Cannabis for Alcoholism

Overseen By Jane Metrik, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Brown University

Disqualifiers: Pregnancy, Nursing, Other drugs, others

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

Compensation: Varies

Number of Visits: 4

350 Participants Needed

Trial Summary

What is the purpose of this trial?

This study employs a repeated measures experimental design to examine the effect of THC-dominant dose of cannabis and CBD-dominant dose of cannabis, relative to placebo, on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. Cannabis will be administered simultaneously with an alcohol-priming dose or alcohol placebo. The study will enroll up to 350 nontreatment-seeking heavy episodic alcohol drinkers who use cannabis weekly.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot participate if you test positive for drugs other than cannabis.

What data supports the effectiveness of the drug for alcoholism?

Preliminary research suggests that cannabidiol (CBD), a component of cannabis, may reduce alcohol consumption and protect against some harmful effects of alcohol, like liver and brain damage, in preclinical studies. However, human studies are limited and do not provide definitive conclusions about its effectiveness for alcohol use disorder. ^{1 2 3 4 5}

Is CBD-dominant cannabis safe for human use?

Preliminary studies suggest that CBD, a compound found in cannabis, may be safe for human use, as it has no abuse potential and may even protect against some harmful effects of alcohol. However, more research is needed to fully understand its safety profile, especially when used with alcohol. ^{1 2 3 6 7}

How does the drug cannabis differ from other treatments for alcoholism?

Cannabis, specifically the component cannabidiol (CBD), is being explored as a treatment for alcoholism because it may help reduce alcohol consumption, unlike traditional treatments that often focus on behavioral therapy or medications targeting alcohol cravings. CBD is unique because it is derived from the cannabis plant and has shown potential in preclinical studies to reduce alcohol dependence, although its exact effects in humans are still being studied. ^{1 2 8 9 10}

Research Team

Jane Metrik, PhD

Principal Investigator

Brown University

Eligibility Criteria

This trial is for people aged 21-50 who are heavy drinkers and have smoked cannabis weekly in the past two months. They must be under 250 lbs, not pregnant or nursing, and not currently seeking treatment to quit alcohol or cannabis use.

Inclusion Criteria

History of cannabis smoking in the past two months

Zero breath alcohol at each visit

English-speaking

Exclusion Criteria

Nursing

Interest to quit or receive treatment for cannabis or alcohol use

Positive pregnancy test

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants are tested at a baseline session to establish initial conditions

1 session

1 visit (in-person)

Experimental Sessions

Participants undergo three experimental sessions with cannabis and alcohol/placebo administration

3 sessions

3 visits (in-person)

Natural Environment Monitoring

Participants are monitored using a smartphone application for a 4-week period in their natural environment

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after the experimental sessions

4 weeks

Treatment Details

Interventions

• CBD-dominant cannabis
• THC-dominant cannabis

Trial Overview The study tests how THC-dominant and CBD-dominant cannabis doses affect participants' choice between drinking alcohol or receiving money as a reward for abstaining. It compares these effects with placebos in a controlled setting.

Participant Groups

Group I: THC-dominant cannabis dose Experimental Treatment 2 Interventions

367 mg of cannabis plant material with 9.53% THC and 0.09% CBD and 217 mg of placebo cannabis plant material will be mixed and smoked in a handheld pipe

Group II: CBD-dominant cannabis dose Experimental Treatment 2 Interventions

367 mg of cannabis plant material with 11.27% CBD and 0.35% THC and 217 mg of placebo cannabis plant material will be mixed and smoked in a handheld pipe

Group III: Alcohol priming dose Experimental Treatment 3 Interventions

Alcohol: 0.3 g/kg. Alcohol priming drink is designed to raise blood alcohol levels to 0.03 g/dl and be consumed in 5 minutes. The drink is mixed using 80-proof liquor and juice. Participants are randomized to receive either the experimental alcohol priming dose or alcohol placebo.

Group IV: Placebo Placebo Group 2 Interventions

584 mg of cannabis plant material will be smoked in a handheld pipe

Group V: Alcohol placebo dose Placebo Group 3 Interventions

Placebo beverage contains only juice and a negligible trace of alcohol for masking. The weight and sex-adjusted volume of alcohol and non-alcohol containing beverages will be equal. Participants are randomized to receive either the experimental alcohol priming dose or alcohol placebo.

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

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]

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]

Preliminary studies suggest that cannabidiol (CBD) may reduce alcohol consumption and protect against some harmful effects of alcohol, such as liver and brain damage, based on both preclinical and limited human research.

