Topical CBD for Musculoskeletal Pain

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

Rationale: CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain; however, no clinical trial has been performed to establish efficacy of CBD in humans for musculoskeletal pain.

Hypothesis: CBD is more effective than placebo for relieving pain and improving patient-reported outcomes for musculoskeletal pain.

Study Design: The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of the CBD or control and then crossover to the other condition for 2 additional weeks. Patients will apply the CBD or control cream to the affected area twice daily (approximately every 12 hours) for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.

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 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.
  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. Theymust agree to not donate sperm for 90 days after their last study drug application.
  6. 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:

  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. Subject has had a corticosteroid injection ≤ 3 months prior.
  10. Subject has had prior surgery for osteoarthritis treatment.
  11. 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.
  12. 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.
  13. Subjects with ALT/AST >3 times the upper limit of normal at screening.
  14. Subjects with history of or active depression or suicide ideation based onColumbia-Suicide Severity Rating Scale (C-SSRS).
  15. 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

Study Population: 100 subjects presenting with musculoskeletal pain over the age of 18 will be recruited from the University of Virginia from the Hand Center or Primary Care Clinic.

Description of Sites/Facilities Enrolling Participants: This will be a single-site study conducted at the University of Virginia in the Hand Center and the Primary Care Clinic.

Description of Study Intervention: The study design will be a double-blind randomized control trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of the case (CBD) or control cream and then crossover to the other cream for 2 more weeks with a 1-week washout interval between. Patients will apply the topical cream to the affected body region or joint two times daily for 1 hour. The subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. If mild to severe adverse events are noticed, the creams will be removed immediately, and appropriate care and observation will be taken. Each condition will last for 2 weeks and then subjects will be contacted by the study coordinator to facilitate crossover into the other condition following a 1-week washout period. To capture any delayed-onset adverse events, including those related to skin changes that might develop after the drug is discontinued, subjects will attend a follow-up visit seven days following the last dose of investigational cream.

Study Duration: This study will last one year from the beginning of subject recruitment to data analysis.

Participant Duration: Subjects will be enrolled in this study for approximately seven (7) weeks from Screening until the final Study Visit.

Connect with a study center

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

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