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Cannabinoid

Cannabidiol 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1-28

Awards & highlights

Study 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.Check my eligibility

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).See study design

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 below

Select...

I experience chronic pain that is moderate to severe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1-28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1-28

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1-28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Global impression of change (PGIC) between groups at end of treatment (Day 28)

Secondary outcome measures

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 more

Side effects data

From 2022 Phase 2 & 3 trial • 90 Patients • NCT04387617

38%

Tiredness

24%

Drowsiness

24%

Poor sleep

22%

Constipation

18%

Poor Appetite

16%

Dizziness

Headache

Diarrhea

Nausea

Itching

100%

80%

60%

40%

20%

Study treatment Arm

CBD Oil Group

Control 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

0 / 1Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential candidates able to apply for participation in this ongoing trial?

"As indicated on clinicaltrials.gov, this specific investigation is not currently seeking participants. The trial was initially posted for public view on January 1st, 2024 and underwent its most recent revision on January 9th, 2024. It's worth noting that although this study is not actively recruiting at present, there are currently 391 alternative studies accepting candidates."

Answered by AI

What are the potential risks associated with the administration of Cannabidiol to patients?

"Based on the evaluation conducted by our team at Power, Cannabidiol's safety is rated as 2. This assessment aligns with it being a Phase 2 trial where some data supports its safety but no evidence regarding efficacy exists yet."

Answered by AI