The Pharmacokinetics of a Hemp-Based Topical Product
ConditionCannabis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorJohns Hopkins University
About 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CBD
- THC
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Johns Hopkins University
Lead sponsor
RTI International
Collaborator
Substance Abuse And Mental Health Administration
Collaborator
Source ClinicalTrials.gov