Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-31 @ 3:56 PM
Study NCT ID:
NCT06569394
Status:
RECRUITING
Last Update Posted:
2025-02-07
First Post:
2024-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Cannabidiol in Young Adult Cannabis Users
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
A Randomized, Placebo Controlled Study of Cannabidiol in Young Adult Cannabis Users
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators will study the harm-reducing effect of hemp-derived CBD in non-treatment-seeking emerging adults who use cannabis regularly. The study will use a 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. The investigators 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. The investigators 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 a 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. The investigators 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 the 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:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1P50DA056408 | NIH | None | https://reporter.nih.gov/quic… | View |