CannabisPhase 1NCT04741477
The Pharmacokinetics and Pharmacodynamics of Hemp-based Topical Cannabinoid Products
A Phase 1 study testing CBD and THC in people with Cannabis and Drug Effect, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study will evaluate the pharmacokinetic and pharmacodynamic effects of hemp-based Cannabidiol (CBD) topical products (e.g., lotions, creams, patches) that contain low levels of delta-9-tetrahydrocannabinol (THC). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis, Drug Effect
- What is being tested?
- CBD and THC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2021to 16 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 each experimental session
- Test negative for other drugs of abuse, including alcohol, at the screening visit and upon arrival for each experimental session
- 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 19 to 36 kg/m^2
- Have head hair that is at least 4 cm (approximately one and a half inches) in length on the back of the head.
- 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.
- Have not donated blood in the prior 30 days.
- Have a smart phone, tablet, computer, etc. capable of recording videos and operating Redcap.
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.
- Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), vitamin(s), or prescription medications (with the exception of birth control prescriptions) within 14 days of study entry; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the subject.
- Use of hemp seeds or hemp oil in any form in the past 3 months.
- Use of dronabinol (Marinol) within the past 6 months.
- 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.
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- History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
- Known allergy to any ingredients in the active or placebo topical products.
- Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
- Epilepsy or a history of seizures.
- Individuals with anemia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
About this study
This study will evaluate the pharmacokinetic and pharmacodynamic effects of hemp-based Cannabidiol (CBD) topical products (e.g., lotions, creams, patches) that contain low levels of delta-9-tetrahydrocannabinol (THC).
Read the detailed description
A total of 5 topical cannabinoid products will be examined in this study. The study will be conducted in 5 discrete stages, one for each product. In each stage, participants (N=20), will be randomized to 1 of 2 double-blind drug conditions that entail the use of: 1) a topical product that contains CBD and a low amount of THC (N=15), or 2) a placebo topical product that does not contain cannabinoids (N=5), but which contains similar non-cannabinoid ingredients to the active product. Thus, overall 100 participants will complete the study (75 active, 25 placebo).
Participants in each stage will complete a three-phase outpatient protocol that will last a total of 17 days. Phase 1 (Day 1) will be an acute laboratory dosing session (approximately 7 hours in duration). Phase 2 (Days 2-10) will be an outpatient dosing period, during which participants will continue to use participants' assigned product twice daily (morning and evening) in participants' own environment. During Phase 2, participants will visit the laboratory for brief study sessions on Days 2, 3, 7, and 10. Phase 3, will consist of a final follow-up visit on Day 17, after a 1-week drug washout. Pharmacokinetic and pharmacodynamic assessments (subjective and cognitive effects) will be assessed during each phase.
- Conditions
- Cannabis, Drug Effect
- Being tested
- CBD, THC, Placebo
- 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
PlaceboDrug
a placebo product (without cannabinoids) 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 |
| Placebo topical product | Placebo comparator | Participants will topically apply a placebo product that does not contain cannabinoids. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urine cannabinoids
Concentration of cannabinoids will be measured in urine (unit of measurement: nanograms/mL)
Measured: Days 1, 2, 3, 7, 10, and 17
Change in Blood cannabinoids
Concentration of cannabinoids will be measured in blood (unit of measurement: nanograms/mL)
Measured: Days 1, 2, 3, 7, 10, and 17
Secondary outcomes (6)
Change in Oral fluid cannabinoids
Concentration of cannabinoids will be measured in oral fluid (unit of measurement: nanograms/mL)
Measured: Days 1, 2, 3, 7, 10, and 17
Change in Hair cannabinoids
Concentration of cannabinoids will be measured in hair (unit of measurement: nanograms/mL)
Measured: Days 1 and 17
Change in Subjective drug effects as assessed by the Drug Effect Questionnaire
Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect.
Measured: Days 1, 2, 3, 7, 10, and 17
Change in Cognitive performance as assessed by the Divided Attention Task
Cognitive performance will be evaluated with the Divided Attention Task. Will be measured as the mean distance (in computer pixels) of the mouse cursor from the central stimulus.
Measured: Days 1, 2, 3, 7, 10, and 17
Change in Working memory performance as assessed by the Paced Serial Addition Task
Working memory performance will be evaluated with the Paced Serial Addition Task (scores can range from 0-90) with 90 indicating perfect performance.
Measured: Days 1, 2, 3, 7, 10, and 17
Change in Psychomotor performance as assessed by the Digit Symbol Substitution Task
Psychomotor performance will be evaluated with the Digit Symbol Substitution Task. Will be measured as the number of correct trials within 90 seconds.
