Cannabidiol for Alcoholism

Overseen By Kelly Xiao, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Centre for Addiction and Mental Health

Must not be taking: Anticraving medications, CBD products

Disqualifiers: Severe mental illness, seizures, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether cannabidiol (CBD), a compound from cannabis, can reduce drinking and alcohol cravings in people with alcohol use disorder (AUD). Participants will take both CBD and a placebo (a harmless pill with no active ingredient) over two different periods to assess their effects on alcohol consumption. Suitable candidates are those who drink more than 10 standard drinks a week for women or 15 for men, have AUD, and are willing to take the study medication and attend lab sessions where they consume alcohol. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does exclude those with prescriptions or over-the-counter medications that interfere with the study drug or alcohol. It's best to discuss your specific medications with the study physician.

Is there any evidence suggesting that cannabidiol is likely to be safe for humans?

Research has shown that cannabidiol (CBD) is generally safe for people. In past studies, participants using CBD experienced safety outcomes similar to those using other types of CBD, indicating that the treatment did not cause more side effects than expected. Additionally, when combined with alcohol, CBD did not increase thinking or memory problems beyond those caused by alcohol alone. These findings suggest that CBD might be a safe option for people with alcohol use disorder. While no treatment is without risk, evidence supports that CBD is relatively safe for human use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for alcoholism, which often include medications like naltrexone or acamprosate that work by reducing cravings or managing withdrawal symptoms, cannabidiol (CBD) offers a fresh approach. CBD is derived from cannabis plants and is believed to interact with the body’s endocannabinoid system, which could help in reducing alcohol-seeking behavior and cravings. Researchers are excited about CBD because it has a different mechanism of action and might provide benefits without the same level of side effects associated with some current medications. Additionally, CBD is known for its calming effects, which could be beneficial in managing anxiety and stress related to alcohol withdrawal. This makes CBD a promising candidate for those seeking alternative options in treating alcoholism.

What evidence suggests that cannabidiol might be an effective treatment for alcohol use disorder?

This trial will compare Cannabidiol (CBD) with a placebo to evaluate its effects on alcohol use disorder. Research has shown that CBD might help individuals with alcohol use disorder drink less and experience fewer cravings. Studies have found that CBD use correlates with reduced alcohol consumption. Some research suggests that CBD could manage alcohol dependence and withdrawal symptoms without worsening cognitive issues. Additionally, CBD may reduce cravings triggered by alcohol-related cues and stress, making it a promising treatment option. These findings suggest that CBD could help individuals drink less and feel fewer urges to drink. ^{4 5 6 7 8}

Who Is on the Research Team?

Matthew Sloan, MD

Principal Investigator

Centre for Addiction and Mental Health

Are You a Good Fit for This Trial?

This trial is for individuals with alcohol use disorder who are interested in testing a new treatment. Participants must meet certain health criteria to join, but specific inclusion and exclusion details were not provided.

Inclusion Criteria

Agrees not to use cannabis or illicit drugs during the study period

I have been drinking more than the recommended amount weekly for the past 3 months.

ALT and AST levels should not be more than 2 times the upper normal limit, and bilirubin should not be more than 1.5 times the upper normal limit

Exclusion Criteria

Recent recreational drug use (assessed via urine toxicology screen) other than alcohol and nicotine products

Clinical Institute Withdrawal Assessment (CIWA-Ar) score of 10 or above upon initial assessment

Currently institutionalized which refers to a person who lives in an institutional collective dwelling, such as a hospital, nursing home or prison, including a resident under custody (e.g., patient or inmate)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive 600mg of cannabidiol or placebo daily for 10 consecutive days

10 days

Daily visits for medication administration

Washout

A 2-week washout period between treatment phases

2 weeks

Treatment Phase 2

Participants receive the alternate treatment (cannabidiol or placebo) daily for 10 consecutive days

10 days

Daily visits for medication administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol

Trial Overview

The study is testing the effects of an oral solution of cannabidiol (CBD) on reducing alcohol craving and consumption compared to a placebo. It's set up so each participant will try both CBD and the placebo at different times, with a break in between.

How Is the Trial Designed?

Group I: Cannabidiol Experimental Treatment 1 Intervention

10-day supply of 600 mg of CBD, taken orally twice daily

Group II: Placebo Placebo Group 1 Intervention

10-day supply of 600 mg of placebo, taken orally twice daily

Cannabidiol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in Canada as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Published Research Related to This Trial

Cannabidiol (CBD) shows promise as a potential treatment for alcohol use disorder (AUD), demonstrating neuroprotective effects and reducing alcohol-related harms in rodent models, including decreased alcohol self-administration and withdrawal symptoms.

