Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:18 PM
Study NCT ID:
NCT07279558
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cannabidiol and Alcohol Use Disorder Phenotypes
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Effects of Full-spectrum Cannabidiol on Alcohol Consumption and Alcohol Use Disorder Phenotypes: Implications for Precision Medicine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
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:
CAP
Brief Summary:
The goal of this clinical trial is to compare the effects of Full-Spectrum CBD (CBD containing a small amount of THC), Broad-Spectrum CBD (CBD with no THC), and placebo on alcohol consumption and clinically relevant Alcohol Use Disorder (AUD) phenotypes among adults with AUD. The main questions it aims to answer are:
* Does Full-Spectrum CBD (fs-CBD), compared to Broad-Spectrum CBD (bs-CBD) and placebo, reduce participant alcohol consumption?
* Does Full-Spectrum CBD (fs-CBD), compared to Broad-Spectrum CBD (bs-CBD) and placebo, reduce negative emotionality and other AUD phenotypes?
* What are the effects of fs-CBD and bs-CBD on the gut microbiome and gut permeability?
Researchers will compare fs-CBD to bs-CBD and a placebo (a look-alike substance that contains no CBD or THC) to see if fs-CBD reduces participant alcohol consumption.
Participation will last 12 weeks during which participants will:
* Take the randomly assigned study drug (fs-CBD, bs-CBD, or placebo) daily for 8 weeks and report alcohol use via daily surveys
* Attend 5 in-person study visits
* Check in virtually with study staff weekly during the 8-week medication period
* Does Full-Spectrum CBD (fs-CBD), compared to Broad-Spectrum CBD (bs-CBD) and placebo, reduce participant alcohol consumption?
* Does Full-Spectrum CBD (fs-CBD), compared to Broad-Spectrum CBD (bs-CBD) and placebo, reduce negative emotionality and other AUD phenotypes?
* What are the effects of fs-CBD and bs-CBD on the gut microbiome and gut permeability?
Researchers will compare fs-CBD to bs-CBD and a placebo (a look-alike substance that contains no CBD or THC) to see if fs-CBD reduces participant alcohol consumption.
Participation will last 12 weeks during which participants will:
* Take the randomly assigned study drug (fs-CBD, bs-CBD, or placebo) daily for 8 weeks and report alcohol use via daily surveys
* Attend 5 in-person study visits
* Check in virtually with study staff weekly during the 8-week medication period
Detailed Description:
This project is a randomized, placebo-controlled trial comparing the effects of Full-Spectrum CBD (\[fs-CBD\] CBD with \< .03% THC) relative to Broad-Spectrum CBD (\[bs-CBD\] CBD that does not contain THC) and placebo, on alcohol consumption (in the lab and in the real world \[Aim 1\]) and on several clinically relevant Alcohol Use Disorder (AUD) phenotypes (Aims 2 and 3), among adults with AUD. Specifically, this trial will test the effects of fs-CBD (vs. bs-CBD and placebo) on self-reported alcohol intake over a 12-week period, alcohol self-administered during a session in our bar lab, and an alcohol biomarker in the blood over the course of the 12-week study. Investigators will also test the effects of fs-CBD (vs. bs-CBD and placebo) on a battery of AUD phenotyping measures (corresponding to the Addictions Neuroclinical Assessment \[ANA\] domains) that could aid in identifying individuals for whom fs-CBD is likely to be an effective treatment (Aim 2) and on the gut microbiome (Exploratory Aim 3), which has been shown to play an important role in the etiology and maintenance of AUD. Investigators will recruit adults with AUD to be randomly assigned to take 200 mg of fs-CBD, bs-CBD, or placebo daily for 8 weeks. During this 8-week period, participants will report alcohol use via daily surveys and have weekly, virtual check-ins with study staff. Subjects will attend five in-person study sessions, provide two home-collected fecal samples for assaying the gut microbiome, and have blood drawn several times to measure CBC, CMP, PEth, gut permeability, and blood cannabinoid levels throughout the study. At the end of the 8-week study medication period, participants will attend a lab session involving an alcohol self-administration (bar lab) task, ANA assessments, and a blood draw (to measure an alcohol biomarker and circulating gut markers). The ANA battery and blood and fecal samples will also be collected prior to starting study medication, so that post-intervention change in the proposed mediators can be measured. Study participation will span 12 weeks.
Study Oversight
Has Oversight DMC:
True
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 |
|---|---|---|---|---|
| R01AA031664 | NIH | None | https://reporter.nih.gov/quic… | View |