However, there is a lack of comprehensive studies on the interactions between CBD and alcohol in humans, making it difficult to draw definitive conclusions about their combined effects and potential therapeutic implications for alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cannabidiol on alcohol-related outcomes: A review of preclinical and human research. Nona, CN., Hendershot, CS., Le Foll, B.[2019]

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]

Reducing the number of days individuals use cannabis is linked to improvements in their overall functioning, suggesting that this could be a valuable outcome measure in treatment trials for cannabis use disorder (CUD).

While reductions in the amount of cannabis used showed inconsistent links to functional improvements, biologically-confirmed reductions in usage frequency may serve as a reliable endpoint for future clinical trials, highlighting the need for further research on quantifying cannabis reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Within-Individual Cannabis Reduction in Clinical Trials: A Review of the Methodological Challenges. Tomko, RL., Gray, KM., Huestis, MA., et al.[2022]

In a study with selectively bred Sardinian alcohol-preferring rats, CBD significantly reduced alcohol self-administration at doses of 12.5 mg/kg and higher, suggesting its potential to mitigate alcohol-motivated behaviors.

CBD did not affect the consumption of a palatable chocolate solution in Wistar rats, indicating that its effects may be specific to alcohol rather than general appetite suppression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Effect of Cannabidiol on Alcohol Self-Administration in Sardinian Alcohol-Preferring Rats. Maccioni, P., Bratzu, J., Carai, MAM., et al.[2023]

In a study involving 18 healthy adults, vaporized CBD and CBD-dominant cannabis produced noticeable subjective effects, such as increased enjoyment, while oral CBD did not show any significant effects compared to placebo.

Importantly, neither vaporized CBD nor CBD-dominant cannabis caused cognitive or psychomotor impairment, suggesting that these forms of CBD may be safer alternatives to THC-dominant products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacodynamic effects of vaporized and oral cannabidiol (CBD) and vaporized CBD-dominant cannabis in infrequent cannabis users. Spindle, TR., Cone, EJ., Goffi, E., et al.[2022]

From 1970 to 2017, the concentration of delta-9-tetrahydrocannabinol (THC) in cannabis has significantly increased, with an annual rise of 0.29% in herbal cannabis and 0.57% in cannabis resin, based on a review of 12 studies involving over 66,000 samples.

In contrast, the concentration of cannabidiol (CBD) remained stable over the same period, indicating that while THC levels are rising, the potential moderating effects of CBD on THC's impact may not be changing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) concentrations in cannabis over time: systematic review and meta-analysis. Freeman, TP., Craft, S., Wilson, J., et al.[2022]

In a survey of 533 cannabis users who drink alcohol, those using cannabis to treat a medical condition reported drinking less frequently than those who do not use cannabis for treatment.

The type of cannabis used affects alcohol consumption; individuals using high-THC/CBD cannabis tended to drink more on days they used cannabis compared to those using medium or low-THC/CBD cannabis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating Relationships Between Alcohol and Cannabis Use in an Online Survey of Cannabis Users: A Focus on Cannabinoid Content and Cannabis for Medical Purposes. Karoly, HC., Mueller, RL., Andrade, CC., et al.[2021]

In a study of 551 heavy drinkers, those who used cannabis reported more binge drinking days and higher scores on alcohol use disorder assessments, indicating a link between cannabis use and increased alcohol consumption.

Excluding cannabis users from alcohol use disorder research may limit the representativeness of study samples and overlook the clinical severity associated with co-use, suggesting that including these individuals could enhance the understanding of alcohol use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inclusion of Cannabis Users in Alcohol Research Samples: Screening In, Screening Out, and Implications. Venegas, A., Meredith, LR., Cooper, ZD., et al.[2023]

References

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

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

2. 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]

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

Effects of cannabidiol on alcohol-related outcomes: A review of preclinical and human research. [2019]

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

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

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

Measuring Within-Individual Cannabis Reduction in Clinical Trials: A Review of the Methodological Challenges. [2022]

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

Reducing Effect of Cannabidiol on Alcohol Self-Administration in Sardinian Alcohol-Preferring Rats. [2023]

7. Ireland pubmed.ncbi.nlm.nih.gov

Pharmacodynamic effects of vaporized and oral cannabidiol (CBD) and vaporized CBD-dominant cannabis in infrequent cannabis users. [2022]

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

Changes in delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) concentrations in cannabis over time: systematic review and meta-analysis. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Investigating Relationships Between Alcohol and Cannabis Use in an Online Survey of Cannabis Users: A Focus on Cannabinoid Content and Cannabis for Medical Purposes. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Inclusion of Cannabis Users in Alcohol Research Samples: Screening In, Screening Out, and Implications. [2023]