Measured: Days 1, 2, 3, 7, 10, and 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start14 Jul 2021
- Primary completion16 Sep 2022
- Study completion16 Sep 2022
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 5 topical cannabinoid products will be examined in this study. The study will be conducted in 5 discrete stages, one for each product. In each stage, participants (N=20), will be randomized to 1 of 2 double-blind drug conditions that entail the use of: 1) a topical product that contains CBD and a low amount of THC (N=15), or 2) a placebo topical product that does not contain cannabinoids (N=5), but which contains similar non-cannabinoid ingredients to the active product.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Responsible party
- Sponsor
- Investigators
- Tory Spindle, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741477
- Sponsor's protocol ID
- IRB00277556
- Other IDs
- 1-340-0216610-65527L
- Status last verified
- Mar 2023
- First submitted
- 2 Feb 2021
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics and Pharmacodynamics of Hemp-based Topical Cannabinoid Products
- ClinicalTrials.gov ID
- NCT04741477
- Acronym / sponsor ID
- IRB00277556
- Conditions
- Cannabis, Drug Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 16 Sep 2022 (actual)
- Study completion
- 16 Sep 2022 (actual)
- First posted
- 5 Feb 2021 (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 and pharmacodynamic effects of hemp-based Cannabidiol (CBD) topical products (e.g., lotions, creams, patches) that contain low levels of delta-9-tetrahydrocannabinol (THC).
Detailed description
A total of 5 topical cannabinoid products will be examined in this study. The study will be conducted in 5 discrete stages, one for each product. In each stage, participants (N=20), will be randomized to 1 of 2 double-blind drug conditions that entail the use of: 1) a topical product that contains CBD and a low amount of THC (N=15), or 2) a placebo topical product that does not contain cannabinoids (N=5), but which contains similar non-cannabinoid ingredients to the active product. Thus, overall 100 participants will complete the study (75 active, 25 placebo).
Participants in each stage will complete a three-phase outpatient protocol that will last a total of 17 days. Phase 1 (Day 1) will be an acute laboratory dosing session (approximately 7 hours in duration). Phase 2 (Days 2-10) will be an outpatient dosing period, during which participants will continue to use participants' assigned product twice daily (morning and evening) in participants' own environment. During Phase 2, participants will visit the laboratory for brief study sessions on Days 2, 3, 7, and 10. Phase 3, will consist of a final follow-up visit on Day 17, after a 1-week drug washout. Pharmacokinetic and pharmacodynamic assessments (subjective and cognitive effects) will be assessed during each phase.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 5 topical cannabinoid products will be examined in this study. The study will be conducted in 5 discrete stages, one for each product. In each stage, participants (N=20), will be randomized to 1 of 2 double-blind drug conditions that entail the use of: 1) a topical product that contains CBD and a low amount of THC (N=15), or 2) a placebo topical product that does not contain cannabinoids (N=5), but which contains similar non-cannabinoid ingredients to the active product.
| 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. |
| Placebo topical product | Placebo comparator | Drug: PlaceboParticipants will topically apply a placebo product that does not contain cannabinoids. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 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 each experimental session
- Test negative for other drugs of abuse, including alcohol, at the screening visit and upon arrival for each experimental session
Key exclusion criteria (11 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.
- Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), vitamin(s), or prescription medications (with the exception of birth control prescriptions) within 14 days of study entry; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the subject.
- Use of hemp seeds or hemp oil in any form in the past 3 months.
- Use of dronabinol (Marinol) within the past 6 months.
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 |
| Placeboa placebo product (without cannabinoids) will be topically applied | Drug | Placebo topical product |
Primary outcome
Change in Urine cannabinoids
Time frame: Days 1, 2, 3, 7, 10, and 17
Concentration of cannabinoids will be measured in urine (unit of measurement: nanograms/mL)
Change in Blood cannabinoids
Time frame: Days 1, 2, 3, 7, 10, and 17
Concentration of cannabinoids will be measured in blood (unit of measurement: nanograms/mL)
6 secondary outcomes
Change in Oral fluid cannabinoids
Time frame: Days 1, 2, 3, 7, 10, and 17
Change in Hair cannabinoids
Time frame: Days 1 and 17
Change in Subjective drug effects as assessed by the Drug Effect Questionnaire
Time frame: Days 1, 2, 3, 7, 10, and 17
Change in Cognitive performance as assessed by the Divided Attention Task
Time frame: Days 1, 2, 3, 7, 10, and 17
Change in Working memory performance as assessed by the Paced Serial Addition Task
Time frame: Days 1, 2, 3, 7, 10, and 17
Change in Psychomotor performance as assessed by the Digit Symbol Substitution Task
Time frame: Days 1, 2, 3, 7, 10, and 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 and Drug Effect, 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 12 inclusion and 11 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: finished, as of the sponsor's last update on 10 Mar 2023. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Urine cannabinoids (time frame: Days 1, 2, 3, 7, 10, and 17). The study lists 2 primary outcomes in all. 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 10 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.