NCT04611347

Is Topical CBD Effective in Treating Thumb Joint Arthritis

A Randomized Controlled Trial of Topical Cannabidiol for the Treatment of Thumb Basal Joint Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Rationale: CBD is commonly being used as an over-the-counter treatment for arthritis-related pain, however no clinical trial has been performed to establish efficacy. Hypothesis: CBD is more effective than placebo for relieving pain and improving patient-reported outcomes for thumb basal joint arthritis. 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 cream at the thumb base twice daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.

Detailed description

Study Population: 40 subjects with presenting with thumb basal joint arthritis over the age of 18 will be recruited from the UVA Hand Center. Description of Sites/Facilities Enrolling Participants: This will be a single-site study conducted at the UVA Hand Center at the University of Virginia. Description of Study Intervention: The study design will be a double-blind randomized control trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of the case (CBD) or control cream and then crossover to the other cream for 2 more weeks. Patients will apply the topical cream at their thumb basal joint one time daily for 1 hour. The subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. If mild to serious adverse events are noticed, the creams will be removed immediately and appropriate care and observation will be taken. Each condition will last for 2 weeks and then subjects will be contacted by the study coordinator to facilitate crossover into the other condition. To capture any delayed-onset adverse events, including those related to skin changes that might develop after the drug is discontinued, subjects will attend a follow-up visit seven (7) days following the last dose of investigational cream. Study Duration: This study will last one year from the beginning of subject recruitment to data analysis. Participant Duration: Subjects will be enrolled in this study for approximately five (5) weeks from Screening until the final Study Visit.

Conditions

• CBD
• Hand Osteoarthritis

Interventions

Type	Name	Description
DRUG	CBD	Topical CBD application for thumb basal joint osteoarthritis.
DRUG	Shea Butter	Placebo Shae Butter for comparison

Timeline

• Start date: 2020-07-28
• Primary completion: 2021-01-21
• Completion: 2022-05-11
• First posted: 2020-11-02
• Last updated: 2025-07-03
• Results posted: 2025-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study