Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT05170451
Status:
WITHDRAWN
Last Update Posted:
2024-02-28
First Post:
2021-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topical CBD for Musculoskeletal Pain
Sponsor:
University of Virginia
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial of Topical Cannabidiol for the Treatment of Musculoskeletal Pain
Status:
WITHDRAWN
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to hurdles of obtaining regulatory approval.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: