THC + Beta-Myrcene Effects on Cannabis Use

Overseen By Ryan Vandrey, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Johns Hopkins University

Must not be taking: OTC drugs, Herbal supplements

Disqualifiers: Seizure disorder, Psychosis, others

Compensation: Varies

Number of Visits: 9

Duration: 9 sessions

32 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized b-myrcene and THC administered via inhalation.

Do I need to stop taking my current medications to join the trial?

Yes, you may need to stop taking certain medications. You cannot use over-the-counter drugs, supplements, or vitamins within 14 days of the study sessions, and prescription medications must be stopped within a specific time frame unless they are birth control.

What evidence supports the effectiveness of the drug THC + Beta-Myrcene for reducing cannabis use?

Research shows that dronabinol (oral THC) has been studied for its effects on cannabis withdrawal and cognitive performance, suggesting potential benefits for cannabis use disorders. Additionally, cannabinoids, including THC, have shown therapeutic potential in various conditions, indicating their possible effectiveness in managing cannabis use. ^{1 2 3 4 5}

Is THC and Beta-Myrcene treatment generally safe for humans?

Research shows that cannabis-based treatments, including THC, are generally safe with a low incidence of severe side effects, though common mild side effects include nausea, dry mouth, dizziness, and sleepiness. Women may experience more adverse effects than men, possibly due to different cannabis compositions used. ^{6 7 8 9 10}

How is the THC + Beta-Myrcene drug different from other cannabis-based drugs?

The THC + Beta-Myrcene drug is unique because it explores the potential synergy between THC and the terpenoid beta-myrcene, which may enhance therapeutic effects and reduce side effects compared to using THC alone. This combination leverages the 'entourage effect', where different cannabis compounds work together to potentially improve outcomes in treating conditions like pain and anxiety. ^{11 12 13 14 15}

Research Team

Ryan Vandrey, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adults aged 18-55 in good health with a BMI of 18-36 kg/m2. Participants must not be pregnant, nursing, or have high blood pressure; they should test negative for drugs (except cannabis) and demonstrate cognitive competency. Those using certain medications or with significant medical/psychiatric conditions are excluded.

Inclusion Criteria

Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg

My overall health is good, as confirmed by recent medical exams and tests.

Have a body mass index (BMI) in the range of 18 to 36 kg/m2

Exclusion Criteria

I have anemia or I donated blood in the last 30 days.

I am not on medication that affects the study, except for birth control.

I haven't taken any over-the-counter drugs, supplements, or vitamins in the last 14 days that could affect the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete 9 acute drug administration periods with THC, myrcene, or placebo in a randomized order

9 sessions

9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Beta-Myrcene
• THC

Trial Overview The study investigates the effects of vaporized THC and Beta-Myrcene on participants compared to a placebo. It aims to understand how these substances are processed by the body and their impact when inhaled.

Participant Groups

Group I: Vaporized low beta-myrcene Experimental Treatment 1 Intervention

2mg of vaporized beta-myrcene

Group II: Vaporized low THC and low beta-myrcene Experimental Treatment 2 Interventions

15mg vaporized THC with 2mg vaporized beta-myrcene

Group III: Vaporized low THC and high beta-myrcene Experimental Treatment 2 Interventions

15mg vaporized THC with 9mg vaporized beta-myrcene

Group IV: Vaporized low THC alone Experimental Treatment 1 Intervention

15mg of vaporized pure THC

Group V: Vaporized high beta-myrcene Experimental Treatment 1 Intervention

9mg of vaporized beta-myrcene

Group VI: Vaporized high THC and low beta-myrcene Experimental Treatment 2 Interventions

30mg vaporized THC with 2mg vaporized beta-myrcene

Group VII: Vaporized high THC and high beta-myrcene Experimental Treatment 2 Interventions

30mg vaporized THC with 9mg vaporized beta-myrcene

Group VIII: Vaporized high THC alone Experimental Treatment 1 Intervention

30mg of vaporized pure THC

Group IX: Placebo Placebo Group 1 Intervention

Placebo (ambient air)

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

A daily dose of 40 mg of rimonabant for 15 days effectively reduced the physiological effects of smoked cannabis, such as tachycardia, similar to a single higher dose of 90 mg on the first day of treatment.

While the 40 mg dose significantly decreased subjective effects of cannabis on day 8, it did not maintain this effect by day 15, indicating that repeated dosing may not consistently reduce the subjective experience of cannabis effects over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single and multiple doses of rimonabant antagonize acute effects of smoked cannabis in male cannabis users. Huestis, MA., Boyd, SJ., Heishman, SJ., et al.[2019]

In a study of 2,112 adult patients with chronic pain, 92.5% reported improvement in their primary symptoms after using cannabis-based oral formulations, indicating high efficacy as an adjuvant treatment.

The majority of patients experienced minimal side effects, with 71.7% reporting none, and the most common mild side effects, such as somnolence and dizziness, tended to decrease over time, suggesting that these formulations are safe for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex-Dependent Prescription Patterns and Clinical Outcomes Associated With the Use of Two Oral Cannabis Formulations in the Multimodal Management of Chronic Pain Patients in Colombia. Moreno-Sanz, G., Madiedo, A., Hernandez, P., et al.[2022]

In a study with 13 daily cannabis smokers, dronabinol (oral THC) was found to dose-dependently reduce cannabis withdrawal symptoms without causing significant cognitive impairment or adverse side effects, even at doses up to 120mg per day.

