Cannabis + Alcohol on Impairment

Overseen by Tory Spindle, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Johns Hopkins University

Must not be taking: Psychoactive drugs, OTC drugs

Disqualifiers: Significant medical condition, Psychiatric condition, Severe alcohol use, others

Trial Summary

What is the purpose of this trial?

This trial tests how taking cannabis pills and drinking alcohol together affect people's behavior and abilities. It involves adults taking different amounts of cannabis and alcohol to see how these combinations impact tasks like driving and thinking clearly.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using certain drugs or medications that could affect safety. It's best to discuss your specific medications with the trial staff.

What evidence supports the effectiveness of the drug Cannabis and Alcohol for impairment?

Research suggests that CBD, a component of cannabis, may help reduce alcohol consumption and protect against some harmful effects of alcohol, like liver and brain damage. However, combining alcohol with CBD does not significantly change the effects of alcohol on motor and mental performance. ^{1 2 3 4 5}

Is it safe to use cannabis and alcohol together?

Research suggests that using cannabis and alcohol together can increase impairment and the risk of accidents. While CBD (a compound in cannabis) might reduce some harmful effects of alcohol, the combination of THC (another compound in cannabis) and alcohol can lead to significant intoxication and unwanted side effects. More studies are needed to fully understand the safety of using these substances together. ^{3 4 5 6 7}

How does the drug Cannabis + Alcohol differ from other treatments for impairment?

This study is unique because it explores the effects of combining cannabis concentrates, which are high in THC, with alcohol, and examines how the order of use (cannabis before alcohol or vice versa) affects intoxication. Unlike other treatments, this research focuses on the acute effects of co-use, which is understudied, and aims to provide insights for harm-reduction strategies. ^{2 3 4 8 9}

Research Team

Tory Spindle, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

Participants must be healthy adults aged 21-55, not pregnant or nursing, with a BMI of 19-36 kg/m2. They should have engaged in binge drinking at least twice in the past 90 days and used cannabis within the last year but no more than twice weekly over the past three months.

Inclusion Criteria

I have not donated blood in the last 30 days.

I am between 21 and 50 years old.

Have a body mass index (BMI) in the range of 19 to 36 kg/m2

Exclusion Criteria

Been in treatment previously for alcohol or cannabis use disorder

Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month

I am not taking any medications or supplements that could affect my safety in the trial.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete 7 outpatient drug administration sessions with self-administration of oral cannabis and alcohol

7 sessions

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Alcohol (Alcohol)
• Cannabis (Cannabinoid)

Trial Overview The study is examining how oral cannabis and alcohol affect people's subjective feelings of impairment and their actual performance on tasks. It will look at these substances both separately and together to understand their combined effects.

Participant Groups

Group I: low dose cannabis with placebo alcohol Experimental Treatment 2 Interventions

Participants administer oral cannabis containing 10mg THC in combination with a placebo alcohol drink.

Group II: low dose cannabis with low dose alcohol Experimental Treatment 2 Interventions

Participants administer oral cannabis containing 10mg THC in combination with an alcohol drink (0.05 percent BAC).

Group III: high dose cannabis with placebo alcohol Experimental Treatment 2 Interventions

Participants administer oral cannabis containing 25mg THC in combination with a placebo alcohol drink.

Group IV: high dose cannabis with low dose alcohol Experimental Treatment 2 Interventions

Participants administer oral cannabis containing 25mg THC in combination with an alcohol drink (0.05 percent BAC).

Group V: Placebo cannabis + low dose alcohol Experimental Treatment 2 Interventions

Participants administer oral cannabis containing 0mg THC in combination with an alcohol drink (0.05 percent BAC).

Group VI: Placebo cannabis + high dose alcohol Experimental Treatment 2 Interventions

Participants administer oral cannabis containing 0mg THC in combination with an alcohol drink (0.08 percent BAC).

Group VII: Placebo cannabis + placebo alcohol Placebo Group 2 Interventions

Participants administer oral cannabis containing 0mg THC in combination with a placebo alcohol drink.

Alcohol is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Ethanol for:

• None (not approved as a therapeutic agent)

Approved in Japan as Ethanol for:

• None (not approved as a therapeutic agent)

Approved in China as Ethanol for:

• None (not approved as a therapeutic agent)

Approved in Switzerland as Ethanol for:

• None (not approved as a therapeutic agent)

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

Findings from Research

In a study involving 10 healthy volunteers, CBD alone did not impair motor or psychomotor performance, while alcohol significantly did, indicating that CBD may not negatively affect cognitive functions on its own.

