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Not yet recruitingNCT06695195Updated Apr 9, 2025

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

A Phase 1 interventional study of Cannabidiol (CBD) and Placebo in Upper Extremity Muscle Pain, Upper Extremity Bone Pain and Upper Extremity Pain, sponsored by Brent DeGeorge. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-09.

Sponsored by Brent DeGeorge · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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].

Read the detailed description

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.

02

Conditions studied

  • Upper Extremity Muscle Pain
  • Upper Extremity Bone Pain
  • Upper Extremity Pain

Browse trials for

Keywords

  • Wrist Muscular Pain
  • Forearm Bone Pain
  • Forearm Muscular Pain
  • Hand Pain
  • CBD
  • oral CBD
  • Upper Arm Muscular Pain
  • Upper Arm Bone Pain
  • Wrist Joint Pain
  • Wrist Bone Pain
  • Forearm Joint Pain
  • Upper Arm Joint Pain
03

In context

Myalgia

256 studies on the registry are indexed under Myalgia; 46 are open to participants now.

This study's planned enrollment of 100 is above the median of 44 across 216 interventional studies indexed under Myalgia.

Browse Myalgia studies →

Lead sponsor

Brent DeGeorge is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Provision of signed and dated 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 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

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 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 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 , 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:

    • >5x or total >2×ULN
    • ALT or AST>3 × ULN and total bilirubin>2xULN or >1.5

  17. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of :

    • 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.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Oral CBD

    Oral CBD 25 mg capsules taken twice each day for 4 weeks.

    Drug: Cannabidiol (CBD)

  • Placebo comparator
    Placebo

    Oral placebo capsules taken twice each day for 4 weeks

    Drug: Placebo

Interventions

  • DrugCannabidiol (CBD)

    25 mg capsule twice daily

    Also known as: Green Valley Nutrition, LLC, Cannabidiol

  • DrugPlacebo

    25 mg capsule twice daily

06

What researchers measure

Primary outcomes

  1. 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

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

    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

  3. 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

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

    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

  5. 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

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

    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

  7. 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

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

    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

  9. 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

  10. 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

  11. 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

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

    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

  13. 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

  14. 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

  15. 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

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

    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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  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

  5. 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

  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

  7. 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

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

  8. Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Chloride

    Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Chloride (umol/L) at baseline and follow up

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

  9. Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Sodium, Potassium, Chloride, Carbon Dioxide

    Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Sodium, Potassium, Chloride, Carbon Dioxide (meq/L) at baseline and follow up

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

  10. Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Bilirubin

    Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Bilirubin (umol/L) at baseline and follow up

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

  11. Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Prothrombin time- International normalized ratio (PT-INR)

    Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Prothrombin time- International normalized ratio (PT (seconds)-INR) at baseline and follow up

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

  12. Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Protein, Albumin

    Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Protein, Albumin (g/dL) at baseline and follow up

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

  13. Change from baseline in serum complete blood count (CBC) parameters: Red Blood Cells (CBC), White Blood Cells (WBC), Platelets

    Change from baseline in serum complete blood count (CBC) parameters: RBC, WBC, Platelets (uL) at baseline and follow up

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

  14. Change from baseline in serum complete blood count (CBC) parameters: Hemoglobin

    Change from baseline in serum complete blood count (CBC) parameters: Hemoglobin (g.dL) at baseline and follow up

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

  15. Change from baseline in serum complete blood count (CBC) parameters: Hematocrit

    Change from baseline in serum complete blood count (CBC) parameters: Hematocrit (percentage) at baseline and follow up

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

  16. Change from baseline in serum complete blood count (CBC) parameters: Mean Corpuscular Volume (MCV)

    Change from baseline in serum complete blood count (CBC) parameters: Mean Corpuscular Volume (MCV) (pg) at baseline and follow up

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

  17. Change from baseline in serum complete blood count (CBC) parameters: the amount of hemoglobin per red blood cell.(MCH)

    Change from baseline in serum complete blood count (CBC) parameters: the amount of hemoglobin per red blood cell.(MCH) (pg) at baseline and follow up