While dronabinol did not change the subjective effects of smoked cannabis, it did attenuate the increase in heart rate caused by cannabis at higher doses, suggesting a potential therapeutic role in managing withdrawal symptoms for those trying to quit cannabis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dose effects of short-term dronabinol (oral THC) maintenance in daily cannabis users. Vandrey, R., Stitzer, ML., Mintzer, MZ., et al.[2022]

A meta-analysis of 72 controlled clinical trials indicates that cannabinoids have significant therapeutic potential for various conditions, including as antiemetics, appetite stimulants, and analgesics.

Cannabinoids may be beneficial in treating debilitating diseases such as cancer and AIDS, as well as neurological disorders like multiple sclerosis and epilepsy, highlighting their diverse applications in medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabinoids in medicine: A review of their therapeutic potential. Ben Amar, M.[2022]

In a 2-year observational study of 585 adult patients using medical cannabis, there was a significant increase in the authorization of THC-dominant and CBD-dominant products, indicating a shift in prescribing patterns.

Patients using CBD-dominant or balanced (THC:CBD) products reported greater improvements in anxiety and well-being compared to those using THC-dominant products, suggesting that the cannabinoid profile can influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Authorization Patterns, Safety, and Effectiveness of Medical Cannabis in Quebec. Kalaba, M., MacNair, L., Peters, EN., et al.[2021]

In a study of 429 patients with chronic noncancer pain, women reported more adverse effects from medical cannabis than men, despite similar weight-adjusted doses of cannabis consumed by both sexes.

The differences in adverse effects may be linked to the specific phytocannabinoid compositions consumed by women, who used higher doses of CBD and CBC, suggesting that tailoring cannabis treatments based on sex could improve safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex differences in medical cannabis-related adverse effects. Aviram, J., Lewitus, GM., Vysotski, Y., et al.[2023]

The safety of cannabis and cannabinoid medications is a significant concern, and while some safety information can be drawn from recreational use studies, medical and recreational users may experience different effects.

There is a pressing need for long-term safety monitoring of cannabinoid use in patients, as clinical experience is still developing, which will help inform both therapeutic decisions and public policy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety issues concerning the medical use of cannabis and cannabinoids. Ware, MA., Tawfik, VL.[2019]

The analysis of 16 systematic reviews and 9 additional randomized-controlled trials found that medicinal cannabis can effectively help manage chronic pain and spasticity in multiple sclerosis patients, as well as stimulate appetite and improve nausea in cancer and HIV/AIDS patients, although the benefits are often small.

While there are reported adverse effects associated with cannabis medicine, severe adverse effects are rare, highlighting the need for more extensive and methodologically sound studies to establish reliable treatment guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of medicinal cannabis: results of the CaPRis study]. Hoch, E., Friemel, C., Schneider, M., et al.[2019]

In a study involving 30 HIV-positive marijuana smokers, both smoked marijuana and lower doses of dronabinol (10 and 20 mg) were well tolerated and significantly increased caloric intake, particularly in those with muscle mass loss.

The highest dose of dronabinol (30 mg) was poorly tolerated by some participants, indicating that while both treatments can enhance food intake, careful dosing is important for safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dronabinol and marijuana in HIV(+) marijuana smokers: acute effects on caloric intake and mood. Haney, M., Rabkin, J., Gunderson, E., et al.[2022]

References

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

Single and multiple doses of rimonabant antagonize acute effects of smoked cannabis in male cannabis users. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Sex-Dependent Prescription Patterns and Clinical Outcomes Associated With the Use of Two Oral Cannabis Formulations in the Multimodal Management of Chronic Pain Patients in Colombia. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

The dose effects of short-term dronabinol (oral THC) maintenance in daily cannabis users. [2022]

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

Cannabinoids in medicine: A review of their therapeutic potential. [2022]

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

Authorization Patterns, Safety, and Effectiveness of Medical Cannabis in Quebec. [2021]

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

Sex differences in medical cannabis-related adverse effects. [2023]

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

Safety issues concerning the medical use of cannabis and cannabinoids. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of medicinal cannabis: results of the CaPRis study]. [2019]

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

An Updated Analysis of Clinical Outcome Measures Across Patients From the UK Medical Cannabis Registry. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Dronabinol and marijuana in HIV(+) marijuana smokers: acute effects on caloric intake and mood. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects. [2022]

12. England pubmed.ncbi.nlm.nih.gov

A pharmacological characterization of Cannabis sativa chemovar extracts. [2021]

13. Ireland pubmed.ncbi.nlm.nih.gov

Physiochemical and pharmacological characterization of a Delta(9)-THC aerosol generated by a metered dose inhaler. [2019]

14. Germany pubmed.ncbi.nlm.nih.gov

Comparison of smoked marijuana and oral Delta(9)-tetrahydrocannabinol in humans. [2013]

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

Cannabis Pharmacology: The Usual Suspects and a Few Promising Leads. [2018]