Last updated: February 23, 2024
Sponsor: University of Virginia
Overall Status: Trial Not Available
Phase
2/3
Condition
Muscle Pain
Chronic Pain
Acute Pain
Treatment
CBD
Control
Clinical Study ID
NCT05170451
HSR200170
Ages > 18 All Genders
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 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 physician-diagnosed musculoskeletal pain in a discrete body region,including bone or joint-related pain, tendon or ligament-related pain, muscle-relatedpain, or fibromyalgia or physician-diagnosed postoperative pain in a discrete bodyregion.
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.
- 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 (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.
Study Design
Treatment Group(s): 2
Primary Treatment: CBD
Phase: 2/3
Study Start date:
January 01, 2022
Estimated Completion Date:
December 31, 2022
Study Description
Connect with a study center
University of Virginia
Charlottesville, Virginia 22903
United StatesSite Not Available
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