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

07

Study locations

1 site
08

References and documents

Publications

  • Russo E.B., Mathre M.L., Byrne A., Velin R., Bach P.J., Sanchez-Ramos J., et. al.: Chronic cannabis use in the compassionate investigational new drug program: an examination of benefits and adverse effects of legal clinical cannabis. J Cannabis Ther 2002; 2: pp. 3-57.
  • Stockings E, Zagic D, Campbell G, Weier M, Hall WD, Nielsen S, Herkes GK, Farrell M, Degenhardt L. Evidence for cannabis and cannabinoids for epilepsy: a systematic review of controlled and observational evidence. J Neurol Neurosurg Psychiatry. 2018 Jul;89(7):741-753. doi: 10.1136/jnnp-2017-317168. Epub 2018 Mar 6. PubMed 29511052 ↗
  • Bruni N, Della Pepa C, Oliaro-Bosso S, Pessione E, Gastaldi D, Dosio F. Cannabinoid Delivery Systems for Pain and Inflammation Treatment. Molecules. 2018 Sep 27;23(10):2478. doi: 10.3390/molecules23102478. PubMed 30262735 ↗
  • Fader L, Scharf Z, DeGeorge BR Jr. Assessment of Medical Cannabis in Patients With Osteoarthritis of the Thumb Basal Joint. J Hand Surg Am. 2023 Mar;48(3):257-262.e1. doi: 10.1016/j.jhsa.2021.10.018. Epub 2021 Dec 8. PubMed 34893392 ↗
  • Ware MA, Wang T, Shapiro S, Collet JP; COMPASS study team. Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS). J Pain. 2015 Dec;16(12):1233-1242. doi: 10.1016/j.jpain.2015.07.014. Epub 2015 Sep 16. PubMed 26385201 ↗
  • Heineman JT, Forster GL, Stephens KL, Cottler PS, Timko MP, DeGeorge BR Jr. A Randomized Controlled Trial of Topical Cannabidiol for the Treatment of Thumb Basal Joint Arthritis. J Hand Surg Am. 2022 Jul;47(7):611-620. doi: 10.1016/j.jhsa.2022.03.002. Epub 2022 May 28. PubMed 35637038 ↗
  • MacCallum CA, Russo EB. Practical considerations in medical cannabis administration and dosing. Eur J Intern Med. 2018 Mar;49:12-19. doi: 10.1016/j.ejim.2018.01.004. Epub 2018 Jan 4. PubMed 29307505 ↗
  • Arzimanoglou A, Brandl U, Cross JH, Gil-Nagel A, Lagae L, Landmark CJ, Specchio N, Nabbout R, Thiele EA, Gubbay O, The Cannabinoids International Experts Panel; Collaborators. Epilepsy and cannabidiol: a guide to treatment. Epileptic Disord. 2020 Feb 1;22(1):1-14. doi: 10.1684/epd.2020.1141. PubMed 32096470 ↗
  • Chen JW, Borgelt LM, Blackmer AB. Cannabidiol: A New Hope for Patients With Dravet or Lennox-Gastaut Syndromes. Ann Pharmacother. 2019 Jun;53(6):603-611. doi: 10.1177/1060028018822124. Epub 2019 Jan 8. PubMed 30616356 ↗
  • Mechoulam R, Hanus L. Cannabidiol: an overview of some chemical and pharmacological aspects. Part I: chemical aspects. Chem Phys Lipids. 2002 Dec 31;121(1-2):35-43. doi: 10.1016/s0009-3084(02)00144-5. PubMed 12505688 ↗
  • Baron EP, Lucas P, Eades J, Hogue O. Patterns of medicinal cannabis use, strain analysis, and substitution effect among patients with migraine, headache, arthritis, and chronic pain in a medicinal cannabis cohort. J Headache Pain. 2018 May 24;19(1):37. doi: 10.1186/s10194-018-0862-2. PubMed 29797104 ↗
  • Brat GA, Agniel D, Beam A, Yorkgitis B, Bicket M, Homer M, Fox KP, Knecht DB, McMahill-Walraven CN, Palmer N, Kohane I. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ. 2018 Jan 17;360:j5790. doi: 10.1136/bmj.j5790. PubMed 29343479 ↗
  • Wolf JM, Atroshi I, Zhou C, Karlsson J, Englund M. Sick Leave After Surgery for Thumb Carpometacarpal Osteoarthritis: A Population-Based Study. J Hand Surg Am. 2018 May;43(5):439-447. doi: 10.1016/j.jhsa.2017.11.019. Epub 2018 Feb 7. PubMed 29428245 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06695195
Lead sponsor
Brent DeGeorge
Collaborators
The Plastic Surgery Foundation
Responsible party
Brent DeGeorge (Associate Professor of Plastic Surgery, University of Virginia) — Sponsor-investigator
First posted
Nov 19, 2024
Start date
Jun 2025 (estimated)
Primary completion
Mar 2026 (estimated)
Completion
Mar 2026 (estimated)
Last update
Apr 9, 2025

Study contacts

Lindsey Wilkin, BS
Contact
lm26z@virginia.edu
571-225-8756
Brent DeGeorge, MD, PhD
principal investigator · University of Virginia Department of Plastic Surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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