Clinical trial

Cannabidiol and Vascular Reactivity to Skin Sensory Nerve Stimulation

Name
20515
Description
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.
Trial arms
Trial start
2024-12-01
Estimated PCD
2025-12-31
Trial end
2026-10-01
Treatment
Cannabidiol
Urbal Activ Extra Strength CBD Body Strong Balm applied to region of forearm to be stimulated by iontophoresis machine
Arms:
Cannabidiol, Placebo
Size
48
Primary endpoint
Cutaneous Vascular Conductance
~5 hours
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}
Updated at
2023-11-01

1 organization

1 drug

1 indication

Indication
Drug Effect