MIVetsCan: Cannabidiol (CBD)-Care Trial

NCT06213233 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: HUM00231202VMR2022-03
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 1

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

Keywords

Cannabidiol (CBD); Veterans; Surveys; Fitbit wearable

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Chronic pain severity between groups in the study period (Days 1 - 28)

  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

  baseline (day 1), day 28

• Anxiety based on the Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1

  Days 1-28

• Sleep disturbance based on the Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1

  Days 1-28

• Change in suicidal ideation based on the Negative Suicide Ideation questionnaire (PANSI)

  Baseline (day 1), 28

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Cannabidiol

EXPERIMENTAL

Drug: Cannabidiol

Interventions

Placebo 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).

Placebo

Cannabidiol 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).

Also known as: Epidiolex

Cannabidiol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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
• Participation in any other clinical trials over the course of this study
• 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

Sponsors & Collaborators

• Kevin Boehnke: lead
• Michigan, State of, Licensing and Regulatory Affairs: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 38951902 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Kevin Boehnke, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vivian Kurtz, MPH

CONTACT

734-998-7156; vkurtz@umich.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: February 12, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)