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Pragmatic Trial of Cannabidiol to Improve Chronic Pain Symptoms Among Veterans

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This research is studying the effects of cannabidiol (CBD), an active component from cannabis (a.k.a. marijuana), on Veterans' chronic pain. The purpose of this study is to better understand if CBD can improve pain symptoms in Veterans with chronic pain. Eligible participants will be randomly assigned to receive either placebo medication (not active) or CBD during the study period. The study hypotheses: \- CBD would improve overall pain symptoms compared to placebo

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Ability to read and speak English sufficiently to allow for written informed consent and patient-reported outcomes measures

• Armed Services Veteran

• All participants must have been enrolled in the MIVetsCan Pain Registry (HUM00223894) for at least 4 weeks and agree to continue participation in that study.

• Reports moderate to severe chronic pain defined by protocol

• Currently using or interested in using cannabis for pain management

• Self-reported willingness to refrain from or not increase current Tetrahydrocannabinol (THC) or other cannabis product use (including CBD) during the study intervention or other cannabinoid use during the study intervention

• Individuals of reproductive potential must agree to use acceptable birth control per protocol

• Participants must also agree not to donate sperm or eggs during study drug administration

• Willingness to attend all study visits (may be done virtually)

• Ability to take and to swallow the study medication and be willing to adhere to the treatment regimen

• Willingness to wear Fitbit or other similar sensor for passive-data collection

• Willingness to fill out daily diary via smartphone to assess symptom status, study drug use, and other cannabis use

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Vivian Kurtz, MPH
vkurtz@umich.edu
734-998-7156
Time Frame
Start Date: 2024-02-12
Estimated Completion Date: 2026-12
Participants
Target number of participants: 468
Treatments
Placebo_comparator: Placebo
Experimental: Cannabidiol
Related Therapeutic Areas
Sponsors
Collaborators: Michigan, State of, Licensing and Regulatory Affairs
Leads: Kevin Boehnke

This content was sourced from clinicaltrials.gov

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