THC for Alcohol Consumption

Overseen By Elnaz Nourollahimoghadam

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Colorado, Denver

Disqualifiers: Mri contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 2 sessions, separated by 7-14 days

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how high doses of THC, a compound in cannabis, affect alcohol use. Researchers aim to determine if THC influences the sense of reward from drinking and alters drinking habits. Participants will receive either THC (dronabinol, a form of THC) or a placebo (a pill with no active ingredient) in varying sequences. The trial seeks individuals who regularly consume both alcohol and cannabis. Those with metal implants or weighing over 315 pounds may not qualify. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant 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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that dronabinol, a synthetic version of THC, is usually safe for patients. The FDA has approved dronabinol for other uses, such as alleviating nausea in cancer patients and increasing appetite in people with AIDS. This approval indicates that its safety is well-understood for these purposes.

However, individuals with a history of substance abuse, such as marijuana or alcohol, might be more prone to misuse dronabinol. Therefore, it is crucial to consider this potential concern for anyone thinking about joining the study.

Overall, dronabinol's safety is supported by its use in other medical treatments, but high doses have not been widely studied with alcohol. Participants should consider this when deciding whether to join the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using dronabinol for reducing alcohol consumption because it introduces a novel approach by utilizing THC, the active component in cannabis. Unlike traditional treatments for alcohol use disorder, such as naltrexone or acamprosate, which focus on reducing cravings or stabilizing brain chemistry, dronabinol acts on the endocannabinoid system. This could potentially offer a new pathway for managing alcohol intake, particularly for those who haven't found success with existing medications. By targeting different receptors in the brain, dronabinol may provide a fresh hope for individuals struggling with alcohol dependency.

What evidence suggests that dronabinol might be an effective treatment for alcohol consumption?

Research shows that the link between cannabis use and alcohol consumption is complicated. Some studies have found that starting medical cannabis, such as dronabinol (a type of THC), can lead to reduced alcohol use for many people. For example, one study found that about 44% of participants reported drinking less often after starting cannabis. This trial will explore the effects of dronabinol on alcohol consumption, with one group receiving dronabinol first and placebo second, and the other group receiving placebo first and dronabinol second. This suggests that dronabinol might help change drinking habits. However, while there is potential, the exact effects of high doses of THC on alcohol use remain unclear. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who regularly drink alcohol and use cannabis. Participants should reach out to the study site for more detailed eligibility requirements.

Inclusion Criteria

I consume alcohol.

I use cannabis.

I need to contact the study site for more information.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Participants undergo a baseline session to establish initial conditions

1 day

1 visit (in-person)

Treatment

Participants receive either placebo or 20mg dronabinol and undergo MRI and alcohol consumption assessment

2 sessions, separated by 7-14 days

2 visits (in-person)

Follow-up

Participants are monitored for self-reported cannabis and alcohol use

14 days

Daily self-reports

What Are the Treatments Tested in This Trial?

Interventions

• Dronabinol

Trial Overview The study investigates how a high dose of oral THC (20mg dronabinol pill) versus a placebo affects brain reward systems, alcohol consumption, and real-world patterns of using both substances together.

How Is the Trial Designed?

Group I: Placebo first, Dronabinol second Experimental Treatment 2 Interventions

This arm will receive placebo on the first visit, and dronabinol on the second visit

Group II: Dronabinol first, Placebo second Experimental Treatment 2 Interventions

This arm will receive dronabinol on the first visit, and placebo on the second visit.

Dronabinol is already approved in United States, Canada for the following indications:

Approved in United States as Marinol for:

• HIV/AIDS-induced anorexia
• Chemotherapy-induced nausea and vomiting
• Sleep apnea

Approved in United States as Syndros for:

• HIV/AIDS-induced anorexia
• Chemotherapy-induced nausea and vomiting

Approved in Canada as REDUVO for:

• HIV/AIDS-induced anorexia
• Chemotherapy-induced nausea and vomiting

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Colorado State University

Collaborator

Trials

138

Recruited

38,200+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Two pediatric patients were admitted to the intensive care unit after unintentionally ingesting delta-8 THC products that resembled candy, highlighting the risks associated with these products for children.

