Topical CBD for Musculoskeletal Pain

NCT05170451 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: HSR200170
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (3)

• Number of participants with change in The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) during intervention and at follow-up.

  PROMIS-29 will measure health-related quality of life and is a validated, 29 question survey divided into seven sub-domains of function including physical functioning, social function, pain interference, pain intensity, sleep, depression, and anxiety, where a higher score indicates more pain interference.

  [Time Frame: Every 1 week during intervention and 1 week washout, up to 7 weeks.]

• Change from baseline in Visual Analog Pain (VAS) Score during intervention and at follow-up.

  The VAS score is a unidimensional measure of pain intensity and is a validated, subjective measure for acute and chronic pain. A patient is asked to indicate his/her perceived pain intensity along a horizontal line (from 0 to 100), and this rating is then measured from the left edge with higher numbers indicating more pain.

  [Time Frame: Every 1 week during intervention and 1 week washout, up to 7 weeks.]

• Change from baseline in Single Assessment Numerical Evaluation (SANE)

  The SANE score is a validated metric for musculoskeletal pain which can be applied to any joint or region of interest. The patient is asked to rate his/her pain from 0-100. Patients rate their current illness score in relation to their pre-injury baseline.

  [Time Frame: Every 1 week during intervention and 1 week washout, up to 7 weeks.]

Secondary Outcomes (1)

• Rate of side effects using novel CBD cream.

  [Time Frame: Daily during intervention and 1 week washout, up to 7 weeks.]

Study Arms (2)

Active Comparator: Start with CBD

ACTIVE COMPARATOR

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 and then crossover to the other condition (Shea butter only) for 2 additional weeks. Patients will apply the topical cream to the affected body region or joint two times daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.

Drug: CBD; Other: Control

Active Comparator: Start with control (Shea butter)

ACTIVE COMPARATOR

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 Shea butter and then crossover to the other condition (CBD) for 2 additional weeks. Patients will apply the topical cream to the affected body region or joint two times daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.

Drug: CBD; Other: Control

Interventions

CBD DRUG

Topical CBD 50 mg/ml applied in 1mL amounts twice daily

Active Comparator: Start with CBD; Active Comparator: Start with control (Shea butter)

Control OTHER

Topical shea butter applied in 1mL amounts twice daily

Also known as: Shea butter

Active Comparator: Start with CBD; Active Comparator: Start with control (Shea butter)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged 18 years or older.
• Females of childbearing potential must have a negative urine and blood pregnancy test at 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 during the period from Screening to administration of study drug and for 30 days after the last dose of study medication. Standard acceptable methods include abstinence or the use 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 be post-menopausal defined as: age \> 55 with no menses within the past 12 months, or history of hysterectomy, or history of bilateral oophorectomy, or bilateral tubal ligation.
• Males must consent to use a medically acceptable method of contraception throughout the 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 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-related pain, or fibromyalgia or physician-diagnosed postoperative pain in a discrete body region.

You may not qualify if:

• 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 childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined 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 include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom with spermicide, vasectomy, intrauterine device.
• Any skin disease or condition, including eczema, psoriasis, melanoma, acne or contact dermatitis, scarring, imperfections, lesions, tattoos or discoloration that may affect treatment application, application site assessments, or affect absorption of the study drug.
• Subjects with ALT/AST \>3 times the upper limit of normal at screening.
• Subjects with history of or active depression or suicide ideation based on Columbia-Suicide Severity Rating Scale (C-SSRS).
• Subjects taking prescription or non-prescription medication which are substrates of CYP3A4 (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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brent DeGeorge, MD, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Plastic Surgery

Model Details: Randomized controlled trial with crossover

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 28, 2021
• Study Start: January 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)