Pain, Chronic study: Cannabidiol
Official title MIVetsCan: Cannabidiol (CBD)-Care Trial
ClinicalTrials.gov ID: NCT06213233
What this study is testing
What is Epidiolex?
An investigational oral medication being studied as a potential treatment for chronic pain in veterans. It is designed to interact with the body's endocannabinoid system, which may help modulate pain signals.
Also referred to as Cannabidiol.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether CBD can improve pain symptoms compared to a fake pill.
- Who it's for
- Veterans who have ongoing chronic pain.
- What's involved
- Participants will be randomly given either CBD or a placebo and will take the medication as directed while completing study visits and pain assessments.
- Time commitment
- The trial lasts for the study period with regular visits as required by the protocol.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Reports moderate to severe chronic pain defined by protocol
- Currently using or interested in using cannabis for pain management
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Ann Arbor, Michigan, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.