In human studies, CBD was well tolerated and did not affect the subjective experience of alcohol, suggesting it may be a safe option for further investigation in treating AUD, although more human clinical trials are needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol as a Novel Candidate Alcohol Use Disorder Pharmacotherapy: A Systematic Review. Turna, J., Syan, SK., Frey, BN., et al.[2020]

In a placebo-controlled study with 36 heavy-drinking participants, CBD showed minimal effects on breath alcohol levels (BrAC) and subjective feelings related to alcohol consumption, suggesting it does not significantly alter alcohol's impact in humans.

While CBD appeared to slow the decrease in stimulation and sedation effects compared to placebo, the differences were trivial, indicating that more research is needed to understand CBD's potential role in alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consuming oral cannabidiol prior to a standard alcohol dose has minimal effect on breath alcohol level and subjective effects of alcohol. Karoly, HC., Drennan, ML., Prince, MA., et al.[2023]

Cannabidiol (CBD) has shown promise in reducing alcohol consumption and related behaviors in animal models of alcohol use disorder (AUD), suggesting it could help lower drinking levels and prevent relapse.

CBD may also protect the liver and brain from alcohol-related damage by reducing fat accumulation in the liver, modulating inflammation, and preventing neuronal loss, indicating potential benefits for individuals with AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Prospects of Cannabidiol for Alcohol Use Disorder and Alcohol-Related Damages on the Liver and the Brain. De Ternay, J., Naassila, M., Nourredine, M., et al.[2023]

The combination of low doses of naltrexone and cannabidiol (CBD) significantly reduced alcohol consumption and motivation to drink in mice more effectively than either drug alone, suggesting a synergistic effect.

This enhanced efficacy is linked to changes in gene expression related to opioid and serotonin receptors, particularly the 5-HT1A receptor, indicating that these receptors play a crucial role in the mechanism of action for the drug combination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cannabidiol plus naltrexone on motivation and ethanol consumption. Viudez-Martínez, A., García-Gutiérrez, MS., Fraguas-Sánchez, AI., et al.[2021]

In a study involving seven male baboons with a history of daily alcohol intake, neither acute nor chronic treatment with cannabidiol (CBD) significantly reduced alcohol seeking or consumption behaviors, indicating that CBD may not be effective for treating alcohol use disorder.

Despite administering CBD doses within the therapeutic range, there were no changes in drinking patterns or observable side effects, suggesting that pure CBD does not disrupt normal behavior in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Cannabidiol does not alter Alcohol Seeking and Self-Administration in Baboons. Moore, CF., Zamarripa, CA., Weerts, EM.[2023]

In a study with C57BL/6 J mice, cannabidiol (CBD) significantly reduced ethanol consumption and preference, indicating its potential effectiveness in decreasing alcohol intake.

CBD also decreased motivation for ethanol and reduced relapse rates, suggesting it may be a promising treatment for alcohol use disorders by altering gene expression related to reward pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol reduces ethanol consumption, motivation and relapse in mice. Viudez-Martínez, A., García-Gutiérrez, MS., Navarrón, CM., et al.[2019]

A systematic review of 51 clinical studies indicates that cannabidiol (CBD) is generally well tolerated in humans, with most adverse events (AEs) being mild to moderate, such as diarrhea and sedation.

While serious AEs are rare, they can occur, particularly when CBD is taken with other medications, highlighting the need for careful monitoring of drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on Cannabidiol Clinical Toxicity and Adverse Effects: A Systematic Review. Madeo, G., Kapoor, A., Giorgetti, R., et al.[2023]

A review of 207 studies identified only 3 randomized clinical trials (RCTs) specifically focused on using cannabidiol (CBD) for cannabis use disorder, highlighting a significant gap in research for CBD's efficacy in treating substance use disorders.

Ongoing trials are enhancing outcome measures by incorporating peripheral biomarkers from the endocannabinoid system, which may help predict how well individuals respond to CBD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Trials of Cannabidiol for Substance Use Disorders: Outcome Measures, Surrogate Endpoints, and Biomarkers. Morel, A., Lebard, P., Dereux, A., et al.[2021]

Citations

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sciencedirect.com

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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 ...

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

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Jennifer Attonito, PhD Florida Atlantic University - CCORC

Men drank more weekly than women (21.54 vs. 16.61 drinks; SD = 11.5, 10.89) and were more likely to use CBD for alcohol dependence (59.7% vs. 45.5%). Among ...

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pubmed.ncbi.nlm.nih.gov

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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 ...

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frontiersin.org

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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 ...

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A preliminary randomized trial of the safety, tolerability, and ...

It was hypothesized that both CBD conditions would be well tolerated and would reduce drinking, alcohol dependence, and craving compared to ...