Recruiting
Phase 1

CBD with THC

Sponsor:

Johns Hopkins University

Code:

NCT07603518

Conditions

Cannabis

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

CBD

THC

Study Details

Brief summary:

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.

Conditions

Cannabis

Study ID

NCT07603518

Start date

May 26, 2026

Status verified date

Sep, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Topical CBD Product with low level of THC

Participants will topically apply a high CBD-product that also contains low levels of THC.

Interventions

CBD

CBD will be topically applied

THC

THC will be topically applied

Primary outcome measure

  • Change in concentration of oral fluid cannabinoids [ Time Frame: Days 1-7 and Day 14 ]

Central Contacts and Locations

Central contacts

Lizzie Wilkerson

4105500529lizziewilkerson307@gmail.com

Tory Spindle

tspindle@jhmi.edu

Locations

Behavioral Pharmacology Research Unit

Recruiting

Baltimore, Maryland, United States, 21224

Principal Investigator:

Tory Spindle, Ph.D.

More Information

Sponsor

Johns Hopkins University

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Cannabinoids
  • Pharmacology
  • Contamination
  • Hemp lotion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-09-03.