NCT05445180 Investigating the Neural Correlates of Cognitive Function in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use
| NCT ID | NCT05445180 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Douglas Mental Health University Institute |
| Condition | Psychotic Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2022-04-21 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 134 participants in total. It began in 2022-04-21 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Rachel Rabin, Ph. D.
PRINCIPAL INVESTIGATOR
Douglas Mental Health University Institute
Frequently Asked Questions
Who can join the NCT05445180 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 80 Years, studying Psychotic Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05445180 currently recruiting?
Yes, NCT05445180 is actively recruiting participants. Contact the research team at aimh.research@gmail.com for enrollment information.
Where is the NCT05445180 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05445180 clinical trial?
NCT05445180 is sponsored by Douglas Mental Health University Institute. The principal investigator is Rachel Rabin, Ph. D. at Douglas Mental Health University Institute. The trial plans to enroll 134 participants.