While both patients experienced bradypnea and agitation, they were treated with supportive care and discharged after approximately 45 hours, indicating that while delta-8 THC can cause significant symptoms, timely medical intervention can lead to recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unintentional ingestion of putative delta-8 tetrahydrocannabinol by two youth requiring critical care: a case report. Bradley, EK., Hoots, BE., Bradley, ES., et al.[2023]

In a study involving nine female patients with chronic anorexia nervosa, low doses of oral Δ9-THC (1 mg/day for one week and 2 mg/day for three weeks) led to significant improvements in psychological symptoms such as body care, sense of ineffectiveness, asceticism, and depression.

While Δ9-THC showed promise in alleviating psychological symptoms associated with anorexia nervosa, it did not result in significant changes in body mass index (BMI), indicating that its effects may be more focused on mental health rather than physical weight gain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Δ9-THC on the Psychological Symptoms of Anorexia Nervosa: A Pilot Study. Avraham, Y., Latzer, Y., Hasid, D., et al.[2021]

Chronic administration of Δ(9)-THC did not significantly affect the progression of SIV infection in male Chinese-derived rhesus macaques, as there were no notable differences in viral loads compared to the placebo group.

Long-term Δ(9)-THC treatment was associated with a significant reduction in circulating IgE(+)B cells, suggesting potential immunomodulatory effects, but it did not enhance the pathogenicity of the SIV infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Δ(9)-Tetrahydrocannabinol Administration Reduces IgE(+)B Cells but Unlikely Enhances Pathogenic SIVmac251 Infection in Male Rhesus Macaques of Chinese Origin. Wei, Q., Liu, L., Cong, Z., et al.[2018]

A survey of delta-8-THC consumers revealed that over half (51%) use it to treat various health conditions, with anxiety and stress being the most common, suggesting potential therapeutic benefits.

Participants reported favorably comparing delta-8-THC to delta-9-THC and pharmaceutical drugs, indicating it may have similar efficacy with potentially fewer adverse effects, although knowledge about safe dosages and medical integration remains low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer Experiences with Delta-8-THC: Medical Use, Pharmaceutical Substitution, and Comparisons with Delta-9-THC. Kruger, DJ., Kruger, JS.[2023]

In a study involving 10 experienced marijuana smokers, oral Delta-9-tetrahydrocannabinol (Delta(9)-THC) was found to be chosen more often than a placebo, indicating some reinforcing effects, although participants selected it less than 50% of the time.

Both doses of Delta(9)-THC (10 mg and 20 mg) led to significant increases in positive subjective effects, impaired psychomotor performance, and increased heart rate, suggesting potential safety concerns alongside its therapeutic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reinforcing effects of oral Delta9-THC in male marijuana smokers in a laboratory choice procedure. Hart, CL., Haney, M., Vosburg, SK., et al.[2022]

Nabilone and dronabinol are effective treatments for chemotherapy-induced nausea and vomiting (CINV) in cancer patients who do not respond well to standard antiemetic therapies.

These cannabinoids work by targeting CB1 and CB2 receptors in the body, which may also provide additional benefits beyond just relieving nausea and vomiting, as suggested by preclinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The emerging role of cannabinoid neuromodulators in symptom management. Davis, M., Maida, V., Daeninck, P., et al.[2023]

In a study involving 30 patients on opioids for chronic pain, dronabinol (synthetic THC) was found to significantly reduce pain intensity and increase treatment satisfaction compared to a placebo, indicating its potential as an effective adjuvant treatment.

The extended Phase II trial showed that titrated doses of dronabinol provided significant pain relief and reduced pain bothersomeness, although side effects were dose-related, suggesting careful monitoring is needed when using this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of dronabinol as an adjuvant treatment for chronic pain patients on opioid therapy. Narang, S., Gibson, D., Wasan, AD., et al.[2013]

In a 12-week trial involving 156 cannabis-dependent adults, dronabinol (a synthetic form of THC) did not significantly increase the rate of abstinence compared to placebo, with both groups showing similar reductions in marijuana use.

However, dronabinol improved treatment retention (77% vs. 61% for placebo) and resulted in fewer withdrawal symptoms, suggesting it may be a well-tolerated option for supporting individuals in cannabis dependence treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dronabinol for the treatment of cannabis dependence: a randomized, double-blind, placebo-controlled trial. Levin, FR., Mariani, JJ., Brooks, DJ., et al.[2022]

In a meta-analysis of 16 trials, nabilone was associated with significantly higher rates of drowsiness, dizziness, and dry mouth compared to placebo, indicating a notable risk of these side effects.

