Ignite Creation Date:
2024-05-06 @ 12:55 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03883360
Status:
WITHDRAWN
Last Update Posted:
2021-04-19
First Post:
2019-03-14
Brief Title:
Effects of Cannabidiol on Psychiatric Symptoms Cognition and Cannabis Consumption in Cannabis Users With Recent-Onset Psychosis
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Effects of Cannabidiol on Psychiatric Symptoms Cognition and Cannabis Consumption in Cannabis Users With Recent-Onset Psychosis
Status:
WITHDRAWN
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
not funded
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A large proportion of people with a schizophrenia-spectrum disorder especially in the early stages of the disease regularly consume cannabis Cannabis use is associated with poor prognostic outcome however there are no effective interventions targeted at reducing cannabis use or its deleterious effects in this population The present trial is designed to test whether cannabidiol CBD a cannabinoid whose effects are in many ways antagonistic to those of Δ9-tetrahydrocannabinol THC can reduce psychiatric symptoms cognitive deficits and cannabis use in people with recent-onset psychosis who regularly consume cannabis
Detailed Description:
This is a double-blind randomized placebo-controlled trial evaluating the effects of a 12-week treatment course with CBD on psychiatric symptoms cognition and cannabis consumption in regular cannabis users with recent-onset psychosis The study will be conducted at the Maryland Psychiatric Research Center University of Maryland School of Medicine and associated Early Intervention Programs in Baltimore at the Sheppard Pratt Health System in Baltimore and at the Psychosis Clinic of the University of California Los Angeles
The daily dose of CBD is 600 mg po administered as adjunct medication Any non-exclusionary antipsychotic antidepressant anxiolytic or other medication prescribed prior to the trial will be continued Participants may but do not have to be taking conventional antipsychotic medication
The study will include 84 regular cannabis users with a schizophrenia-spectrum disorder who experienced their first psychotic episode within the last 5 years 90 Participants will be randomized 11 to either the CBD or the placebo group
Outcome measures include psychiatric symptoms cognition global functioning and drug use and will be assessed at baseline and every 3 or 6 weeks thereafter depending on the measure until the end of treatment at 12 weeks Outcome will be assessed again at a 3-month follow-up
The daily dose of CBD is 600 mg po administered as adjunct medication Any non-exclusionary antipsychotic antidepressant anxiolytic or other medication prescribed prior to the trial will be continued Participants may but do not have to be taking conventional antipsychotic medication
The study will include 84 regular cannabis users with a schizophrenia-spectrum disorder who experienced their first psychotic episode within the last 5 years 90 Participants will be randomized 11 to either the CBD or the placebo group
Outcome measures include psychiatric symptoms cognition global functioning and drug use and will be assessed at baseline and every 3 or 6 weeks thereafter depending on the measure until the end of treatment at 12 weeks Outcome will be assessed again at a 3-month follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None