CannabisPhase 1NCT07603518
The Pharmacokinetics of a Hemp-Based Topical Product
A Phase 1 study testing CBD and THC in people with Cannabis, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis
- What is being tested?
- CBD and THC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2026to 1 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tory Spindle contact
United States1 site, 1 recruiting
- Recruiting
Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
Tory Spindle, Ph.D.
About this study
Official title: The Pharmacokinetics of a Hemp-Based Topical Cannabinoid Product in a Sanitized and Controlled Environment
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.
Read the 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.
- Conditions
- Cannabis
- Being tested
- CBD, THC
- Keywords
- Cannabinoids, Pharmacology, Contamination, Hemp lotion
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBDDrug
CBD will be topically applied
THCDrug
THC will be topically applied
| Study group | Role | What they receive |
|---|---|---|
| Topical CBD Product with low level of THC | Experimental | Participants will topically apply a high CBD-product that also contains low levels of THC. Receives: Drug: CBD; Drug: THC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in concentration of oral fluid cannabinoids
Concentration of cannabinoids will be measured in oral fluid (unit of measurement: nanograms/mL)
Measured: Days 1-7 and Day 14
Secondary outcomes (3)
Change in concentration of blood cannabinoids
Concentration of cannabinoids will be measured in blood (unit of measurement: nanograms/mL)
Measured: Days 1-7 and Day 14
Change concentration of urine cannabinoids
Concentration of cannabinoids will be measured in urine (unit of measurement: nanograms/mL)
Measured: Days 1-7 and Day 14
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
Measured: Days 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start26 May 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CannabisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- RTI International, Substance Abuse And Mental Health Administration
- Responsible party
- Sponsor
- Investigators
- Tory Spindle, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603518
- Sponsor's protocol ID
- IRB00542166
- Other IDs
- 1-312-0218758-67045L
- Status last verified
- Sep 2026
- First submitted
- 18 May 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics of a Hemp-Based Topical Cannabinoid Product in a Sanitized and Controlled Environment
- ClinicalTrials.gov ID
- NCT07603518
- Acronym / sponsor ID
- IRB00542166
- Conditions
- Cannabis
- Keywords
- Cannabinoids, Pharmacology, Contamination, Hemp lotion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- RTI International, Substance Abuse And Mental Health Administration
- Study start
- 26 May 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical CBD Product with low level of THC | Experimental | Drug: CBD, Drug: THCParticipants will topically apply a high CBD-product that also contains low levels of THC. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBDCBD will be topically applied | Drug | Topical CBD Product with low level of THC |
| THCTHC will be topically applied | Drug | Topical CBD Product with low level of THC |
Primary outcome
Change in concentration of oral fluid cannabinoids
Time frame: Days 1-7 and Day 14
Concentration of cannabinoids will be measured in oral fluid (unit of measurement: nanograms/mL)
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tory Spindle contact
Tory Spindle, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBD and THC in people with Cannabis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lizzie Wilkerson (4105500529, lizziewilkerson307@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in concentration of oral fluid cannabinoids (time frame: Days 1-7 and Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.