A Randomized Controlled Trial of Oral CBD for the Treatment of Upper Extremity Musculoskeletal Pain

Phase 1Not Yet RecruitingNCT06695195

Brent DeGeorge100 enrolled

Overview

The goal of this clinical trial is to learn about the use of cannabidiol (CBD) capsules as a treatment for musculoskeletal pain. CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for hand and wrist osteoarthritis with topical CBD, however patients prefer oral CBD and no clinical trial has been performed to establish efficacy of oral CBD in humans for upper extremity musculoskeletal pain. The main questions it aims to answer are: Is CBD more effective than placebo at relieving pain for upper extremity musculoskeletal pain ? Is CBD safe for participants with upper extremity musculoskeletal pain? Participants will: take 4 weeks of daily CBD capsules take 4 weeks of daily placebo capsules answer surveys about how they are feeling and functioning. Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

This randomized controlled trial of CBD will investigate the therapeutic potential of CBD as an oral treatment for the treatment of pain of upper extremity musculoskeletal pain. Rationale: CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for hand and wrist osteoarthritis with topical CBD, however patients prefer oral CBD and no clinical trial has been performed to establish efficacy of oral CBD in humans for upper extremity musculoskeletal pain. Hypothesis: CBD is more effective than placebo for relieving pain and improving patient-reported outcomes for upper extremity musculoskeletal pain. Study Design: The study design will be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 4 weeks of the CBD or control and then crossover to the other condition for 4 additional weeks. Patients will take one oral capsule twice daily, once in the morning and once in the evening. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male or female, aged 18 years or older. 4. Daily visual analog pain score \>5/10 and \<9/10. 5. Duration of pain for greater than or equal to 3 months. 6. Presence of physician-diagnosed musculoskeletal pain in the upper extremities, 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, limited to upper extremities. 7. For females, must be willing to use an approved form of birth control during this study. Acceptable forms of birth control: * Norplant * Sterilization * IUD (intrauterine device) * Birth Control Patch * Depo-Provera The following may be used if combined with other birth control methods: * Condoms * Diaphragm * Jellies or foam * Sponge * Cervical cap 8. For males, must be willing to not father a baby for the duration of the study and for 90 days after the last dose of study drug, or donate to a sperm bank during this time. Must be willing to use an approved form of birth control during this time. Acceptable forms of birth control: * Condoms * Sterilization Exclusion Criteria: 1. Subject does not speak or read English fluently. 2. Subject is blind. 3. Severe cardiac, pulmonary, liver and /or renal disease, or any other major organ dysfunction. 4. Subject with a history of symptoms (e.g., dizziness, light-headedness, blurred vision, palpitations, weakness, syncope) related to a drop in blood pressure due to postural changes. 5. Coumadin use at time of screening. 6. History of mental illness. 7. Subjects who are incarcerated. 8. Subjects who satisfy any DSM-V criteria for current psychiatric illness such as bipolar disorder, depression, anxiety, schizophrenia, psychosis, substance use disorder or any other psychiatric diagnosis 9. Subjects who have used intra-articular corticosteroids 30 days prior to screening. 10. History of drug or substance abuse. 11. Pre-existing CBD product usage currently (or within the prior 3 months) using recreational or medicinal cannabis, any cannabinoid-based medications, and is unwilling to abstain for the duration of the study. 12. Subject has had a corticosteroid injection ≤ 60 days prior. 13. Subjects who are unwilling to agree to no opioid medications or topical analgesic medications during the study period. 14. Any woman of child bearing potential or male patient's partner unwilling to ensure that they or their partner use effective contraception, for example, hormonal contraception, double barrier, intra-uterine device, during the study and for females, through 30 days thereafter, and for males, three months thereafter. 15. Any male not willing to avoid donating sperm during the duration of the study treatment period and for three months thereafter. 16. Any patient with aberrant liver function as defined by either of the following: * ALT \>5x ULN or total bilirubin\>2×ULN * ALT or AST\>3 × ULN and total bilirubin\>2xULN or INR \>1.5 17. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP3A4 : * Itraconazole, * Ketoconazole, * Azamulin, * Troleandomycin, * Verapamil, * John's wart, * Phenobarbital, 18. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2C19: * Nootkatone, * Ticlopidine, * Rifampin, * Omeprazole), 19. Subjects taking prescription or non-prescription medication which are substrates of CYP2C8: * Montelukast, * Quercetin, * Phenelzine, * Rifampin, * Clopidogrel) , 20. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates ofCYP2C9: * Sulfaphenazole, * Tienilic acid, * Carbamazepine, * Apalutamide, * Fluconazole, * Celecoxib 21. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP1A2: * alpha-Naphthoflavone, * Furafylline, * Phenytoin, * Rifampin, * Ritonavir, * smoking, * Teriflunomide, * Ciproflaoxacin, * oral contraceptives, * Allopurinol 22. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2B6: * Sertraline, * Phencyclidine, * Thiotepa, * Ticlopidine, * Carbamazepine, * Efavirenez, * Rifampin, * Bupropion.

