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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05445180
Other study ID # IUSMD-21-11
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 21, 2022
Est. completion date May 2027

Study information

Verified date May 2024
Source Douglas Mental Health University Institute
Contact Charlene Osei-Afrifa
Phone (514) 761-6131
Email aimh.research@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 134
Est. completion date May 2027
Est. primary completion date May 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 80 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Contingency management
Contingency management will be used to encourage abstinence

Locations

Country Name City State
Canada Douglas Mental Health University Institute Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Douglas Mental Health University Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Change in brain morphology: gray matter volume Using MRI, changes in gray matter volume will be analyzed from baseline (day 0) to day 28 Baseline, Day 28
Secondary Change in brain morphology: cortical thickness Using MRI, changes in cortical thickness will be analyzed from baseline (day 0) to day 28 Baseline, Day 28
Secondary Change in brain morphology: diffusion Using MRI, changes in diffusion based measures will be analyzed from baseline (day 0) to day 28 Baseline, Day 28
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