Cannabidiol for Alcoholism

Overseen By Elise M Weerts, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Johns Hopkins University

Must not be taking: Gabapentin, Benzodiazepines, Sedative-hypnotics, others

Disqualifiers: Cirrhosis, Cannabis use, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether cannabidiol (CBD), a compound found in cannabis, can ease withdrawal symptoms and reduce cravings in people with alcohol use disorder (AUD). Participants will stay at Johns Hopkins Hospital for five days, receiving either CBD or a placebo while abstaining from alcohol. The trial will monitor CBD's effects on symptoms like anxiety and sleep problems commonly seen during alcohol withdrawal. Individuals who consume at least eight drinks a day and have experienced significant withdrawal symptoms before might be a good fit for this trial. As a Phase 2, Phase 3 trial, this research measures CBD's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop taking my current medications to join the trial?

Yes, you will need to stop taking certain medications. Specifically, you cannot use gabapentin, benzodiazepines, or other sedative-hypnotic medications within the week before joining the trial. Additionally, you cannot use any prescription medication that might interfere with the study, as determined by the investigator.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CBD is generally safe for people. In studies, participants tolerated CBD well, and it did not interact negatively with alcohol. Compared to other addiction treatments, CBD is safer and has fewer side effects. Some studies suggest that CBD can help reduce cravings and symptoms of alcohol use disorder. Overall, evidence indicates that CBD could be a safe option for managing alcohol withdrawal symptoms. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alcoholism?

Unlike traditional treatments for alcoholism, which often involve medications like disulfiram, naltrexone, or acamprosate, cannabidiol (CBD) offers a new approach by potentially targeting the brain's endocannabinoid system. Researchers are excited about CBD because it is derived from cannabis and might help manage alcohol cravings and withdrawal symptoms without the intoxicating effects associated with marijuana. The trial explores both low and high doses of CBD, which could provide insights into the most effective dosing strategy. This cannabinoid-based treatment could represent a shift towards more natural, plant-based therapies for alcoholism, offering hope for those seeking alternative options.

What evidence suggests that cannabidiol might be an effective treatment for alcoholism?

Research has shown that cannabidiol (CBD) might help people with alcohol use disorder (AUD). Some studies suggest that CBD can lessen cravings and withdrawal symptoms in those with AUD. Observations in humans indicate that using CBD is linked to reduced alcohol consumption and does not increase mental impairment when used with alcohol. In this trial, participants will receive either a high dose (20 mg/kg) or a low dose (10 mg/kg) of CBD, or a placebo. A previous trial found that CBD reduced cravings and symptoms of AUD compared to a placebo. Additionally, studies in animals have shown that CBD can help with symptoms like anxiety and seizures, which often occur during alcohol withdrawal. ^{1 2 3 4 5}

Who Is on the Research Team?

David Woliinsky, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults with moderate-to-severe alcohol use disorder (AUD) who experience symptoms like anxiety, sleep problems, and seizures during withdrawal. Participants will stay in a hospital for 5 days to manage withdrawal. They must not have other conditions that could interfere with the study or be unsafe.

Inclusion Criteria

Drinking at least 8 drinks a day over the two weeks prior to screening

Shipley vocabulary score > 18, corresponding to 5th grade reading level

I understand the study details and can agree to participate.

Exclusion Criteria

Systolic blood pressure (SBP) > 180, Diastolic Blood Pressure (DBP) > 120, or pulse > 120 during screening or upon admission

Regular use of benzodiazepines (twice a week or more) within the last three months

Meet DSM-5 criteria for moderate-to-severe substance use disorder (SUD), including Cannabis Use Disorder (except for alcohol and tobacco)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Treatment

Participants are admitted for a 5-day, 4-night stay to manage alcohol withdrawal with CBD or placebo

5 days

Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol

Trial Overview The trial tests if Cannabidiol (CBD), a compound found in cannabis, can help reduce alcohol withdrawal symptoms and cravings compared to a placebo. It's randomized and controlled: some get CBD while others get an inactive substance without knowing which one they receive.

How Is the Trial Designed?

Group I: 20 mg/kg CBD Active Control 1 Intervention

high dose CBD

Group II: 10 mg/kg CBD Active Control 1 Intervention

low dose CBD

Group III: placebo Placebo Group 1 Intervention

Placebo (no CBD)

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2451865424000887

The neurobehavioural effects of cannabidiol in alcohol use ... Preclinical and clinical results suggest that CBD might be particularly well suited for the treatment of AUD and may reduce alcohol cue and stress-induced ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6910215/

CANNABIDIOL AS A NOVEL CANDIDATE ALCOHOL USE ... Another preclinical study illustrated that combined CBD and naltrexone was more effective at reducing alcohol consumption than CBD or naltrexone alone (Viudez- ...

3. nature.com nature.com/articles/s41386-025-02164-6

Cannabidiol mitigates alcohol dependence and withdrawal ... Observational data in humans link CBD to reduced alcohol use [76, 77] and co-administration with alcohol shows no worsened cognitive impairment ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05613608

NCT05613608 | Alcohol Use Disorder and Cannabidiol This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of fsCBD and bsCBD, compared to a placebo control, to reduce ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1516351/full

A preliminary randomized trial of the safety, tolerability, and ... In this pilot study, safety profiles fsCBD and bsCBD were similar, and fsCBD was associated with a greater reduction in craving and AUD symptoms relative to ...