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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether different types of cannabis can help reduce alcohol consumption in individuals who frequently drink heavily. Researchers are testing two cannabis types—one high in THC (THC-dominant cannabis) and the other high in CBD (CBD-dominant cannabis)—against a placebo to observe their effects on drinking behavior. Participants might smoke cannabis and then choose between having a drink or earning money for abstaining. This trial suits individuals who have been heavy drinkers and cannabis users in the past two months and are not seeking treatment for alcohol or cannabis use. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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.

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

Research has shown that THC, the main active ingredient in cannabis, can safely alleviate nausea and vomiting from chemotherapy. One study found that THC concentrates can increase feelings of intoxication, but these effects are usually manageable.

CBD, another key component of cannabis, is generally considered safe and typically does not cause impairment. Some research suggests that CBD might help reduce cravings and stress related to alcohol use. However, mixing CBD with other medications or alcohol is best avoided due to possible interactions.

Extensive studies on both THC and CBD indicate they can be used safely in controlled settings. However, like any treatment, some individuals might experience side effects. These findings are important to consider when deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using CBD-dominant and THC-dominant cannabis for treating alcoholism because these treatments offer a novel approach compared to traditional methods like behavioral therapy and medications such as naltrexone or acamprosate. Unlike these existing options, which primarily target cravings and withdrawal symptoms, cannabis components like CBD and THC may interact with the endocannabinoid system, potentially altering the brain's response to alcohol cues and reward pathways. This could help reduce alcohol cravings and consumption in a new way. Additionally, smoking cannabis in a controlled dose provides a unique method of delivery that could offer rapid effects.

What evidence suggests that this trial's treatments could be effective for alcoholism?

Research has shown that CBD-dominant cannabis, one of the treatments in this trial, can help reduce alcohol cravings and manage stress. In studies, participants using CBD drank less and had fewer days of alcohol use. Conversely, THC-dominant cannabis, another treatment option in this trial, has mixed effects. Some research suggests that high-THC products might lead to increased drinking on days when cannabis is used. However, both CBD and THC can improve mood, which might aid in managing alcohol use. Overall, CBD appears more effective than THC in reducing alcohol intake. ^{1 3 6 7 8}

Who Is on the Research Team?

Jane Metrik, PhD

Principal Investigator

Brown University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8855954/

Patterns of Cannabis and Alcohol Co-Use: Substitution Versus ... Results of this review reveal compelling evidence for both substitution and complementary effects, suggesting nuanced yet significant distinctions across ...

2. nature.com nature.com/articles/s41380-024-02869-y

Acute cannabidiol administration reduces alcohol craving ... CBD is effective in targeting AUD symptoms and disease processes that drive alcohol use and relapse, due to its anti-craving, stress-reducing, and anti- ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2451865424000887

The neurobehavioural effects of cannabidiol in alcohol use ... Preclinical research has demonstrated that CBD administration reduces stress and drug cue alcohol reinstatement, voluntary alcohol consumption, withdrawal ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05389930

NCT05389930 | Cannabis' Impact on Alcohol Consumption This study employs a repeated measures experimental design to examine the effect of THC-dominant (9.53% THC and 0.09% CBD) dose of cannabis and CBD-dominant ( ...

5. researchgate.net researchgate.net/publication/350394637_THC_and_CBD_effects_on_alcohol_use_among_alcohol_and_cannabis_co-users

THC and CBD Effects on Alcohol Use Among ... The CBD group drank fewer drinks per drinking day (p < .05), had fewer alcohol use days (p < .05), and fewer alcohol and cannabis co-use days (p ...

6. library.samhsa.gov library.samhsa.gov/sites/default/files/pep22-06-04-003.pdf

Cannabidiol (CBD) – Potential Harms, Side Effects, and ... Do not use CBD concurrently with medications, alcohol, or illicit drugs. ... CBD-dominant cannabis administration. Journal of Analytical Toxicology, 46(5) ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0953620521001527

“Is medical cannabis safe for my patients?” A practical ... The utility of CBD-dominant products may improve safe cannabis initiation as it is considered non-impairing.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11393281/

Clinical Benefits and Safety of Medical Cannabis Products Australian registry data show that use of CBD-predominant products (approximately 2:1 ratio for CBD and ∆9-THC dosing) results in small sustained ...