Topical CBD for treating thumb arthritis pain

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

This study is testing if a CBD cream can help relieve pain for people with thumb arthritis better than a regular cream.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Virginia (other)
• Locations: 1 site (Charlottesville, Virginia)
• Trial ID: NCT04611347 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of topical CBD cream in relieving pain and improving outcomes for patients with thumb basal joint arthritis. It employs a double-blind, randomized controlled design with a crossover approach, where participants will receive either CBD or a control cream for two weeks before switching to the other treatment for an additional two weeks. Participants will apply the cream twice daily and report any physiological or skin changes during the study. The trial aims to establish whether CBD is more effective than placebo in managing arthritis-related pain.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with thumb basal joint arthritis.

Not a fit: Patients with conditions unrelated to thumb arthritis or those who are not able to comply with study procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new, effective topical treatment option for patients suffering from thumb arthritis.

How similar studies have performed: While CBD is widely used for arthritis pain relief, this is one of the first clinical trials specifically evaluating its efficacy in this context.

Eligibility criteria

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, aged 18 years or older.
4. 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.
5. 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.
6. Presence of radiographically confirmed diagnosis of thumb basal joint arthritis.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Subject does not speak English.
2. Severe cardiac, pulmonary, liver and /or renal disease.
3. Coumadin use at time of screening.
4. History of mental illness.
5. Pregnancy or breast feeding at time of screening.
6. Subjects who are incarcerated.
7. History of drug or substance abuse.
8. Pre-existing CBD or hemp based product usage.
9. Subject has had a corticosteroid injection ≤ 3 months prior.
10. Subject has had prior surgery for osteoarthritis treatment.
11. 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.
12. 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.
13. Subjects with ALT/AST \>3 times the upper limit of normal at screening.
14. Subjects with history of or active depression or suicide ideation based on Columbia-Suicide Severity Rating Scale (C-SSRS).
15. Subjects taking prescription or non-prescription medication which are substrates of CYP3A4, CYP2C19, CYP2C8, CYP2C9, CYP2C19, CYP1A2 and CYP2B6 within 14 days of the study procedure.

Where this trial is running

Charlottesville, Virginia

• University of Virginia — Charlottesville, Virginia, United States (RECRUITING)

Study contacts

• Study coordinator: John Heineman, MD, MPH

Conditions: CBD, Hand Osteoarthritis