Topical CBD in Joint Arthritis

Launched by UNIVERSITY OF VIRGINIA · Oct 30, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a topical cream containing CBD (cannabidiol) on pain relief for people with thumb basal joint arthritis, which is a type of arthritis affecting the joint at the base of the thumb. The researchers want to find out if CBD can help reduce pain and improve overall well-being compared to a placebo, which is an inactive cream. The trial will take place in two phases, where participants will use either the CBD cream or the placebo for two weeks before switching to the other treatment for another two weeks. Participants will apply the cream twice daily and will be monitored for any changes or side effects.

To participate, individuals must be at least 18 years old and have a confirmed diagnosis of thumb basal joint arthritis. Women who can become pregnant need to meet certain requirements regarding pregnancy testing and contraception. Participants should not have severe health issues, such as serious heart or liver disease, and should not be using certain medications that could interfere with the study. The trial is currently recruiting participants and offers a chance to explore a potential new treatment for arthritis pain.

Gender

ALL

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.