Health TrialsbyHealthPanel

The Pharmacokinetics of a Hemp-Based Topical Product

ConditionCannabis
Trial statusRecruiting
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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • CBD

    Drug

    CBD will be topically applied

  • THC

    Drug

    THC will be topically applied

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Topical CBD Product with low level of THCExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in concentration of oral fluid cannabinoids

Concentration of cannabinoids will be measured in oral fluid (unit of measurement: nanograms/mL)

Time frame
Days 1-7 and Day 14

Secondary outcomes

1

Change in concentration of blood cannabinoids

Concentration of cannabinoids will be measured in blood (unit of measurement: nanograms/mL)

Time frame
Days 1-7 and Day 14
2

Change concentration of urine cannabinoids

Concentration of cannabinoids will be measured in urine (unit of measurement: nanograms/mL)

Time frame
Days 1-7 and Day 14
3

Change in the number of total minutes of sleep

Change in sleep patterns. Change in the number of total minutes of sleep will be measured via vital monitoring and sleep profiling

Time frame
Days 1-7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

RTI International

Collaborator

Substance Abuse And Mental Health Administration

Collaborator

Source ClinicalTrials.gov
Apply now