CBD for Osteoarthritis (SLACK-OA Trial)

Phase 1 & 2

Recruiting

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

established clinical diagnosis of knee osteoarthritis (KOA)

moderate to severe knee pain (≥4/10) with physical activity in one or both knees

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 1 month, daily until 1 month

Summary

This trial aims to study the pain-relieving effects of cannabidiol (CBD) for people with osteoarthritis. Many active individuals have reported that CBD can help reduce pain and lessen the

Who is the study for?

This trial is for adults with knee osteoarthritis experiencing moderate to severe pain (at least 4 out of 10) during physical activity. It's aimed at those who seek an alternative to NSAIDs for managing their pain.

What is being tested?

The study tests the safety and effectiveness of Cannabidiol (CBD) extract in reducing knee pain caused by osteoarthritis, compared to a placebo. Participants will not know if they are receiving CBD or the placebo.

What are the potential side effects?

Potential side effects of CBD may include tiredness, diarrhea, changes in appetite/weight, and could affect liver enzymes. Placebo has no active ingredients but can cause similar symptoms due to the body's expectation of treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with knee osteoarthritis.

Select...

I experience knee pain of 4 or more out of 10 when active.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 1 month, daily until 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 1 month, daily until 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 month, daily until 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Physical Activity

Self-report Ratings of Knee Pain

+2 more

Secondary study objectives

Fear of Pain Questionnaire III (FPQ III)

Pain Anxiety Symptom Scale (PASS-20)

Pain Catastrophizing Scale (PCS)

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active DrugActive Control1 Intervention

Hemp supplement is a full spectrum CBD-rich formulation (\~10%) containing very low levels of THC (\<0.3%), along with all naturally occurring minor cannabinoids, terpenes, and essential oils from the plant extract.

Group II: Vehicle ControlPlacebo Group1 Intervention

A medium chain triglyceride-based mixing agent blended with coconut oil will be used as the placebo.

0 / 2Eligibility criteria met