Effect of DrugcannabidiolNCT05456113
Topical Cannabidiol Application and Skin Vascular Reactivity
A study testing Cannabidiol in people with Effect of Drug, run by Penn State University at 1 site in United States.
Trial summary
Cannabidiol, or CBD, is an over-the-counter "nutraceutical" that is more commonly being used by healthy adults for pain management, recovery from strenuous exercise, and general wellness. However, little research exists on the effects of CBD in otherwise healthy individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Effect of Drug
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 1 Oct 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women 18 years of age and older
- English speaking
- Non-obese class III, BMI ≤ 39.9
- Normal HbA1C of <6.5%
Who cannot join
- Abnormal resting heart rate (<60 or >100 bpm) or BP (systolic <100 or >129 mmHg, diastolic <60 or >100 mmHg) values
- Rash, skin disease, disorders of pigmentation
- Known skin allergies
- Diabetes
- Nicotine use (e.g. smoking, chewing tobacco, vaping, etc.)
- Illegal drug use
Show all 9Show fewer
- Recent (within the last 30 days) CBD users either topical or oral
- Allergy or hypersensitivity to investigational agents
- Women who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Noll Laboratory
University Park, Pennsylvania, 16802
About this study
Official title: Cannabidiol and Vascular Reactivity to Skin Sensory Nerve Stimulation
Cannabidiol, or CBD, is an over-the-counter "nutraceutical" that is more commonly being used by healthy adults for pain management, recovery from strenuous exercise, and general wellness. However, little research exists on the effects of CBD in otherwise healthy individuals. This study uses iontophoresis, a common technique used in physical therapy, to determine the effectiveness of topical CBD in lessening the reflex increased cutaneous vascular conductance response to stimulation of the skin.
- Conditions
- Effect of Drug
- Being tested
- Cannabidiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolBiological
Urbal Activ Extra Strength CBD Body Strong Balm applied to region of forearm to be stimulated by iontophoresis machine
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Vehicle control, does not contain cannabidiol Receives: Biological: Cannabidiol |
| Cannabidiol | Experimental | Active ingredient experimental arm, contains full spectrum connabidiol Receives: Biological: Cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous Vascular Conductance
pulse units as measured by laser Doppler flowmetry
Measured: ~5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Dec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- More trials run by Penn State 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lacy Alexander, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456113
- Sponsor's protocol ID
- 20515
- Acronym
- cannabidiol
- Status last verified
- Jan 2025
- First submitted
- 11 Jul 2022
- Last updated
- 17 Jan 2025
- 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 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol and Vascular Reactivity to Skin Sensory Nerve Stimulation
- ClinicalTrials.gov ID
- NCT05456113
- Acronym / sponsor ID
- cannabidiol / 20515
- Conditions
- Effect of Drug
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 13 Jul 2022 (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.
Cannabidiol, or CBD, is an over-the-counter "nutraceutical" that is more commonly being used by healthy adults for pain management, recovery from strenuous exercise, and general wellness. However, little research exists on the effects of CBD in otherwise healthy individuals. This study uses iontophoresis, a common technique used in physical therapy, to determine the effectiveness of topical CBD in lessening the reflex increased cutaneous vascular conductance response to stimulation of the skin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: CannabidiolVehicle control, does not contain cannabidiol |
| Cannabidiol | Experimental | Biological: CannabidiolActive ingredient experimental arm, contains full spectrum connabidiol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women 18 years of age and older
- English speaking
- Non-obese class III, BMI ≤ 39.9
- Normal HbA1C of <6.5%
Key exclusion criteria (9 listed)
- Abnormal resting heart rate (<60 or >100 bpm) or BP (systolic <100 or >129 mmHg, diastolic <60 or >100 mmHg) values
- Rash, skin disease, disorders of pigmentation
- Known skin allergies
- Diabetes
- Nicotine use (e.g. smoking, chewing tobacco, vaping, etc.)
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 |
|---|---|---|
| CannabidiolUrbal Activ Extra Strength CBD Body Strong Balm applied to region of forearm to be stimulated by iontophoresis machine | Biological | Cannabidiol, Placebo |
Primary outcome
Cutaneous Vascular Conductance
Time frame: ~5 hours
pulse units as measured by laser Doppler flowmetry
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabidiol in people with Effect of Drug, run by Penn State 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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 17 Jan 2025. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Cutaneous Vascular Conductance (time frame: ~5 hours). 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 17 Jan 2025.