Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT05020028
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Knee Arthritis

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Cannabidiol (CBD) — DRUG
    Patients will be dispensed enough 25mg cannabidiol (CBD) Orally Disintegrating Tablets (ODT) to take a standard dose of 50mg three times daily for 84 days.
  • Placebo — DRUG
    25mg Placebo ODT looks like the cannabidiol (CBD) Orally Disintegrating Tablets (ODT), but contains no active ingredients.

Study Details

The purpose of this study is to see if cannabidiol (CBD) orally dissolving tablets (ODTs) can lessen pain, improve function, and improve patient satisfaction in cases of knee osteoarthritis. CBD comes from the cannabis plant and is non-psychoactive (i.e. does not produce a 'high' or altered mental state) as compared to tetrahydrocannabinol (THC), another compound found in cannabis. Researchers are studying different forms of CBD for potential use in treating pain, inflammation, and illnesses.

Key Dates

Start date
Jun 22, 2022
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CBD Group
    The first cohort will take two 25mg cannabidiol (total dose: 50mg) Orally Disintegrating Tablets (CBD ODT) three times daily for a maximum dose of 150mg per day.
  • Placebo Comparator: Placebo Group
    Cohort 2 will receive the same instructions, but with the placebo Orally Disintegrating Tablets (ODT) instead.

Primary Outcome Measure

VAS Pain Severity Score [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
Michael Alaia, MD (PRINCIPAL_INVESTIGATOR)

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By research site
NYU Langone Health· New York, NY

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