Topical CBD for Musculoskeletal Pain
NCT05170451 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL
Last updated 2024-02-28
Summary
Rationale: CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain; however, no clinical trial has been performed to establish efficacy of CBD in humans for musculoskeletal pain.
Hypothesis: CBD is more effective than placebo for relieving pain and improving patient-reported outcomes for musculoskeletal pain.
Study Design: The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of the CBD or control and then crossover to the other condition for 2 additional weeks. Patients will apply the CBD or control cream to the affected area twice daily (approximately every 12 hours) for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.
Conditions
Interventions
- DRUG
-
CBD
Topical CBD 50 mg/ml applied in 1mL amounts twice daily
- OTHER
-
Control
Topical shea butter applied in 1mL amounts twice daily
Sponsors & Collaborators
-
University of Virginia
lead OTHER
Principal Investigators
-
Brent DeGeorge, MD, PhD · University of Virginia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-31
- Primary Completion
- 2022-06-30
- Completion
- 2022-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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