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Not yet recruiting NCT07603518

The Pharmacokinetics of a Hemp-Based Topical Product

Phase I Interventional Cannabis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CBD, THC.
Who it may be relevant to
Registry conditions: Cannabis. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Pharmacokinetics of a Hemp-Based Topical Cannabinoid Product in a Sanitized and Controlled Environment

Overview

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.

Detailed description

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.

Interventions

  • Drug CBD
    CBD will be topically applied
  • Drug THC
    THC will be topically applied

Primary outcome measures

  • Change in concentration of oral fluid cannabinoids [Time frame: Days 1-7 and Day 14]
Secondary outcome measures (3)
  • Change in concentration of blood cannabinoids [Time frame: Days 1-7 and Day 14]
  • Change concentration of urine cannabinoids [Time frame: Days 1-7 and Day 14]
  • Change in the number of total minutes of sleep [Time frame: Days 1-7]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Behavioral Pharmacology Research Unit — Baltimore

Identifiers

NCT: NCT07603518 · IRB00542166 · 1-312-0218758-67045L

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