NCT06213233 · Kevin Boehnke
MIVetsCan: Cannabidiol (CBD)-Care Trial
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Placebo
Participant will take placebo days 1-28 during study treatment. Given the pragmatic design, participants will be instructed to take the study drug whenever participants wish, with suggested starting dosing of 0.2 milliliter (mL) in the morning and 0.2mL in the evening (up to 1.2mL per day).
DRUG
Cannabidiol
Participant will take Epidiolex days 1-28 during study treatment. Given the pragmatic design, participants will be instructed to take the study drug whenever participants wish, with suggested starting dosing of 0.2 milliliter (mL) in the morning and 0.2mL in the evening (up to 1.2mL per day).
Primary outcome measures
Global impression of change (PGIC) between groups at end of treatment (Day 28)
Time frame: Day 28
This is a 1-item survey that measures patient perceptions of intervention success. This survey is scored from 1 to 7, where lower scores indicate a better outcome.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Ann Arbor, Michigan
Collaborators
Michigan, State of, Licensing and Regulatory Affairs
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 1, 2026 · Source of record for eligibility and locations