What side effects are associated with this type of intervention?

Common treatments for cannabis intoxication and use disorder include medications like gabapentin, varenicline, and nabiximols. Gabapentin can cause side effects such as headache, insomnia, and mood changes. Varenicline may lead to nausea, sleep disturbances, and abnormal dreams. Nabiximols, a cannabis extract, can cause dizziness, dry mouth, and fatigue. When combined with ethanol, cannabinoids can enhance motor impairments and cognitive deficits, potentially leading to significant decrements in performance and increased blood ethanol concentrations.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for cannabis intoxication. However, pharmacologic management with THC (such as dronabinol and nabiximols) is suggested for moderate to severe cannabis withdrawal symptoms. Additionally, benzodiazepines like lorazepam or midazolam are recommended for managing dystonia in synthetic cannabinoid intoxication. These treatments aim to alleviate symptoms rather than directly counteract intoxication.

What other types of research exist?

For cannabis intoxication, promising alternatives to cannabinoids and ethanol include the use of benzodiazepines for managing symptoms like dystonia. Additionally, addressing acute kidney injury with appropriate renal management and consulting a nephrologist for related complications is recommended. These approaches focus on symptom management and supportive care rather than using substances that affect the central nervous system.

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Alcohol

Cannabis + Alcohol on Impairment

Phase 1

Recruiting

Led By Tory Spindle, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between the ages of 21 and 50

Be between the ages of 21 and 55

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7.5 hours

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical reactions to cannabis such as altered perception, dizziness, dry mouth, red eyes; and for alcohol: impaired coordination, slurred speech, nausea. The combination might intensify these effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 21 and 50 years old.

Select...

I am between 21 and 55 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7.5 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7.5 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7.5 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biphasic alcohol effects scale (BAES) - Sedative Score

Biphasic alcohol effects scale (BAES) - Stimulant Score

Correct Trials on Paced Auditory Serial Addition Task (PASAT)

+10 more

Secondary study objectives

Attempted Trials on the Digit Symbol Substitution Task (DSST)

Driving performance (distance to lead vehicles)

Driving performance (mean speed)

+16 more

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: low dose cannabis with placebo alcoholExperimental Treatment2 Interventions

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

Group II: low dose cannabis with low dose alcoholExperimental Treatment2 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 alcoholExperimental Treatment2 Interventions

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

Group IV: high dose cannabis with low dose alcoholExperimental Treatment2 Interventions

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

Group V: Placebo cannabis + low dose alcoholExperimental Treatment2 Interventions

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

Group VI: Placebo cannabis + high dose alcoholExperimental Treatment2 Interventions

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

Group VII: Placebo cannabis + placebo alcoholPlacebo Group2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cannabis

2014

Completed Phase 3

~780

Alcohol

2008

Completed Phase 3

~1360

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for cannabis intoxication include topiramate, varenicline, nabiximols, and cannabidiol. Topiramate, an antiepileptic agent, modulates neurotransmitter receptors and ion channels, potentially reducing cannabis use but with notable side effects. Varenicline, a nicotinic acetylcholine receptor agonist, shows promise in increasing abstinence rates by modulating the reward pathways. Nabiximols, a cannabinoid-based medication, and cannabidiol, a major cannabinoid constituent, both interact with the endocannabinoid system to reduce cannabis use and withdrawal symptoms. These treatments are crucial for cannabis intoxication patients as they target the central nervous system, helping to manage dependence and improve abstinence rates, which is particularly relevant when considering the combined effects of cannabinoids and ethanol on cognitive and motor functions.

Ethanol and delta9-tetrahydrocannabinol interactive effects on human perceptual, cognitive and motor functions. II.Effects of two cannabinoids upon abstinence signs in ethanol-dependent mice.The interaction of ethanol and delta9-tetrahydrocannabinol in man: effects on perceptual, cognitive and motor functions.