When combined with alcohol, CBD resulted in lower blood alcohol levels compared to alcohol alone, suggesting that CBD may mitigate some effects of alcohol, although the overall impairments in performance remained similar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interaction of cannabidiol and alcohol in humans. Consroe, P., Carlini, EA., Zwicker, AP., et al.[2019]

In a study of injured drivers presenting to emergency departments in cannabis-legal states, 8% reported cannabis use within 8 hours before a motor vehicle collision (MVC), but biosample testing revealed a higher prevalence of 18%.

High-risk crash features were prevalent among drivers using cannabis, whether alone or with alcohol; however, seriously injured patients were less likely to report cannabis use compared to alcohol use, indicating potential differences in the impact of these substances on crash severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis presentations to the emergency department after MVC in the era of legalization for recreational use. Choo, EK., Nishijima, D., Trent, S., 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]

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]

A significant portion of cannabis products (58.5%) lacked information on CBD content, and most products (72-100%) with CBD fell into the highly intoxicating THC:CBD ratio category (≥1:1), suggesting that patients may experience enhanced acute effects and intoxication.

Medical and recreational cannabis products are largely similar, posing a risk for patients seeking therapeutic benefits, as they may inadvertently consume high-potency products that lead to unwanted side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potency and Therapeutic THC and CBD Ratios: U.S. Cannabis Markets Overshoot. Pennypacker, SD., Cunnane, K., Cash, MC., et al.[2022]

In a study of 465,090 U.S. individuals aged 12 to 25, less frequent cannabis use (1-20 days/month) was significantly linked to higher rates of alcohol dependence and various alcohol-related problems, indicating that even occasional cannabis users may be at risk for alcohol use disorders.

The research suggests that both frequent and less frequent cannabis use are associated with serious alcohol-related issues, such as heavy drinking and risky behaviors, highlighting the need for careful consideration of cannabis use in alcohol treatment and policy planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency of cannabis use and alcohol-associated adverse effects in a representative sample of U.S. adolescents and youth (2002-2014) a cross-sectional study. Ramadan, MM., Banta, JE., Bahjri, K., et al.[2021]

The study of 589 drivers showed that while blood THC concentration is related to specific physical signs like conjunctival injection and pupil dilation, it does not correlate with most clinical tests for impairment.

When THC and ethanol are present together, the risk of being judged impaired significantly increases, indicating that their combined effects on driving ability are greater than either substance alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impairment due to cannabis and ethanol: clinical signs and additive effects. Bramness, JG., Khiabani, HZ., Mørland, J.[2019]

In a study with alcohol-preferring rats, combining ethanol and THC significantly impaired memory in an object recognition task, highlighting the risks of co-abusing these substances.

The memory impairment was linked to the activation of CB1 receptors, as a specific antagonist reversed the effects of THC, indicating a potential mechanism for the observed synergistic action between ethanol and THC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memory impairment following combined exposure to delta(9)-tetrahydrocannabinol and ethanol in rats. Ciccocioppo, R., Antonelli, L., Biondini, M., et al.[2019]

This study aims to investigate the acute effects of co-using cannabis concentrates and alcohol, focusing on how the cannabinoid content and the order of consumption (cannabis before alcohol vs. alcohol before cannabis) influence intoxication levels.

By using a mobile laboratory to measure both objective (like blood cannabinoid levels and psychomotor performance) and subjective intoxication, the research seeks to provide clearer insights that could inform harm-reduction strategies for individuals who use both substances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a mobile laboratory study of co-administration of cannabis concentrates with a standard alcohol dose in humans. Karoly, HC., Prince, MA., Emery, NN., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Interaction of cannabidiol and alcohol in humans. [2019]

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

Cannabis presentations to the emergency department after MVC in the era of legalization for recreational use. [2022]

3. 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]

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

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

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

Potency and Therapeutic THC and CBD Ratios: U.S. Cannabis Markets Overshoot. [2022]

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

Frequency of cannabis use and alcohol-associated adverse effects in a representative sample of U.S. adolescents and youth (2002-2014) a cross-sectional study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Impairment due to cannabis and ethanol: clinical signs and additive effects. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Memory impairment following combined exposure to delta(9)-tetrahydrocannabinol and ethanol in rats. [2019]

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

Protocol for a mobile laboratory study of co-administration of cannabis concentrates with a standard alcohol dose in humans. [2022]