Pain, ChronicPhase 2NCT06213233
MIVetsCan: Cannabidiol (CBD)-Care Trial
A Phase 2 study testing Cannabidiol in people with Pain, Chronic, run by Kevin Boehnke at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 468 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2024to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Catherine Klida, 734-998-8010, crklida@med.umich.edu
Kevin Boehnke, PhD
About this study
Official title: Pragmatic Trial of Cannabidiol to Improve Chronic Pain Symptoms Among Veterans
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
- Conditions
- Pain, Chronic
- Being tested
- Placebo, Cannabidiol
- Keywords
- Cannabidiol (CBD), Veterans, Surveys, Fitbit wearable
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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).
CannabidiolDrug
Also called Epidiolex
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).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Cannabidiol | Experimental | Not described Receives: Drug: Cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global impression of change (PGIC) between groups at end of treatment (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.
Measured: Day 28
Secondary outcomes (7)
Chronic pain severity between groups in the study period (Days 1 - 28)
Aggregated worst pain intensity (0-10 numerical rating scale) between groups during 7-day epochs from day 1 through day 28. Higher scores indicate worse pain.
Measured: Days 1-28
Change in pain interference based on the pain interference 4a short form items from the Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1
There are 4-items on this survey that participants will complete regarding pain interference from not at all (1) - very much (5). Scores range from 4-20 with a higher score meaning more interference.
Measured: baseline (day 1), day 28
Anxiety based on the Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1
There are 4-items on this survey that participants will complete regarding anxiety from never (1) - always (5). Scores range from 4-20 with a higher score meaning more anxiety.
Measured: Days 1-28
Sleep disturbance based on the Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1
This is a 4-item patient-reported scale indicating sleep quality. Scores range 4 to 20 with a higher score correspond to higher levels of sleep disturbance.
Measured: Days 1-28
Change in suicidal ideation based on the Negative Suicide Ideation questionnaire (PANSI)
The 8-items of vulnerability to suicidality participants will complete with answers from none of the time (1)-most of the time (5). Scores range from 8-40 with a lower score having fewer suicidal ideations.
Measured: Baseline (day 1), 28
Change in suicidal ideation based on Positive and Negative Suicide Ideation (PANSI) Inventory
This is a 14-item subjectively completed inventory that consisted of 2 subscales: the PANSI-negative suicide ideation (NSI) subscale composed of 8 items and the positive ideation (PI) subscale consisting of 6 items. The possible total scores on the PANSI-NSI and PANSI-PI subscales range from 8 to 40 and 6 to 30, respectively. Higher scores on the PANSI-NSI and lower scores on the PANSI-PI reflect greater risk for suicidal behavior.
Measured: Baseline (day 1), 28
Safety assessed by the number of adverse events that are possibly, probably, or definitely related to the study drug between groups
Number of participants having the event, severity, expectedness, and relatedness to the study treatment. The study will utilize the Common Terminology Criteria for Adverse Events v.5.0.
Measured: Days 1-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start12 Feb 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kevin Boehnke
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan, State of, Licensing and Regulatory Affairs
- Responsible party
- Sponsor-investigator, Kevin Boehnke, University of Michigan
- Investigators
- Kevin Boehnke, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213233
- Sponsor's protocol ID
- HUM00231202
- Other IDs
- VMR2022-03
- Status last verified
- May 2026
- First submitted
- 9 Jan 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bergmans RS, Wegryn-Jones R, Klida C, Kurtz V, Thomas L, Williams DA, Clauw DJ, Kidwell KM, Bohnert ASB, Boehnke KF. Protocol for a pragmatic trial of Cannabidiol (CBD) to improve chronic pain symptoms among United States Veterans. BMC Complement Med Ther. 2024 Jun 29;24(1):250. doi: 10.1186/s12906-024-04558-3.
PubMed 38951902
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Trial of Cannabidiol to Improve Chronic Pain Symptoms Among Veterans
- ClinicalTrials.gov ID
- NCT06213233
- Acronym / sponsor ID
- HUM00231202
- Conditions
- Pain, Chronic
- Keywords
- Cannabidiol (CBD), Veterans, Surveys, Fitbit wearable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- Kevin BoehnkeUniversity, hospital or other
- Collaborators
- Michigan, State of, Licensing and Regulatory Affairs
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Cannabidiol | Experimental | Drug: Cannabidiol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboParticipant 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 | Placebo |
| CannabidiolAlso: EpidiolexParticipant 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). | Drug | Cannabidiol |
Primary outcome
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.
7 secondary outcomes
Chronic pain severity between groups in the study period (Days 1 - 28)
Time frame: Days 1-28
Change in pain interference based on the pain interference 4a short form items from the Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1
Time frame: baseline (day 1), day 28
Anxiety based on the Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1
Time frame: Days 1-28
Sleep disturbance based on the Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1
Time frame: Days 1-28
Change in suicidal ideation based on the Negative Suicide Ideation questionnaire (PANSI)
Time frame: Baseline (day 1), 28
Change in suicidal ideation based on Positive and Negative Suicide Ideation (PANSI) Inventory
Time frame: Baseline (day 1), 28
Safety assessed by the number of adverse events that are possibly, probably, or definitely related to the study drug between groups
Time frame: Days 1-28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Derived from this study: PubMed 38951902Bergmans RS, Wegryn-Jones R, Klida C, Kurtz V, Thomas L, Williams DA, Clauw DJ, Kidwell KM, Bohnert ASB, Boehnke KF. Protocol for a pragmatic trial of Cannabidiol (CBD) to improve chronic pain symptoms among United States Veterans. BMC Complement Med Ther. 2024 Jun 29;24(1):250. doi: 10.1186/s12906-024-04558-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin Boehnke, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol in people with Pain, Chronic, run by Kevin Boehnke at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Klida (734-998-8010, crklida@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global impression of change (PGIC) between groups at end of treatment (Day 28) (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06213233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.