Last updated: October 30, 2020
Sponsor: University of Virginia
Overall Status: Active - Recruiting
Phase
2
Condition
Osteoarthritis
Joint Injuries
Progressive Supranuclear Palsy
Treatment
N/AClinical Study ID
NCT04611347
HSR200147
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of thefollowing 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 pregnancy testat 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 duringthe period from Screening to administration of study drug and for 30 days after thelast dose of study medication. Standard acceptable methods include abstinence or theuse 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 bepost-menopausal defined as: age > 55 with no menses within the past 12 months, orhistory of hysterectomy, or history of bilateral oophorectomy, or bilateral tuballigation.
- 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. Theymust agree to not donate sperm for 90 days after their last study drug application.
- Presence of radiographically confirmed diagnosis of thumb basal joint arthritis.
Exclusion
Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participationin this study:
- Subject does not speak English.
- Severe cardiac, pulmonary, liver and /or renal disease.
- Coumadin use at time of screening.
- History of mental illness.
- Pregnancy or breast feeding at time of screening.
- Subjects who are incarcerated.
- History of drug or substance abuse.
- Pre-existing CBD or hemp based product usage.
- Subject has had a corticosteroid injection ≤ 3 months prior.
- Subject has had prior surgery for osteoarthritis treatment.
- Females who are pregnant, nursing or planning a pregnancy; females of childbearingpotential who are unwilling or unable to use an acceptable method of contraception asoutlined 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 includeabstinence or the use of a highly effective method of contraception, including;hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom withspermicide, vasectomy, intrauterine device.
- Any skin disease or condition, including eczema, psoriasis, melanoma, acne or contactdermatitis, scarring, imperfections, lesions, tattoos or discoloration that may affecttreatment application, application site assessments, or affect absorption of the studydrug.
- Subjects with ALT/AST >3 times the upper limit of normal at screening.
- Subjects with history of or active depression or suicide ideation based onColumbia-Suicide Severity Rating Scale (C-SSRS).
- Subjects taking prescription or non-prescription medication which are substrates ofCYP3A4, CYP2C19, CYP2C8, CYP2C9, CYP2C19, CYP1A2 and CYP2B6 within 14 days of thestudy procedure.
Study Design
Total Participants: 40
Study Start date:
November 01, 2020
Estimated Completion Date:
December 31, 2021
Study Description
Connect with a study center
University of Virginia
Charlottesville, Virginia 22903
United StatesActive - Recruiting
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