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Cannabinoid
CBD for Chronic Pain
Phase 2
Recruiting
Led By Kevin Boehnke, PhD
Research Sponsored by Kevin Boehnke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Reports moderate to severe chronic pain defined by protocol
Be older than 18 years old
Must not have
Current diagnosis of cancer
Having a serious or unstable hepatic disease (e.g., non-alcoholic fatty liver disease or liver cirrhosis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1-28
Summary
This trial is looking at the effects of CBD, which comes from marijuana, on chronic pain in Veterans. The goal is to see if CBD can help improve pain symptoms in Veterans with chronic pain. Participants
Who is the study for?
This trial is for Veterans experiencing chronic pain. Participants will be randomly assigned to receive either a placebo or CBD, which is an active component of cannabis thought to help with pain.
What is being tested?
The study aims to determine if CBD can provide better relief from chronic pain symptoms in Veterans compared to a placebo (a substance with no therapeutic effect).
What are the potential side effects?
While the trial's description doesn't specify side effects, common ones associated with CBD may include tiredness, diarrhea, and changes in appetite or weight.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience chronic pain that is moderate to severe.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently diagnosed with cancer.
Select...
I do not have serious liver conditions like cirrhosis.
Select...
I am currently taking valproate and clobazam.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1-28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1-28
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Global impression of change (PGIC) between groups at end of treatment (Day 28)
Secondary study objectives
Anxiety based on the Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1
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
Change in suicidal ideation based on Positive and Negative Suicide Ideation (PANSI) Inventory
+4 moreSide effects data
From 2022 Phase 2 & 3 trial • 90 Patients • NCT0438761729%
Tiredness
20%
Constipation
18%
Drowsiness
11%
Poor sleep
11%
Dizziness
9%
Poor Appetite
9%
Headache
4%
Nausea
4%
Itching
2%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
CBD Oil Group
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CannabidiolExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
2021
Completed Phase 3
~1010
Find a Location
Who is running the clinical trial?
Michigan, State of, Licensing and Regulatory AffairsUNKNOWN
2 Previous Clinical Trials
490 Total Patients Enrolled
2 Trials studying Chronic Pain
490 Patients Enrolled for Chronic Pain
Kevin BoehnkeLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Kevin Boehnke, PhDPrincipal InvestigatorUniversity of Michigan
2 Previous Clinical Trials
490 Total Patients Enrolled
2 Trials studying Chronic Pain
490 Patients Enrolled for Chronic Pain
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