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Search / Trial NCT06108349

Topical Cannabidiol for Treating Carpal Tunnel Syndrome

Launched by UNIVERSITY OF VIRGINIA · Oct 24, 2023

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Distal Median Nerve Compression Entrapment Neuropathy

ClinConnect Summary

This clinical trial is looking at a treatment for Carpal Tunnel Syndrome (CTS) using Cannabidiol, a compound found in cannabis. The study aims to determine if Cannabidiol is safe and effective for people suffering from CTS, a condition that causes pain and tingling in the hands due to pressure on the nerves in the wrist. The trial is not yet recruiting participants, but it will include men and women aged 18 and older who have a confirmed diagnosis of mild to moderate carpal tunnel syndrome.

To participate, individuals will need to provide consent and be willing to follow the study's guidelines. Women who can become pregnant must test negative for pregnancy and agree to use effective contraception during the study. Participants will apply the Cannabidiol treatment topically and will be monitored for safety and effectiveness. It's important to note that some people may not be eligible, including those with certain medical conditions or those who have had recent treatments for carpal tunnel syndrome. If you're interested in participating, keep an eye out for when the study starts recruiting!

Gender

ALL

Eligibility criteria

  • Inclusion 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 clinical diagnosis of carpal tunnel syndrome with a CTS-6 score greater than 12 who have undergone electrodiagnostic testing with mild to moderate carpal tunnel syndrome
  • Exclusion Criteria:
  • 1. Subject does not speak English.
  • 2. Subject is blind.
  • 3. Severe cardiac, pulmonary, liver and /or renal disease.
  • 4. Coumadin use at time of screening.
  • 5. History of mental illness.
  • 6. Subjects who are incarcerated.
  • 7. History of drug or substance abuse.
  • 8. Pre-existing CBD or hemp based product usage.
  • 9. Prior carpal tunnel release surgery or carpal tunnel corticosteroid injection ≤ 6 months prior.
  • 10. History of constant, unremitting numbness or tingling.
  • 11. History of thenar atrophy.
  • 12. Patients with severe changes on electrodiagnostic testing.
  • 13. Patients with a concomitant diagnosis of cervical radiculopathy, peripheral neuropathy, cubital tunnel syndrome, fibromyalgia, chronic regional pain syndrome, or other upper extremity neuropathy
  • 14. 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.
  • 15. 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.
  • 16. Subjects taking prescription or non-prescription medication which are substrates of CYP3A4 (Itraconazole, Ketoconazole, Azamulin, Troleandomycin, Verapamil, John's wart, Phenobarbital), CYP2C19 (Nootkatone, Ticlopidine, Rifampin, Omeprazole), CYP2C8 (Montelukast, Quercetin, Phenelzine, Rifampin, Clopidogrel) , CYP2C9 (Sulfaphenazole, Tienilic acid, Carbamazepine, Apalutamide, Fluconazole, Celecoxib), CYP1A2 (alpha-Naphthoflavone, Furafylline, Phenytoin, Rifampin, Ritonavir, smoking, Teriflunomide, Ciproflaoxacin, oral contraceptives, Alloprinol) and CYP2B6 (Sertraline, Phencyclidine, Thiotepa, Ticlopidine, Carbamazepine, Efavirenez, Rifampin, Bupropion) within 14 days of the study procedure.

About University Of Virginia

The University of Virginia (UVA) is a prestigious academic institution renowned for its commitment to advancing medical research and improving patient care through innovative clinical trials. With a focus on interdisciplinary collaboration, UVA leverages its extensive resources and expertise in various fields, including medicine, engineering, and public health, to drive cutting-edge studies that address pressing health challenges. The university's clinical trial programs aim to translate scientific discoveries into effective treatments, ensuring the highest standards of ethical practice and participant safety. Through its strong emphasis on community engagement and education, UVA fosters a culture of research that not only contributes to the scientific community but also enhances the well-being of the populations it serves.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported