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

Trial Summary

What is the purpose of this trial?

This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum CBD and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with alcohol use disorder. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.

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.

What evidence supports the effectiveness of the drug Cannabidiol (CBD) for treating alcohol use disorder?

Research in mice shows that CBD can reduce alcohol consumption, motivation to drink, and relapse, suggesting it might help with alcohol use disorder. Additionally, a systematic review indicates that CBD has potential benefits in reducing alcohol-related harms and addiction behaviors in preclinical models, although more human studies are needed to confirm these effects. ^{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 profile. ^{3 4 5 6 7}

How is the drug Cannabidiol (CBD) unique in treating alcohol use disorder?

Cannabidiol (CBD) is unique because it is a nonpsychoactive component of cannabis that has shown promise in reducing alcohol consumption and related harms in preclinical models, without the risk of abuse. Unlike traditional treatments, CBD may offer neuroprotective benefits and reduce alcohol-induced liver damage, but more human studies are needed to confirm these effects. ^{3 4 5 7 8}

Research Team

Kent Hutchison, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

I am 21 years old or older.

Exclusion Criteria

I use CBD products for health reasons.

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

Lack of access to internet

Timeline

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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 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 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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. Switzerland pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

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

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

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

5. Ireland pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Cannabidiol as a candidate pharmacotherapy for sleep disturbance in alcohol use disorder. [2023]

7. 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]

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

THC and CBD effects on alcohol use among alcohol and cannabis co-users. [2021]