Is Topical CBD Effective in Treating Thumb Joint Arthritis

NCT04611347 | Completed Phase 2 Results FDA Drug

• 1 other identifier: HSR200147
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CBD; Hand Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• Change in Hand Strength During Intervention and at Follow-up.

  Grip strength, kg.

  Change from baseline to 2 weeks

• Change in the PROMIS Upper Extremity Tests During Intervention and at Follow-up.

  The Patient Reported Outcome Information System (PROMIS) Upper Extremity Computer Adaptive Test (CAT) is a computerized assessment measuring the physical function of the upper extremity. It is scored using a T-score, and the average is 50 for the U.S. population. In a given PROMIS, a T-score above 50 represents more of the measured variable than the average. For this variable, a T-score above 50 indicates greater physical function than the average population.

  Change from baseline to 2 weeks

• Change in Kapandji Score

  Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.

  Change from baseline to 2 weeks

• Change in Hand Range of Motion

  Metacarpal phalangeal (MP) range of motion, passive extension.

  Change from baseline to 2 weeks

Secondary Outcomes (1)

• Rate of Side Effects Using Novel CBD Cream.

  Change from baseline to 2 weeks

Study Arms (2)

Start with CBD

ACTIVE COMPARATOR

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 and then crossover to the other condition (Shea butter only ) 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.

Drug: CBD; Drug: Shea Butter

Start with control (Shea butter)

ACTIVE COMPARATOR

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 Shea butter and then crossover to the other condition (CBD)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.

Drug: CBD; Drug: Shea Butter

Interventions

CBD DRUG

Topical CBD application for thumb basal joint osteoarthritis.

Start with CBD; Start with control (Shea butter)

Shea Butter DRUG

Placebo Shae Butter for comparison

Start with CBD; Start with control (Shea butter)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged 18 years or older.
• Females of childbearing potential must have a negative urine and blood pregnancy test at Screening and a negative urine pregnancy test before study drug is administered. Females must abstain from sex or use a highly effective method of contraception during the period from Screening to administration of study drug and for 30 days after the last dose of study medication. Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom with spermicide, vasectomy, intrauterine device. If females are of non-child bearing potential, they must be post-menopausal defined as: age \> 55 with no menses within the past 12 months, or history of hysterectomy, or history of bilateral oophorectomy, or bilateral tubal ligation.
• Males must consent to use a medically acceptable method of contraception throughout the entire study period and for 90 days after their last study drug application. They must agree to not donate sperm for 90 days after their last study drug application.
• Presence of radiographically confirmed diagnosis of thumb basal joint arthritis.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Subject does not speak English.
• Severe cardiac, pulmonary, liver and /or renal disease.
• Coumadin use at time of screening.
• History of mental illness.
• Pregnancy or breast feeding at time of screening.
• Subjects who are incarcerated.
• History of drug or substance abuse.
• Pre-existing CBD or hemp based product usage.
• Subject has had a corticosteroid injection ≤ 3 months prior.
• Subject has had prior surgery for osteoarthritis treatment.
• Females who are pregnant, nursing or planning a pregnancy; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from Screening to the first dose of study medication and for 30 days after the last dose of study medication. Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom with spermicide, vasectomy, intrauterine device.
• Any skin disease or condition, including eczema, psoriasis, melanoma, acne or contact dermatitis, scarring, imperfections, lesions, tattoos or discoloration that may affect treatment application, application site assessments, or affect absorption of the study drug.
• Subjects with ALT/AST \>3 times the upper limit of normal at screening.
• Subjects with history of or active depression or suicide ideation based on Columbia-Suicide Severity Rating Scale (C-SSRS).

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Results Point of Contact

• Title: Brent DeGeorge, MD
• Organization: University of Virginia

BD6U@uvahealth.org

434.982.4263

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial with crossover

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: November 2, 2020
• Study Start: July 28, 2020
• Primary Completion: January 21, 2021
• Study Completion: May 11, 2022
• Last Updated: July 3, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)