 28

  2. Change in brain morphology: cortical thickness [ Time Frame: Baseline, Day 28 ]
    Using MRI, changes in cortical thickness will be analyzed from baseline (day 0) to day 28

  3. Change in brain morphology: diffusion [ Time Frame: Baseline, Day 28 ]
    Using MRI, changes in diffusion based measures will be analyzed from baseline (day 0) to day 28



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • Being pregnant
  • DSM-5 Axis 1 diagnosis (other than CUD) (non-psychiatric controls only)
  • Taking psychotropic medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05445180


Contacts
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Contact: Charlene Osei-Afrifa (514) 761-6131 ext 3348 aimh.research@gmail.com

Locations
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Canada, Quebec
Douglas Mental Health University Institute Recruiting
Montréal, Quebec, Canada, H4H 1R3
Contact: Research Coordinator    (514) 761-6131 ext 3348    aimh.research@gmail.com   
Principal Investigator: Rachel Rabin, Ph. D.         
Sponsors and Collaborators
Douglas Mental Health University Institute
Investigators
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Principal Investigator: Rachel Rabin, Ph. D. Douglas Mental Health University Institute
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Responsible Party: Rachel Rabin, Assistant Professor, Douglas Mental Health University Institute
ClinicalTrials.gov Identifier: NCT05445180    
Other Study ID Numbers: IUSMD-21-11
First Posted: July 6, 2022    Key Record Dates
Last Update Posted: July 6, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Contact the P.I.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Access Criteria: Contact the P.I.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Marijuana Abuse
Schizophrenia
Psychotic Disorders
Mental Disorders
Cognitive Dysfunction
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Cognition Disorders
Neurocognitive Disorders