Topical Cannabidiol for Treating Carpal Tunnel Syndrome

Last updated: April 8, 2025
Sponsor: University of Virginia
Overall Status: Active - Not Recruiting

Phase

2

Condition

Carpal Tunnel Syndrome

Treatment

Cannabidiol

Clinical Study ID

NCT06108349
HSR230375
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The Purpose of this study is to assess the safety and efficacy of Cannabidiol on treatment of Carpal Tunnel Syndrome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision of signed and dated informed consent form.

  2. Stated willingness to comply with all study procedures and availability for theduration of the study.

  3. Male or female, aged 18 years or older.

  4. Females of childbearing potential must have a negative urine and blood pregnancytest at Screening and a negative urine pregnancy test before study drug isadministered. Females must abstain from sex or use a highly effective method ofcontraception during the period from Screening to administration of study drug andfor 30 days after the last dose of study medication. Standard acceptable methodsinclude abstinence or the use of a highly effective method of contraception,including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condomwith spermicide, vasectomy, intrauterine device. If females are of non-child bearingpotential, they must be post-menopausal defined as: age > 55 with no menses withinthe past 12 months, or history of hysterectomy, or history of bilateraloophorectomy, or bilateral tubal ligation.

  5. Males must consent to use a medically acceptable method of contraception throughoutthe 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 drugapplication.

  6. Presence of clinical diagnosis of carpal tunnel syndrome with a CTS-6 score greaterthan 12 who have undergone electrodiagnostic testing with mild to moderate carpaltunnel syndrome

Exclusion

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 ≤ 6months 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, peripheralneuropathy, 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 childbearingpotential who are unwilling or unable to use an acceptable method of contraceptionas outlined in this protocol from Screening to the first dose of study medicationand for 30 days after the last dose of study medication. Standard acceptable methodsinclude abstinence or the use of a highly effective method of contraception,including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condomwith spermicide, vasectomy, intrauterine device.

  15. Any skin disease or condition, including eczema, psoriasis, melanoma, acne orcontact dermatitis, scarring, imperfections, lesions, tattoos or discoloration thatmay affect treatment application, application site assessments, or affect absorptionof the study drug.

  16. Subjects taking prescription or non-prescription medication which are substrates ofCYP3A4 (Itraconazole, Ketoconazole, Azamulin, Troleandomycin, Verapamil, John'swart, 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.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Cannabidiol
Phase: 2
Study Start date:
July 01, 2025
Estimated Completion Date:
January 01, 2027

Study Description

Carpal tunnel syndrome (CTS), or compression neuropathy of the median nerve at the wrist, is the most common entrapment neuropathy affecting up to 15% of the general population Non-operative interventions for CTS include night-time splinting, physical therapy, and corticosteroid administration, however only surgery is considered a definitive treatment for CTS. There is an unmet need for novel, effective non-operative options for the treatment of CTS to provide care for patients who cannot undergo surgery for medical reasons or do not feel comfortable proceeding with a surgical option.

Cannabidiol (CBD) is a non-psychoactive minor cannabinoid component of Cannabis sativa that is emerging as a treatment to mitigate pain, numbness, and tingling associated with peripheral neuropathy. Pre-clinical data indicates that CBD acts through multiple receptors to modulate central and peripheral neuropathic signaling pathways to alleviate pain - specifically in pre-clinical models of compression neuropathy as in CTS. This pilot trial seeks to investigate whether CBD is a safe, feasible, and effective treatment for CTS in patients with confirmed mild to moderate CTS receiving standardized physiotherapy with primary endpoints assessing feasibility, symptom severity, and/or disability and also highlights the gap in knowledge regarding the clinical utility of cannabinoids