20 Participants NeededMy employer runs this trial

Hemp-Based Topical Product for Cannabis Research

LW
TS
Overseen ByTory Spindle
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a hemp-based CBD (cannabidiol) lotion with a small amount of THC (a compound in cannabis that can cause a high) affects the body when used once or over time. The researchers aim to understand how the body absorbs and processes the lotion. Participants should be in good health and have prior experience with cannabis or CBD products, but must test negative for recent cannabis use. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial does not clearly state if you must stop taking your current medications, but it mentions that if your medications might interfere with the study or your safety, you may not be eligible to participate. It's best to discuss your specific medications with the trial team.

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

Research has shown that creams and lotions with CBD and low THC levels are usually safe for most people. Studies indicate that CBD and similar compounds are unlikely to cause allergic reactions. Some reports even suggest they might help reduce skin allergies.

However, limited information exists about CBD's overall safety, so some risks might not be fully known yet. The FDA has expressed concerns about possible risks associated with using CBD. It's important to remember that while CBD is often sold as a supplement, it is not regulated like a medicine.

In summary, while CBD creams with low THC seem safe for many, more research is needed to fully understand their effects. Participants should consider this information before joining the trial.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about this treatment because it combines CBD with low levels of THC in a topical form, offering a new way to address conditions that might benefit from cannabis-based therapy. Unlike other treatments that are usually taken orally or smoked, this topical product allows for localized application, potentially reducing side effects and enhancing targeted relief. The inclusion of both CBD and THC leverages the therapeutic benefits of both cannabinoids, which could provide a broader range of symptom relief compared to CBD-only products. This unique combination and delivery method might offer more effective and safer options for individuals seeking cannabis-based treatment.

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

Research has shown that creams with cannabidiol (CBD) can benefit the skin by reducing swelling, itching, and pain. Studies have found that applying CBD directly to the skin may alleviate pain and swelling, particularly for conditions like arthritis. Some individuals report that CBD creams are more effective than common painkillers like ibuprofen for certain areas. While the evidence is promising, further research is needed to fully understand its effectiveness for other conditions. In this trial, participants will use a topical CBD product containing low levels of THC, which may also aid in reducing pain and swelling in specific areas.46789

Who Is on the Research Team?

TS

Tory Spindle, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-55 who are in good health, have used cannabis or CBD before, test negative for recent drug and alcohol use, are not pregnant or nursing (if female), and meet certain weight and blood pressure requirements.

Inclusion Criteria

* Have provided written informed consent
* Have a body mass index (BMI) in the range of 18 to 38 kg/m2
* 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
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants apply a high CBD/low D9-THC lotion to their upper arms four times daily for 7 days in a sanitized and controlled environment

7 days
Residential stay with daily monitoring

Washout

Participants undergo a 7-day washout period before returning for additional sample collection

7 days

Follow-up

Participants return after the washout period to provide additional oral fluid specimens

1 day
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • CBD
  • THC

Trial Overview

The study tests how the body absorbs a hemp-based lotion containing CBD with low THC levels when applied to the skin, both after one use and after repeated uses. The research takes place in a controlled setting.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Topical CBD Product with low level of THCExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

RTI International

Collaborator

Trials
201
Recruited
942,000+

Substance Abuse And Mental Health Administration

Collaborator

Trials
1
Recruited
80+

Citations

Topical cannabidiol (CBD) in skin pathology - PMC - NIH

Topical cannabis has anti-inflammatory, anti-itching, analgesics, wound healing and anti-proliferative effects on the skin.

Topical cannabidiol is well tolerated in individuals with ... - PMC

Cannabidiol (CBD) is a potential therapeutic for pain management. Yet, there exists a dearth of studies of its tolerability and efficacy, ...

Cannabidiol (CBD): What we know and what we don't

One animal study from the European Journal of Pain suggests CBD could help lower pain and inflammation due to arthritis when applied to skin.

THC Lotion vs. CBD Lotion: Concentration, Uses, Side Effects

Both THC and CBD lotions are marketed as effective in providing localized relief for pain, inflammation, and skin conditions. Although THC is ...

Cannabidiol (CBD) Products for Pain

Fifteen of the 16 RCTs were negative: no greater pain-relieving effect for CBD than for placebo. Meta-analyses link CBD to increased rates of serious adverse ...

Safety and Sourcing of Topical Cannabinoids - PMC - NIH

Cannabinoids do not appear to be highly allergenic or common contact allergens thus far and might actually be helpful in attenuating allergic ...

Cannabidiol (CBD) – Potential Harms, Side Effects, and ...

CBD is typically derived from hemp because of its low THC concentration, and THC is typically derived from marijuana plants. There is currently only one FDA ...

What to Know About Products Containing Cannabis and CBD

The FDA has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any ...

CBD: Safe and effective?

Interested in using CBD? Here's what you need to know about the risks and benefits of using this drug.