MIVetsCan: Cannabidiol (CBD)-Care Trial

NCT ID
NCT06213233
Registry status
Recruiting
Study type
Interventional
Phase
Phase 2
Sponsor
Kevin Boehnke
Conditions
Pain, Chronic

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Pragmatic Trial of Cannabidiol to Improve Chronic Pain Symptoms Among Veterans

Enrollment: 468 participants (Estimated).

What is being studied

  • Intervention: Cannabidiol
  • Drug: Cannabidiol
  • Intervention: Cannabinoids
  • Intervention: Hydrocarbons
  • Intervention: Organic Chemicals
  • Drug: Placebo
  • Intervention: Terpenes

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * 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 Exclusion Criteria: * Not an Armed Services Veteran * Inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in English) * Participant reports pregnancy or are nursing * Planning to move out of a state with legal recreational marijuana use during course of study * Risk for imminent harm - Suicidal ideation or wish to die as assessed per protocol * Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol * Participation in any other clinical trials over the course of this study * Medical or psychiatric conditions that in the judgment of study personnel would preclude participation in this study (e.g., psychosis, suicidal ideation; note that stable anxiety and depression are not exclusions) * Having a serious or unstable hepatic disease (e.g., non-alcoholic fatty liver disease or liver cirrhosis) * Individuals with major neurological disorders, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, and seizures * Recent/new diagnosis of cancer within the past 3 years (other than localized melanoma, localized basal cell carcinoma, localized squamous cell carcinoma treated or untreated) * Current valproate and clobazam use per self-report or medical records * Self-reported allergies to sesame oil or cannabis/cannabinoids

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Michigan, United States: 1

Sample of listed locations

  • University of Michigan — Ann Arbor, Michigan, 48109, United States — Recruiting

Study details

Start date
February 12, 2024
Primary completion date
December 1, 2028
Completion date
December 1, 2028
First posted
January 19, 2024
Collaborators
Michigan, State of, Licensing and Regulatory Affairs

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06213233
Registry last updated
June 1, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT06213233 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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