Hemp-based CBD topical lotion pharmacokinetics in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study evaluates the pharmacokinetics of a hemp-derived CBD topical lotion with low delta-9-THC. Six healthy adults will undergo a 7‑day residential period where the lotion is applied to the upper arms four times daily under controlled, sanitized conditions. Biological samples (oral fluid, blood, and urine) are collected regularly to characterize absorption and elimination, with a special contaminated oral fluid sample collected at discharge and again after a 7‑day washout. The trial aims to determine how acute and chronic topical dosing affects systemic exposure in a controlled setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Have provided written informed consent
* Be between the ages of 18 and 55
* Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
* Test negative for recent cannabis use in urine at the screening visit and again upon admission for the inpatient stay.
* Test negative for other drugs of abuse, including alcohol, at the screening visit and again upon admission for the inpatient stay.
* Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at each study visit.
* 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
* Report prior experience using cannabis or CBD products.

Exclusion Criteria:

* Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the month prior to the screening visit.
* History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.
* Current use of medications which, in the opinion of the investigator or medical monitor, will interfere with the study results or the safety of the subject.
* History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.
* Known allergy to any ingredients in the study drug.
* Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.

Where it's running

• Behavioral Pharmacology Research Unit
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Tory Spindle, PhD — Johns Hopkins University
• Study coordinator: Lizzie Wilkerson
• Email: lizziewilkerson307@gmail.com
• Phone: 4105500529

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.