Dronabinol also showed increased occurrences of dry mouth, dizziness, and headache compared to placebo, but the overall severity of adverse events was generally mild-to-moderate, suggesting that the benefits may outweigh the risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Dronabinol and Nabilone: A Systematic Review and Meta-Analysis of Clinical Trials. Bajtel, Á., Kiss, T., Tóth, B., et al.[2022]

Nabilone (Cesamet) has not been approved by the FDA for marketing, contrary to previous claims, while dronabinol (Marinol) is the synthetic cannabinoid that has received FDA approval.

Corrections were made regarding the authors' affiliation and inaccuracies in references from the original article, ensuring the integrity of the published information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erratum. [2010]

In a study involving 11 daily marijuana smokers, nabilone (a synthetic THC analog) significantly reduced withdrawal symptoms and decreased marijuana relapse compared to placebo, indicating its potential as a treatment for marijuana dependence.

While nabilone effectively alleviated irritability and disrupted sleep and food intake associated with withdrawal, it did modestly impair psychomotor performance, suggesting a need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nabilone decreases marijuana withdrawal and a laboratory measure of marijuana relapse. Haney, M., Cooper, ZD., Bedi, G., et al.[2022]

Current treatments for cannabis use disorders are not very effective, highlighting a significant health issue worldwide.

Preliminary evidence suggests that cannabidiol (CBD) may help reduce cannabis use, withdrawal symptoms, and cravings, but more extensive trials with larger patient groups and longer durations are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol pharmacotherapy for delta-9-tetrahidrocannabinol dependence Pavlovsky, F., Groisman, R., Hurtado, AK., et al.[2022]

In a study involving 8 children and adolescents with various medical conditions, delta 9-THC (Dronabinol) showed promising therapeutic effects, including reduced spasticity, improved dystonia, and anticonvulsive action, with doses ranging from 0.04 to 0.12 mg/kg per day.

While low doses of THC increased initiative and interest in surroundings, higher doses led to disinhibition and restlessness; however, discontinuation of treatment did not result in any adverse effects, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the application of cannabis in paediatrics and epileptology. Lorenz, R.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4701763/

Cannabinoid Ligands and Alcohol Addiction - PubMed Central Some observations indicate that cannabinoid receptor antagonists may be useful for the treatment of alcohol dependence and addiction, which is a major health ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8286984/

Effects of cannabis use on alcohol consumption in a ... Cannabis is commonly used among people who drink alcohol, but evidence suggests a nuanced relationship between alcohol consumption and cannabis use.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955395920303017

Reductions in alcohol use following medical cannabis ... Following medical cannabis initiation, 44% (n=419) of participants reported decreases in alcohol use frequency over 30 days, and 34% (n=323) decreased the ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07176208

NCT07176208 | Clinical Study to Evaluate the Effects of ... This study aims to evaluate the dose-dependent effects of oral Δ9-THC alone and in combination with alcohol (0.08% BAC [Blood Alcohol Concentration]) on driving ...

5. zeweed.com zeweed.com/en/u-s-federal-study-confirms-cbds-effectiveness-in-treating-alcoholism/

U.S. federal study confirms CBD's effectiveness in treating ... A federal study conducted in the United States shows that CBD is effective in the treatment of alcoholism.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9232221/

Alcohol and Cannabinoids – From the Editors - PMC Rates of alcohol use disorder (AUD) are higher among cannabis users relative to nonusers, with approximately 60% of individuals with current cannabis use ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2722956/

THE EFFECT OF CANNABIS COMPARED WITH ... Crouch found that marijuana use contributed to the demise of 168 fatally-injured truckers in all cases in which the serum concentration of THC exceeded 1 ng/mL.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/018651s033lbl.pdf

marinol - accessdata.fda.gov Patients with a history of substance abuse or dependence, including marijuana or alcohol, may be more likely to abuse MARINOL as well. Assess each patient's ...

9. samhsa.gov samhsa.gov/substance-use/learn/marijuana/risks

Know the Effects, Risks and Side Effects of Marijuana Research shows that people who use marijuana are more likely to have relationship problems, worse educational outcomes, lower career achievement, and reduced ...