NCT07603518

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
3mo left

Started Jun 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 18, 2026

Last Update Submit

May 18, 2026

Conditions

Cannabis

Keywords

CannabinoidsPharmacologyContaminationHemp lotion

Outcome Measures

Primary Outcomes (1)

  • Change in concentration of oral fluid cannabinoids

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

    Days 1-7 and Day 14

Secondary Outcomes (3)

  • Change in concentration of blood cannabinoids

    Days 1-7 and Day 14

  • Change concentration of urine cannabinoids

    Days 1-7 and Day 14

  • Change in the number of total minutes of sleep

    Days 1-7

Study Arms (1)

Topical CBD Product with low level of THC

EXPERIMENTAL

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

Drug: CBDDrug: THC

Interventions

CBDDRUG

CBD will be topically applied

Topical CBD Product with low level of THC
THCDRUG

THC will be topically applied

Topical CBD Product with low level of THC

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Tory Spindle, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lizzie Wilkerson

CONTACT

4105500529lizziewilkerson307@gmail.com

Tory Spindle

CONTACT

tspindle@jhmi.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 22, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

US(1)