MIVetsCan: Cannabidiol (CBD)-Care Trial

Official title

Pragmatic Trial of Cannabidiol to Improve Chronic Pain Symptoms Among Veterans

Overview

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

Interventions

• 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).
• 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).

Primary outcome measures

• Global impression of change (PGIC) between groups at end of treatment (Day 28) [Time frame: Day 28]

Secondary outcome measures (7)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Michigan — Ann Arbor

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. PMID 38951902

Identifiers

NCT: NCT06213233 · HUM00231202 · VMR2022-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