RECRUITING

MIVetsCan: Cannabidiol (CBD)-Care Trial

Conditions

Pain, Chronic Cannabidiol (CBD)Veterans Surveys Fitbit wearable

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Pragmatic Trial of Cannabidiol to Improve Chronic Pain Symptoms Among Veterans

Quick Facts

Study Start:2024-02-12

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06213233

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Ability to read and speak English sufficiently to allow for written informed consent and patient-reported outcomes measures * Armed Services Veteran * 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	* Not an Armed Services Veteran (or dishonorable discharge status) * 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 * Current diagnosis of cancer * Current valproate and clobazam use per self-report or medical records * Self-reported allergies to sesame oil or cannabis/cannabinoids

Inclusion Criteria

Exclusion Criteria

* Ability to read and speak English sufficiently to allow for written informed consent and patient-reported outcomes measures
* Armed Services Veteran
* 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

* Not an Armed Services Veteran (or dishonorable discharge status)
* 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
* Current diagnosis of cancer
* Current valproate and clobazam use per self-report or medical records
* Self-reported allergies to sesame oil or cannabis/cannabinoids

Contacts and Locations

Study Contact

Vivian Kurtz, MPH

CONTACT

734-998-7156

vkurtz@umich.edu

Principal Investigator

Kevin Boehnke, PhD

PRINCIPAL_INVESTIGATOR

University of Michigan

Study Locations (Sites)

University of Michigan

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: Kevin Boehnke

Kevin Boehnke, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-12

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-02-12

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Cannabidiol (CBD)
Veterans
Surveys
Fitbit wearable

Additional Relevant MeSH Terms

Pain, Chronic