MIVetsCan: Cannabidiol (CBD)-Care Trial
ConditionPain, Chronic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKevin Boehnke
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
DrugParticipant 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
DrugParticipant 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).
Treatment groups
468 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: CannabidiolExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 28Secondary outcomes
1
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.
Time frame
Days 1-282
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.
Time frame
baseline (day 1), day 283
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.
Time frame
Days 1-284
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.
Time frame
Days 1-28Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kevin Boehnke
Lead sponsor
University of Michigan
Sponsor institution
Michigan, State of, Licensing and Regulatory Affairs
Collaborator
Source ClinicalTrials.gov