Cannabidiol for Alcohol Use Disorder

Overseen By Jaime Laurin, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Colorado, Denver

Must not be taking: Antiepileptics, Alcohol medications

Disqualifiers: Substance use disorder, Daily cannabis, Psychiatric disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether cannabidiol (CBD) can help people with alcohol use disorder reduce their drinking. Participants will receive either full-spectrum CBD, broad-spectrum CBD, or a placebo for 12 weeks to determine which is most effective in reducing alcohol intake. The study seeks individuals who wish to cut down on drinking and currently consume an average of at least 15 drinks per week for men or 10 drinks per week for women. As a Phase 2 trial, this research measures CBD's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to important findings.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they interact with Epidiolex, are antiepileptic, or affect alcohol intake, like disulfiram, naltrexone, acamprosate, or topiramate.

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

Research has shown that both full-spectrum and broad-spectrum CBD are generally safe for use. In a small study, both types of CBD demonstrated similar safety results, with no major safety issues or severe side effects reported. This suggests that these forms of CBD are likely safe for most people.

Full-spectrum CBD contains a tiny amount of THC (less than 0.3%), while broad-spectrum CBD has no THC. Studies have found that neither type causes significant negative effects. Additionally, research suggests that both types can help reduce alcohol cravings in people with alcohol use disorder.

While these findings are encouraging, it's important to remember that individual reactions to CBD can vary. Those considering joining a trial should consult a healthcare provider about any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using cannabidiol (CBD) for Alcohol Use Disorder because it offers a natural alternative to traditional treatments like naltrexone or acamprosate, which primarily target neurotransmitter systems. Unlike these medications, CBD is derived from the cannabis plant and works through the endocannabinoid system, potentially reducing cravings and anxiety without the psychoactive effects of THC. The trial explores both full-spectrum CBD, which contains a trace amount of THC, and broad-spectrum CBD, which is THC-free, to evaluate their effectiveness and safety. This novel approach could provide a new option for people seeking help with alcohol dependency without the side effects associated with existing drugs.

What evidence suggests that this trial's treatments could be effective for alcohol use disorder?

Research has shown that cannabidiol (CBD) might help reduce symptoms of alcohol use disorder (AUD). In this trial, participants will receive either full-spectrum CBD, broad-spectrum CBD, or a placebo. Studies have found that full-spectrum CBD can lower alcohol cravings and ease AUD symptoms more effectively than some other treatments. For broad-spectrum CBD, early research suggests it can decrease alcohol intake and reduce the urge to seek alcohol. Both types of CBD have been linked to reducing stress related to alcohol. Initial findings suggest these CBD options may help manage AUD, offering a promising choice for those looking to cut down on alcohol. ^{1 4 6 7 8}

Who Is on the Research Team?

Kent Hutchison, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults over 21 with moderate to severe Alcohol Use Disorder who drink heavily and want to cut down or stop. They must be able to visit the study site, not use cannabis daily, have no serious psychiatric disorders or recent medical issues, and not take certain medications that affect alcohol intake.

Inclusion Criteria

I want to cut down or stop drinking alcohol.

Participants reporting current nicotine use in any form will be included

Meets DSM-V criteria for current Alcohol Use Disorder (AUD) of at least moderate severity

Exclusion Criteria

I use CBD products for health reasons.

Endorsing item 2 on the C-SSRS measure of suicide risk

Current or past alcohol-related medical illness

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either full spectrum CBD, broad spectrum CBD, or placebo for 12 weeks to assess efficacy in reducing alcohol consumption and related symptoms

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol
• Placebo

Trial Overview

The study tests full spectrum CBD and broad spectrum CBD against a placebo in reducing alcohol consumption over 12 weeks. Participants are randomly assigned one of these options without knowing which one they receive (double-blind).

How Is the Trial Designed?

Group I: Full-Spectrum Cannabidiol Active Control 1 Intervention

210mg/day of full-spectrum cannabidiol, containing less than 0.3% THC.

Group II: Broad-Spectrum Cannabidiol Active Control 1 Intervention

210mg/day of full-spectrum cannabidiol, containing 0.0% THC.

Group III: Placebo Placebo Group 1 Intervention

210mg/day of hemp seed oil with no cannabinoids present.

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?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

In a study of 120 adults, those using cannabis with predominantly CBD consumed significantly fewer alcoholic drinks and had fewer drinking days compared to those using cannabis with predominantly THC or a combination of CBD and THC.

These results suggest that CBD may help reduce alcohol consumption, supporting previous preclinical findings and highlighting the importance of cannabinoid content in understanding alcohol and cannabis co-use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

THC and CBD effects on alcohol use among alcohol and cannabis co-users. Karoly, HC., Mueller, RL., Andrade, CC., et al.[2021]

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]

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) shows promise as a potential treatment for sleep disturbances in individuals with alcohol use disorder (AUD), as it may help restore the normal sleep-wake cycle and improve sleep quality.

Existing medications for AUD-related sleep issues often have significant side effects and abuse potential, making CBD's favorable safety profile an attractive alternative that warrants further investigation through well-designed randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol as a candidate pharmacotherapy for sleep disturbance in alcohol use disorder. Gendy, MNS., Frey, BN., Van Ameringen, M., et al.[2023]

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]

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]

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]

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This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum cannabidiol (CBD) and broad spectrum CBD, ...