Effects of CBD on chronic pain in veterans
Pragmatic Trial of Cannabidiol to Improve Chronic Pain Symptoms Among Veterans
This study tests whether CBD can help veterans with chronic pain feel better compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 468 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06213233 on ClinicalTrials.gov |
What this trial studies
This research investigates the impact of cannabidiol (CBD) on chronic pain symptoms in veterans. Participants will be randomly assigned to receive either CBD or a placebo, allowing for a comparison of pain relief between the two groups. The study aims to determine if CBD can significantly improve pain management for veterans suffering from chronic pain. Participants must be enrolled in a pain registry and agree to specific guidelines regarding cannabis use during the study.
Who should consider this trial
Good fit: Ideal candidates are armed services veterans experiencing moderate to severe chronic pain who are interested in using cannabis for pain management.
Not a fit: Patients who are not veterans or those who do not report chronic pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective pain management option for veterans suffering from chronic pain.
How similar studies have performed: Other studies have shown promising results with CBD for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Kevin Boehnke, PhD — University of Michigan
- Study coordinator: Vivian Kurtz, MPH
- Email: vkurtz@umich.edu
- Phone: 734-998-7156
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.