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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Michigan
Ann Arbor, Michigan 48109
Contact:
Vivian Kurtz, MPH
734-998-7156
vkurtz@umich.edu

More Details

Status
Recruiting
Sponsor
Kevin Boehnke

Study Contact

Vivian Kurtz, MPH
734-998-7156
vkurtz@umich.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.