Outcomes

Primary Outcomes

Change from Baseline in Pain on the Visual Analog Pain (VAS) Score

The Visual Analog Pain (VAS) Score is a validated, self-reported subjective measure for measuring acute and chronic pain. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change = (Week (4 or 6) Score - Baseline Score).a validated, self-report

Time frame: Baseline and Week 4, Week 6

Change from Baseline in Pain on the Visual Analog Pain (VAS) Score - Crossover Condition

Time frame: Baseline and Week 4, Week 6

Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score

The SANE Score is a self-reported subjective measure for measuring percentage of normal function. Possible scores range from 0 (most abnormal) to 100 (normal). Change = (Week (4 or 6) Score - Baseline Score)

Time frame: Baseline and Week 4, Week 6

Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score - Crossover Condition

Time frame: Baseline and Week 4, Week 6

Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score

The PROMIS Global Health-10 is a validated, self-reported subjective measure for measuring generic health related quality of life. Possible scores range from 0 (most severe impairment) to 20 (best health). Change = (Week (4 or 6) Score - Baseline Score)

Time frame: Baseline and Week 4, Week 6

Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score - Crossover Condition

Time frame: Baseline and Week 4, Week 6

Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score

The PROMIS Pain Interference is a validated, self-reported subjective measure for measuring generic health related quality of life. Possible scores range from 0 (does not interfere) to 10 (completely interferes). Change = (Week (4, 6) Score - Baseline Score)

Time frame: Baseline and Week 4, Week 6

Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score - Crossover Condition

Time frame: Baseline and Week 4, Week 6

Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score

The PROMIS UE computer adaptive test is a validated computer adaptive test to assess upper extremity functional status. Change = (Week (4, 6) Score - Baseline Score)

Time frame: Baseline and Week 4, Week 6

Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score - Crossover Condition

The PROMIS UE computer adaptive test is a validated computer adaptive test to assess upper extremity functional status. Change = (Week (4, 6) Score - Baseline Score)

Time frame: Baseline and Week 4, Week 6

Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index

The AUSCAN Index is a 15-item scale measuring pain (5 items), stiffness (1 item) and function (9 items) during the preceding 48 hours. Possible scores range from 0 (none) to 4 (extreme). Change = (Week (4, 6) Score - Baseline Score)

Time frame: Baseline and Week 4, Week 6

Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index - Crossover Condition

Time frame: Baseline and Week 4, Week 6

Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH)

The QuickDASH is a validated, self-reported 11-item scale measuring disability. Possible scores range from 0 (no disability) to 100 (most severe disability. Change = (Week 4 Score - Baseline Score)

Time frame: Baseline and Week 4

Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH) - Crossover Condition

The QuickDASH is a validated, self-reported 11-item scale measuring disability. Possible scores range from 0 (no disability) to 100 (most severe disability. Change = (Week 4 Score - Baseline Score)

Time frame: Baseline and Week 4

Change from Baseline in perseverance on the Brief Resilience Index (BRI)

The BRI is a validated, self-reported 6-item validated tool to assess for resilience. Possible scores range from 1 (low resilience) to 5 (high resilience). Change = (Week (4, 6) Score - Baseline Score)

Time frame: Baseline and Week 4, Week 6

Change from Baseline in perseverance on the Brief Resilience Index (BRI) - Crossover Condition

Time frame: Baseline and Week 4, Week 6

Secondary Outcomes

Number of Participants With Treatment-Related Adverse Events

Treatment-related adverse events will be reported throughout the study by self-report and clinician-driven questions at each visit

Time frame: Through study completion, an average of 12 weeks

Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure

Blood pressure (SBP and DBP) in mmHg using Sphygmomanometer will be assessed by the researchers at baseline and follow-up

Time frame: Baseline and Week 4

Change from Baseline in Heart Rate

Heartbeats per minute (BPM) will be assessed by the researchers at baseline and follow-up

Time frame: Baseline and Week 4

Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure

Blood pressure (SBP and DBP) in mmHg using Sphygmomanometer will be assessed by the researchers at baseline and follow-up

Time frame: Week 4 and Week 6

Change from Baseline in Heart Rate

Heartbeats per minute (BPM) will be assessed by the researchers at baseline and follow-up

Time frame: Week 4 and Week 6

Change from baseline in serum comprehensive metabolic panel (CMP) parameters: glucose, blood urea nitrogen (BUN), Creatinine, Calcium

Change from baseline in serum comprehensive metabolic panel (CMP) parameters: glucose, BUN, Creatinine, Calcium (mg/dL) at baseline and follow up

Time frame: Through study completion, an average of 12 weeks

Change from baseline in serum liver panel parameters: Alanine transaminase (ALT), Alkaline phosphatase (ALP) and Aspartate aminotransferase (AST)

Change from baseline in serum liver panel parameters: ALT, ALP and AST (International units per liter) at baseline and follow up

A Randomized Controlled Trial of Oral CBD for the Treatment of Upper Extremity Musculoskeletal Pain

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts