Topical CBD in Joint Arthritis

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04611347
Study type	Interventional
Source	University of Virginia
Contact	John Heineman, MD, MPH
Phone	641-990-6515
Email	jth4y@virginia.edu
Status	Recruiting
Phase	Phase 2
Start date	November 1, 2020
Completion date	December 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02612233` - Pain Management in Osteoarthritis Using the Centrally Acting Analgesics Duloxetine and Pregabalin	Phase 4
Completed	`NCT01910116` - Efficacy of Shinabro in Hand Osteoarthritis	Phase 2/Phase 3
Completed	`NCT01249391` - Splinting to Treat Hand Osteoarthritis	Phase 2
Recruiting	`NCT04402047` - Electroacupuncture vs Topical Diclofenac Sodium Gel for Patients With Hand Osteoarthritis	N/A
Completed	`NCT03911570` - Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis
Completed	`NCT04576403` - Heated Mittens for Patients With Hand Osteoarthritis	N/A
Completed	`NCT01874067` - C-GLOVES: the Effectiveness of Compression Gloves in Arthritis
Completed	`NCT02528630` - Progressive Strength in Hand Osteoarthritis	Phase 4
Suspended	`NCT03703934` - Central Pain Mechanisms in Patients With Hand-Osteoarthritis, Psoriatic Arthritis and Healthy Controls
Completed	`NCT04585113` - Diagnostic Accuracy of Dual-energy CT
Completed	`NCT05568875` - Happy Hands - an E-self-management Intervention for People With Hand Osteoarthritis	N/A
Completed	`NCT03693833` - CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis.	Phase 2
Completed	`NCT05150171` - Happy Hands E-self-management Pilot Study	N/A
Completed	`NCT02667145` - Assistive Device for Hand Osteoarthritis	N/A
Completed	`NCT02477059` - Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Patients With Hand Osteoarthritis	Phase 3
Completed	`NCT04036929` - Can we Use Estrogen-containing Therapy to Improve Pain in Women After Menopause With Hand Osteoarthritis?	N/A
Completed	`NCT03919279` - Treatment of Erosive Digital Osteoarthritis by Transcutaneous Auricular Nerve Stimulation	N/A
Recruiting	`NCT06329219` - Water-filtered Infrared-A Radiation in Patients With Hand Osteoarthritis	N/A
Not yet recruiting	`NCT05216757` - Efficacy and Safety of Iguratimod in Patients With Hand Osteoarthritis (ESIGO)	Phase 2/Phase 3
Completed	`NCT02771860` - RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.