Phase
Condition
Carpal Tunnel Syndrome
Treatment
Cannabidiol
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for theduration of the study.
Male or female, aged 18 years or older.
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.
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.
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:
Subject does not speak English.
Subject is blind.
Severe cardiac, pulmonary, liver and /or renal disease.
Coumadin use at time of screening.
History of mental illness.
Subjects who are incarcerated.
History of drug or substance abuse.
Pre-existing CBD or hemp based product usage.
Prior carpal tunnel release surgery or carpal tunnel corticosteroid injection ≤ 6months prior.
History of constant, unremitting numbness or tingling.
History of thenar atrophy.
Patients with severe changes on electrodiagnostic testing.
Patients with a concomitant diagnosis of cervical radiculopathy, peripheralneuropathy, cubital tunnel syndrome, fibromyalgia, chronic regional pain syndrome,or other upper extremity neuropathy
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.
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.
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.