MIVetsCan: Cannabidiol (CBD)-Care Trial

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

Study Overview

• Status: Recruiting
• Conditions: Pain, Chronic
• Intervention / Treatment: Drug: Placebo; Drug: Cannabidiol

• Study Type: Interventional
• Enrollment (Estimated): 468
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Catherine Klida; Phone Number: 734-998-8010; Email: crklida@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Catherine Klida; Phone Number: 734-998-8010; Email: crklida@med.umich.edu
      • Principal Investigator: Kevin Boehnke, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	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).
Experimental: Cannabidiol	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).; Other Names: Epidiolex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Days 1-28
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.	Days 1-28

Collaborators and Investigators

• Sponsor: Kevin Boehnke
• Collaborators: Michigan, State of, Licensing and Regulatory Affairs
• Investigators: Principal Investigator: Kevin Boehnke, PhD, University of Michigan

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Veterans; Cannabidiol (CBD); Surveys; Fitbit wearable
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Organic Chemicals; Hydrocarbons; Terpenes; Cannabinoids; Cannabidiol
• Other Study ID Numbers: HUM00231202; VMR2022-03 (Other Identifier: Michigan, State of, Licensing and Regulatory Affairs)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No