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

ConditionsPsychotic DisordersCannabis Use DisorderCannabis DependenceCannabis UseSchizophrenia; PsychosisCognitive DysfunctionMemory ImpairmentNeuroimaging
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-80
SponsorDouglas Mental Health University Institute

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

current SUD (other than CUD)

MRI contraindications

Positive urine screen for psychoactive substances other than cannabis, nicotine, or caffeine

Current suicidal or homicidal ideation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Contingency management

    Behavioral

    Contingency management will be used to encourage abstinence

Treatment groups

134 Participants
are divided into 5 treatment groups
Group A: Psychosis patients with cannabis use (Abstinent)Experimental treatment 1 intervention
Group B: Psychosis patients with cannabis use (Non-abstinent)No intervention 0 interventions
Group C: Non-Psychiatric controls with cannabis use (Abstinent)Experimental treatment 1 intervention
Group D: Non-Psychiatric controls with cannabis use (Non-abstinent)No intervention 0 interventions
Group E: Non-Psychiatric Controls without cannabis useNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline, Day 28
2

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.

Time frame
Baseline, Day 28

Secondary outcomes

1

Change in brain morphology: gray matter volume

Using MRI, changes in gray matter volume will be analyzed from baseline (day 0) to day 28

Time frame
Baseline, Day 28
2

Change in brain morphology: cortical thickness

Using MRI, changes in cortical thickness will be analyzed from baseline (day 0) to day 28

Time frame
Baseline, Day 28
3

Change in brain morphology: diffusion

Using MRI, changes in diffusion based measures will be analyzed from baseline (day 0) to day 28

Time frame
Baseline, Day 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Douglas Mental Health University Institute

Lead sponsor

Source ClinicalTrials.gov
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