Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569394
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
A Study of Cannabidiol in Young Adult Cannabis Users
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Placebo Controlled Study of Cannabidiol in Young Adult Cannabis Users
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We will study the harm-reducing effect of hemp-derived CBD in non-treatment-seeking emerging adults who use cannabis regularly The study will use our novel naturalistic cannabis administration approach which examines ecologically valid cannabis use utilizing a mobile lab setting to assess the effects of the cannabis products the participants regularly use We will recruit a sample of emerging adults half of whom primarily use flower products and half of whom primarily use concentrate products Individuals will be randomly assigned to hemp-derived CBD or placebo
Detailed Description:
Emerging adults have the highest prevalence of cannabis use and CUD of any age group Despite high rates of use and CUD treatment seeking is relatively uncommon among emerging adults Those who use cannabis are less confident in their ability to abstain and show higher rates of ambivalence regarding the goal of abstinence than those who use other drugs Thus emerging adult cannabis users may be more receptive to non-abstinence or harm reduction approaches The overarching aim of this proposal is to assess the effects of hemp-derived CBD in emerging adults on harms associated with cannabis use including subjective intoxication affect and mood psychotic experiences and cognitive functioning as well as to examine whether CBD supplementation reduces self-administration of THC and symptoms of CUD We propose a study design with high external validity and experimental controls to study the harm-reducing effect of hemp-derived CBD in non-treatment-seeking emerging adults who use cannabis regularly The study will use our novel naturalistic cannabis administration approach which examines ecologically valid cannabis use utilizing a mobile lab setting to assess the effects of the cannabis products the participants regularly use We will recruit a sample of emerging adults half of whom primarily use flower products and half of whom primarily use concentrate products Individuals will be randomly assigned to hemp-derived CBD or placebo consistent with our preliminary studies that have approved US Food and Drug Administration FDA Investigation New Drug IND 153535 and 157515
The specific aims are to
Aim 1 Test whether assignment to hemp-derived CBD relative to placebo over 8 weeks is associated with a reduced self-administration of THC b a reduction in CUD symptoms c lower levels of anxiety depression d better cognitive function and e higher anandamide AEA levels Hypothesis Compared to baseline the CBD group will demonstrate reduced THC administration fewer CUD symptoms lower levels of anxiety and depression and better cognitive functioning at 4 and 8 weeks compared to the placebo group At 12 weeks 4 weeks post-trial these effects will persist Assignment to CBD will be correlated with higher AEA levels
Aim 2 Test whether assignment to hemp-derived CBD relative to placebo reduces acute effects of cannabis administration on a subjective drug effects b cognitive function and c mood and psychotic symptoms Hypothesis Compared to cannabis self-administration at baseline without CBD the CBD group will demonstrate lower subjective drug effects mood elevation anxiety fewer psychotic symptoms and better cognitive functioning after cannabis self-administration at 4 and 8 weeks compared to the placebo group At 12 weeks 4 weeks post-trial these effects will persist
Aim 3 Test whether cannabis product type flower vs concentrates moderates the association between CBD assignment and a cannabis use b mood and anxiety and c cognitive functioning in both longer-term aim 1 and acute aim 2 effects Hypothesis CBD effects will be greater among those who use concentrates compared to those who use flower products for both longer-term and acute effects
The specific aims are to
Aim 1 Test whether assignment to hemp-derived CBD relative to placebo over 8 weeks is associated with a reduced self-administration of THC b a reduction in CUD symptoms c lower levels of anxiety depression d better cognitive function and e higher anandamide AEA levels Hypothesis Compared to baseline the CBD group will demonstrate reduced THC administration fewer CUD symptoms lower levels of anxiety and depression and better cognitive functioning at 4 and 8 weeks compared to the placebo group At 12 weeks 4 weeks post-trial these effects will persist Assignment to CBD will be correlated with higher AEA levels
Aim 2 Test whether assignment to hemp-derived CBD relative to placebo reduces acute effects of cannabis administration on a subjective drug effects b cognitive function and c mood and psychotic symptoms Hypothesis Compared to cannabis self-administration at baseline without CBD the CBD group will demonstrate lower subjective drug effects mood elevation anxiety fewer psychotic symptoms and better cognitive functioning after cannabis self-administration at 4 and 8 weeks compared to the placebo group At 12 weeks 4 weeks post-trial these effects will persist
Aim 3 Test whether cannabis product type flower vs concentrates moderates the association between CBD assignment and a cannabis use b mood and anxiety and c cognitive functioning in both longer-term aim 1 and acute aim 2 effects Hypothesis CBD effects will be greater among those who use concentrates compared to those who use flower products for both longer-term and acute effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None