MIVetsCan: Cannabidiol (CBD)-Care Trial

Pain, Chronic Clinical Trial

Official title:

Pragmatic Trial of Cannabidiol to Improve Chronic Pain Symptoms Among Veterans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06213233
• Other study ID #: HUM00231202
• Secondary ID: VMR2022-03
• Status: Recruiting
• Phase: Phase 2
• Start date: February 12, 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: Vivian Kurtz, MPH
• Phone: 734-998-7156
• Email: vkurtz[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 468
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Kevin Boehnke	Michigan, State of, Licensing and Regulatory Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Chronic pain severity between groups in the study period (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.	Days 1-28
Secondary	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	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.	baseline (day 1), day 28
Secondary	Anxiety based on the Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1	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.	Days 1-28
Secondary	Sleep disturbance based on the Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1	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.	Days 1-28
Secondary	Change in suicidal ideation based on the Negative Suicide Ideation questionnaire (PANSI)	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.	Baseline (day 1), 28
Secondary	Change in suicidal ideation based on Positive and Negative Suicide Ideation (PANSI) Inventory	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.	Baseline (day 1), 28
Secondary	Safety assessed by the number of adverse events that are possibly, probably, or definitely related to the study drug between groups	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.	Days 1-28