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

Sponsor
Douglas Mental Health University Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05445180
Collaborator
(none)
134
1
5
60.3
2.2

Study Details

Study Description

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
  • Behavioral: Contingency management
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 21, 2022
Anticipated Primary Completion Date :
May 1, 2027
Anticipated Study Completion Date :
May 1, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in fMRI brain activity pattern [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 [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 [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 [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 [Baseline, Day 28]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Douglas Mental Health University Institute Montréal Quebec Canada H4H 1R3

Sponsors and Collaborators

  • Douglas Mental Health University Institute

Investigators

  • Principal Investigator: Rachel Rabin, Ph. D., Douglas Mental Health University Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rachel Rabin, Assistant Professor, Douglas Mental Health University Institute
ClinicalTrials.gov Identifier:
NCT05445180
Other Study ID Numbers:
  • IUSMD-21-11
First Posted:
Jul 6, 2022
Last Update Posted:
Jul 6, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2022