INTERVENTIONALRECRUITINGNCT07603518
The Pharmacokinetics of a Hemp-Based Topical Cannabinoid Product in a Sanitized and Controlled Environment
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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.gov↗last source update 2026-09-03
What this record can show
Protocol only - no registry results posted
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Study at a glance
- Phase
- PHASE1
- Enrollment
- 20 (ESTIMATED)
- Start date
- 2026-05-26
- Sponsor
- Johns Hopkins University
- Design
- NA · SINGLE GROUP · BASIC SCIENCE
- Locations
- 1
- Results record
- Not present in registry snapshot
Participants (N = 6) will complete an 7-day residential study using a high CBD/low D9-THC lotion. The lotion is applied to the participants' upper arms four times daily in a sanitized and controlled procedure that eliminates the potential for specimen contamination. Oral fluid (OF) is collected before and after application (six samples/day); blood and urine are collected once/day. On discharge day, participants provide an intentionally contaminated OF sample. Participants return after a 7-day washout to provide 4 additional OF specimens, one "clean" and three more intentionally contaminated samples over a two-hour course.
CannabisCannabinoidsPharmacologyContaminationHemp lotion
Linked local records
Related local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Conditions
No published condition report matched.
Cannabinoids and active compounds
Medicines
No exact medicine-name link was found.
Interventions
What was registered
DRUGCBD
CBD will be topically applied
DRUGTHC
THC will be topically applied
Eligibility
Population and criteria
- Sex
- ALL
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Accepted
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.
primary outcomes
primary measures
Change in concentration of oral fluid cannabinoids
Time frame: Days 1-7 and Day 14
Concentration of cannabinoids will be measured in oral fluid (unit of measurement: nanograms/mL)
secondary outcomes
secondary measures
Change in concentration of blood cannabinoids
Time frame: Days 1-7 and Day 14
Concentration of cannabinoids will be measured in blood (unit of measurement: nanograms/mL)
Change concentration of urine cannabinoids
Time frame: Days 1-7 and Day 14
Concentration of cannabinoids will be measured in urine (unit of measurement: nanograms/mL)
Change in the number of total minutes of sleep
Time frame: Days 1-7
Change in sleep patterns. Change in the number of total minutes of sleep will be measured via vital monitoring and sleep profiling
Publications
Locally readable linked articles
0No exact PMID-linked public article is currently readable locally.
Snapshot provenance
- Snapshot
- 40e093e3-261a-4c80-8a10-ec55bacb087b
- Retrieved
- 11/09/2026, 14:15:37
- SHA-256
- a568da178d153354910c1d66ad48399a6a00cf7f4a8d14248c196ac733fc1823