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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the body processes and reacts to THC and beta-myrcene, both compounds found in cannabis. Researchers are testing various combinations of these compounds to observe their effects on cannabis users. The trial includes several groups: some receive only THC, others only beta-myrcene, and some a mix of both. It seeks participants who are regular cannabis users, in good general health, and can pass a drug screening for substances other than cannabis. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination.

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.

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

Research shows that THC, the main active ingredient in cannabis, can cause side effects like dizziness and tiredness. It might also impair thinking and memory. Some reports have linked vaping THC to breathing problems, including serious lung illnesses, often related to illegally made products.

Beta-myrcene, a compound found in many plants, is generally safe but can irritate the skin and eyes. It's also flammable, so handle it with care. Limited research exists on using THC and beta-myrcene together, but the same precautions apply. Always consider potential risks and consult a healthcare professional with any questions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the potential of THC combined with beta-myrcene for cannabis use because this approach targets the entourage effect, where active compounds in cannabis work together to enhance or modify effects. Most treatments for reducing cannabis use focus on behavioral therapies or replacement strategies. Unlike these, the combination of THC and beta-myrcene could modulate the psychoactive effects, potentially reducing the desire to consume cannabis. This novel approach might offer a more tailored and effective way to manage cannabis use by leveraging specific cannabis compounds in precise formulations.

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

Research has shown that THC, one of the treatments in this trial, can ease withdrawal symptoms for those reducing cannabis use. Studies found that dronabinol, a type of THC, was more effective than a placebo in alleviating these symptoms.

Beta-myrcene, another treatment under study, is known for its anti-inflammatory and calming effects. However, it might also impair focus on tasks like driving.

This trial will explore the effects of combining THC with beta-myrcene. Evidence suggests that beta-myrcene can interact with THC to activate certain brain receptors, potentially enhancing some effects of THC. However, the specific benefits of this combination for cannabis use remain under investigation. ^{6 7 8 9 10}

Who Is on the Research Team?

Ryan Vandrey, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10212270/

The Effects of β-myrcene on Simulated Driving and Divided ... β-myrcene was associated with statistically significant reductions in speed control and increased errors on a divided attention task.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8326332/

Myrcene—What Are the Potential Health Benefits of This ... β-Myrcene found within the cannabis plant possesses anti-inflammatory, analgesic and sedative activities, which is additional to the effects of classical ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05432284

Behavioral Pharmacology of THC and Beta-Myrcene The study will help us understand the individual and interactive effects of THC and b-myrcene, two common constituents found in cannabis.

4. withpower.com withpower.com/trial/phase-1-cannabis-use-7-2022-8f1c8

THC + Beta-Myrcene Effects on Cannabis Use 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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0161813X23001699

Characterizing cannabis-prevalent terpenes for ... No significant protective effects of terpenes were observed following t-BHP (0–200 µM) administration, with some enhanced toxicity instead demonstrated from ...

6. fishersci.com fishersci.com/store/msds?partNumber=AC128080050&productDescription=MYRCENE%2CTECH.%2C+90%2B%25%2CSTABI+5ML&vendorId=VN00032119&countryCode=US&language=en

SAFETY DATA SHEET Ensure adequate ventilation, especially in confined areas. Personal Protective Equipment. Eye/face Protection. Wear appropriate protective ...

7. agilent.com agilent.com/cs/library/msds/TRP-150-1_NAEnglish.pdf?srsltid=AfmBOorPe4mHMwU9iPEwtoiG0ayYniSx0A-QZhFjVPFPAf0YhTlud0Z8

beta-Myrcene Standard Hazard statements. Highly flammable liquid and vapor. Causes serious eye irritation. May cause drowsiness or dizziness. · Precautionary ...

8. vigon.com vigon.com/product/myrcene/?doc=MSDS/500255_vigon_sds_us_english.pdf&namee=MyrceneSDS

500255 myrcene safety data sheet Signal word. Danger. Hazard statement. Flammable liquid and vapor. May be fatal if swallowed and enters airways. Causes skin irritation.

9. cdn.caymanchem.com cdn.caymanchem.com/cdn/msds/21720m.pdf

Safety Data Sheet Flammable Liquids 3. H226 Flammable liquid and vapor. d. ~GHS08 Health hazard. Carcinogenicity 2. H351 Suspected of causing cancer. Toxic ...

10. sigmaaldrich.com sigmaaldrich.com/DE/de/sds/ALDRICH/W276200?srsltid=AfmBOooOGCLE-qa_U4s3Ebh2drE4y1SltF_9wt27OWnLEHLLH5N7vwxt

SAFETY DATA SHEET Hazard Statements. H226. Flammable liquid and vapor. H304. May be fatal if swallowed and enters airways. H315. Causes skin irritation. H317. May ...