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

Trial Summary

What is the purpose of this trial?

This human laboratory study aims to assess the effects of cannabidiol on alcohol consumption and craving in participants with alcohol use disorder. In this double-blind within-subject placebo-controlled crossover trial, participants will be randomized to receive both cannabidiol and placebo with a 2-week washout period separating the two treatment phases.

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.

What data supports the effectiveness of the drug Cannabidiol (CBD) for alcoholism?

Research in mice shows that CBD can reduce alcohol consumption, motivation to drink, and relapse, suggesting it might be useful for treating alcohol use disorders. ^{1 2 3 4 5}

Is cannabidiol (CBD) safe for humans?

Research suggests that cannabidiol (CBD) is generally well tolerated in humans, with no significant interactions with alcohol's effects and no abuse potential. However, more human studies are needed to confirm its safety and effectiveness. ^{1 4 6 7 8}

How is the drug Cannabidiol (CBD) unique in treating alcoholism?

Cannabidiol (CBD) is unique in treating alcoholism because it may reduce alcohol consumption, motivation, and relapse without the risk of abuse, and it also offers potential protective effects against alcohol-related liver and brain damage, which is not commonly addressed by other treatments. ^{1 3 4 6 8}

Research Team

Matthew Sloan, MD

Principal Investigator

Centre for Addiction and Mental Health

Eligibility Criteria

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

I do not have any severe liver problems or other serious unstable conditions.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Oral Cannabidiol does not alter Alcohol Seeking and Self-Administration in Baboons. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effects of cannabidiol plus naltrexone on motivation and ethanol consumption. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol reduces ethanol consumption, motivation and relapse in mice. [2019]

4. Germany 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. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Trials of Cannabidiol for Substance Use Disorders: Outcome Measures, Surrogate Endpoints, and Biomarkers. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Therapeutic Prospects of Cannabidiol for Alcohol Use Disorder and Alcohol-Related Damages on the Liver and the Brain. [2023]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Update on Cannabidiol Clinical Toxicity and Adverse Effects: A Systematic Review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Cannabidiol as a Novel Candidate Alcohol Use Disorder Pharmacotherapy: A Systematic Review. [2020]