cannabidiol: Topical Cannabidiol Application and Skin Vascular Reactivity

Sponsor

Penn State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05456113

Collaborator

(none)

Enrollment

Arms

2.1

Anticipated Duration (Months)

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Effect of Drug	Biological: Cannabidiol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Cannabidiol and Vascular Reactivity to Skin Sensory Nerve Stimulation

Anticipated Study Start Date :

Jul 30, 2022

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Vehicle control, does not contain cannabidiol	Biological: Cannabidiol Urbal Activ Extra Strength CBD Body Strong Balm applied to region of forearm to be stimulated by iontophoresis machine
Experimental: Cannabidiol Active ingredient experimental arm, contains full spectrum connabidiol	Biological: Cannabidiol Urbal Activ Extra Strength CBD Body Strong Balm applied to region of forearm to be stimulated by iontophoresis machine

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Vehicle control, does not contain cannabidiol

Biological: Cannabidiol

Urbal Activ Extra Strength CBD Body Strong Balm applied to region of forearm to be stimulated by iontophoresis machine

Experimental: Cannabidiol

Active ingredient experimental arm, contains full spectrum connabidiol

Biological: Cannabidiol

Urbal Activ Extra Strength CBD Body Strong Balm applied to region of forearm to be stimulated by iontophoresis machine

Outcome Measures

Primary Outcome Measures

Cutaneous Vascular Conductance [~5 hours]
pulse units as measured by laser Doppler flowmetry

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Men and women 18 years of age and older
English speaking
Non-obese class III, BMI ≤ 39.9
Normal HbA1C of <6.5%

Exclusion Criteria:

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
Recent (within the last 30 days) CBD users either topical or oral
Allergy or hypersensitivity to investigational agents
Women who are pregnant or breastfeeding

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Penn State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lacy Alexander, Professor of Kinesiology, Penn State University

ClinicalTrials.gov Identifier:

NCT05456113

Other Study ID Numbers:

20515

First Posted:

Jul 13, 2022

Last Update Posted:

Jul 14, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Cannabidiol

Study Results

No Results Posted as of Jul 14, 2022