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

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What evidence supports the effectiveness of the drug THC for reducing alcohol consumption?

Research shows that dronabinol, a form of THC, can help reduce withdrawal symptoms and improve treatment retention in cannabis dependence, suggesting it might help with alcohol withdrawal as well. Additionally, dronabinol has been effective in reducing pain when used with opioids, indicating its potential to support other treatments. ^{1 2 3 4 5}

Is THC generally safe for human use?

THC, in forms like dronabinol, has been studied for safety and is generally considered safe with mild-to-moderate side effects such as dry mouth, dizziness, and headache. These side effects are usually temporary and acceptable compared to the benefits, but more research is needed to fully understand its safety profile. ^{3 6 7 8 9}

How does the drug Dronabinol differ from other treatments for reducing alcohol consumption?

Dronabinol (THC) is unique because it is primarily known for its use in treating nausea and appetite loss in conditions like cancer and HIV/AIDS, and it works by interacting with cannabinoid receptors in the brain. Unlike traditional alcohol reduction treatments, Dronabinol's potential effects on alcohol consumption are not well-studied, making it a novel approach in this context. ^{9 10 11 12 13}

What is the purpose of this trial?

Alcohol and cannabis are often used together such that their effects overlap, but little is known about the neural mechanisms that underlie simultaneous use. High doses of THC have not been well-studied in the laboratory, and it is unclear how high doses of THC may impact alcohol consumption patterns. The proposed study will explore the effects of oral THC (20mg dronabinol) vs. placebo on neural reward, alcohol self-administration and naturalistic co-use patterns.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Nabilone decreases marijuana withdrawal and a laboratory measure of marijuana relapse. [2022]

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

Efficacy of dronabinol as an adjuvant treatment for chronic pain patients on opioid therapy. [2013]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Safety of Dronabinol and Nabilone: A Systematic Review and Meta-Analysis of Clinical Trials. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Dronabinol for the treatment of cannabis dependence: a randomized, double-blind, placebo-controlled trial. [2022]

5. Argentina pubmed.ncbi.nlm.nih.gov

Cannabidiol pharmacotherapy for delta-9-tetrahidrocannabinol dependence [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

The emerging role of cannabinoid neuromodulators in symptom management. [2023]

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

Erratum. [2010]

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

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

9. Germany pubmed.ncbi.nlm.nih.gov

Reinforcing effects of oral Delta9-THC in male marijuana smokers in a laboratory choice procedure. [2022]

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

Unintentional ingestion of putative delta-8 tetrahydrocannabinol by two youth requiring critical care: a case report. [2023]

11. Sweden pubmed.ncbi.nlm.nih.gov

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

12. Israel pubmed.ncbi.nlm.nih.gov

The Impact of Δ9-THC on the Psychological Symptoms of Anorexia Nervosa: A Pilot Study. [2021]

13. United States 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. [2018]