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NCT Number: NCT06213233

MIVetsCan: Cannabidiol (CBD)-Care Trial

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

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Catherine Klida

CONTACT

[email protected]

734-998-8010

Kevin Boehnke, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Other names: Epidiolex

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 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.

  2. 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

    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.

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

    Time frame: Days 1-28

    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.

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

    Time frame: Days 1-28

    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.

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

    Time frame: Baseline (day 1), 28

    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.

  6. Change in suicidal ideation based on Positive and Negative Suicide Ideation (PANSI) Inventory

    Time frame: Baseline (day 1), 28

    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.

  7. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Klida

CONTACT

[email protected]

734-998-8010

Sponsors and collaborators

Lead sponsor

Kevin Boehnke

Other

Collaborators

  • Michigan, State of, Licensing and Regulatory Affairs

Registry information

Official study title

Pragmatic Trial of Cannabidiol to Improve Chronic Pain Symptoms Among Veterans

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 19, 2024
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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