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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
Disqualifiers: Psychoactive drugs, Significant illness, Oral disease, others
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 study will evaluate the pharmacokinetic effects of acute and chronic dosing of a hemp-based cannabidiol (CBD) topical lotion with low levels of delta-9-tetrahydrocannabinol (THC) in a sanitized and controlled environment.

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
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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+

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