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

NCT05445180 | Recruiting

• 1 other identifier: IUSMD-21-11
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorders; Cannabis Use Disorder; Cannabis Dependence; Cannabis Use; Schizophrenia; Psychosis; Cognitive Dysfunction; Memory Impairment; Neuroimaging

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Baseline, Day 28

Secondary Outcomes (3)

• Change in brain morphology: gray matter volume

  Baseline, Day 28

• Change in brain morphology: cortical thickness

  Baseline, Day 28

• Change in brain morphology: diffusion

  Baseline, Day 28

Study Arms (5)

Psychosis patients with cannabis use (Abstinent)

EXPERIMENTAL

Psychosis patients with cannabis use will receive contingency management to encourage cannabis abstinence for 28 days

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

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

Interventions

Contingency management BEHAVIORAL

Contingency management will be used to encourage abstinence

Non-Psychiatric controls with cannabis use (Abstinent); Psychosis patients with cannabis use (Abstinent)

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Douglas Mental Health University Institute: lead

Study Sites (1)

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Marijuana Abuse; Schizophrenia; Cognitive Dysfunction; Memory Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Cognition Disorders; Neurocognitive Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rachel Rabin, Ph. D.

  Douglas Mental Health University Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlene Osei-Afrifa

CONTACT

(514) 761-6131; aimh.research@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research Assistant
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: July 6, 2022
• Study Start: April 21, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Access Criteria: Contact the P.I.

Locations

CA (1)