CompletedNCT04741477Updated Mar 10, 2023

The Pharmacokinetics and Pharmacodynamics of Hemp-based Topical Cannabinoid Products

A Phase 1 interventional study of CBD and THC in Cannabis and Drug Effect, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-10.

Sponsored by Johns Hopkins University · Phase 1, Interventional, and Basic science

From the registry’s dates

Primary completion was Sep 2022, 4 years 1 month ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 47
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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 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 studied

Cannabis
Drug Effect

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Marijuana Abuse 530

In context

Marijuana Abuse

530 studies on the registry are indexed under Marijuana Abuse; 114 are open to participants now.

This study's enrollment of 47 is below the median of 60 across 431 interventional studies indexed under Marijuana Abuse.

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Lead sponsor

Johns Hopkins University is the lead sponsor of 1,809 studies on the registry; 314 are open to participants now.

Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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.
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.

Exclusion criteria

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.
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.
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.

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 47 participants (actual)

Study 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.
Drug: CBD · Drug: THC
Placebo comparator
Placebo topical product
Participants will topically apply a placebo product that does not contain cannabinoids.
Drug: Placebo

Interventions

DrugCBD
CBD will be topically applied
DrugTHC
THC will be topically applied
DrugPlacebo
a placebo product (without cannabinoids) will be topically applied

What researchers measure

Primary outcomes

Change in Urine cannabinoids
Concentration of cannabinoids will be measured in urine (unit of measurement: nanograms/mL)
Time frame: 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)
Time frame: Days 1, 2, 3, 7, 10, and 17

Secondary outcomes

Change in Oral fluid cannabinoids
Concentration of cannabinoids will be measured in oral fluid (unit of measurement: nanograms/mL)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Days 1, 2, 3, 7, 10, and 17

Study locations

1 site

Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland 21224, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2021 to primary completion in Sep 2022, 14 months.

Of 51 non-industry phase 1 interventional studies under Marijuana Abuse, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 46. This study's 14 months is below that.

Counting every sponsor, half of 55 studies reached it within 27 months; a quarter within 12 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 2, 2021
First posted: Feb 5, 2021
StartActual: Jul 14, 2021
Primary completionActual: Sep 16, 2022
CompletionActual: Sep 16, 2022
Last update: Mar 10, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04741477
Lead sponsor: Johns Hopkins University
Collaborators: Substance Abuse and Mental Health Services Administration (SAMHSA)
Responsible party: Sponsor
First posted: Feb 5, 2021
Start date: Jul 14, 2021
Primary completion: Sep 16, 2022
Completion: Sep 16, 2022
Last update: Mar 10, 2023

Study contacts

Tory Spindle, PhD

principal investigator · Johns Hopkins University

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Cannabidiol · Dronabinol

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