MIVetsCan: Cannabidiol (CBD)-Care Trial

NCT ID: NCT06213233

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 468 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-12
• Study Completion Date: 2026-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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).

Cannabidiol

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

Epidiolex

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michigan, State of, Licensing and Regulatory Affairs

UNKNOWN

Sponsor Role: collaborator

Kevin Boehnke

OTHER

Sponsor Role: lead

Responsible Party

Kevin Boehnke

Research Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kevin Boehnke, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vivian Kurtz, MPH

Role: CONTACT

vkurtz@umich.edu

734-998-7156

Facility Contacts

Vivian Kurtz, MPH

Role: primary

vkurtz@umich.edu

734-998-7156

References

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.

Reference Type: DERIVED

PMID: 38951902 (View on PubMed)

Other Identifiers

VMR2022-03

Identifier Type: OTHER

Identifier Source: secondary_id

HUM00231202

Identifier Type: -

Identifier Source: org_study_id