Alcohol Use Disorder study: Cannabidiol
Official title Alcohol Use Disorder and Cannabidiol
ClinicalTrials.gov ID: NCT05613608
What this study is testing
What is Cannabidiol?
This is an investigational medicine being studied to see if it can help reduce alcohol use in people with alcohol use disorder. is designed to interact with the body's endocannabinoid system, which helps regulate mood, stress, and inflammation.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study wants to find out if two types of CBD oil help people with alcohol use disorder reduce their drinking compared to a fake treatment.
- Who it's for
- The study is looking for people who have alcohol use disorder.
- What's involved
- Participants will take a daily dose of either full-spectrum CBD, broad-spectrum CBD, or a placebo (a pill with no active medicine) for 12 weeks.
- Time commitment
- The study lasts 12 weeks, and participants will need to take their assigned treatment daily.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Must be ≥21 years old.
- Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current Alcohol Use Disorder (AUD) of at least moderate...
- Expresses desire to reduce or quit drinking.
- If male, reports drinking, on average, at least 15 standard alcoholic drinks per week prior to screening
- Able to attend in-person visits at the study site.
You likely can't join if
- Self-reported DSM-V diagnosis of any other substance use disorder.
- Self-report illicit/recreational use of cocaine, methamphetamines, amphetamines, MDMA, opioids, or benzodiazepines in the last 30 days.
- Uses CBD products for medical reasons.
- Self-reports or indicates having a serious DSM-V psychiatric disorder, including panic disorder, obsessive/compulsive disorder, post-traumatic stress...
- Endorsing item 2 on the C-SSRS measure of suicide risk.
- Those known to have a major interaction with Epidiolex.
See the full eligibility criteria
- Must be ≥21 years old.
- Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current Alcohol Use Disorder (AUD) of at least moderate severity (i.e., 4 or more DSM-V symptoms).
- Expresses desire to reduce or quit drinking.
- If male, reports drinking, on average, at least 15 standard alcoholic drinks per week prior to screening
- Able to attend in-person visits at the study site.
- Participants reporting current nicotine use in any form will be included.
- Self-reported DSM-V diagnosis of any other substance use disorder.
- Self-report illicit/recreational use of cocaine, methamphetamines, amphetamines, MDMA, opioids, or benzodiazepines in the last 30 days.
- Uses CBD products for medical reasons.
- Self-reports or indicates having a serious DSM-V psychiatric disorder, including panic disorder, obsessive/compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, cluster B...
- Endorsing item 2 on the C-SSRS measure of suicide risk.
- Those known to have a major interaction with Epidiolex.
- Acute treatment with any antiepileptic medications.
- Medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, and/or topiramate).
- Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens).
- Clinically significant medical problems in the last six months, such as cardiovascular, renal, gastrointestinal, or endocrine problems, that would impair participation or limit medication ingestion.
- Current or past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer.
- Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
- Current charges pending for a violent crime (not including DUI-related offenses).
- Lack of a stable living situation.
- Lack of access to internet.
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.