NCT05456113

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
5mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Dec 2024Oct 2026

First Submitted

Initial submission to the registry

July 11, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
2.4 years until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

July 11, 2022

Last Update Submit

January 15, 2025

Conditions

Effect of Drug

Outcome Measures

Primary Outcomes (1)

  • Cutaneous Vascular Conductance

    pulse units as measured by laser Doppler flowmetry

    ~5 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Vehicle control, does not contain cannabidiol

Biological: Cannabidiol

Cannabidiol

EXPERIMENTAL

Active ingredient experimental arm, contains full spectrum connabidiol

Biological: Cannabidiol

Interventions

CannabidiolBIOLOGICAL

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

CannabidiolPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Noll Laboratory

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Kinesiology

Study Record Dates

First Submitted

July 11, 2022

First Posted

July 13, 2022

Study Start

December 1, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

October 1, 2026

Last Updated

January 17, 2025

Record last verified: 2025-01

Locations

US(1)