Cannabidiol for Reduction of Brain Neuroinflammation

PHASE2RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

January 4, 2022

Primary Completion Date

September 1, 2026

Study Completion Date

December 15, 2026

Conditions
Back PainDepressive Symptoms
Interventions
DRUG

CBD

Epidiolex, an agent within the anti-epileptic drug class, will be used. Epidiolex, Greenwich Biosciences Inc.'s CBD formulation, is a 100 mg/mL purified oral solution, dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring. The drug is formulated from extracts prepared from Cannabis sativa L. plants that have a defined chemical profile and contain consistent levels of CBD as the principal phytocannabinoid. Extracts from these plants are processed to yield pure (\>95%) CBD that typically contains less than 0.5% (w/w) THC. Cannabidiol is the active ingredient in Epidiolex; inactive ingredients include dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose. Of note, CBD has no psychoactive properties.

OTHER

Placebo

Placebo CBD will be identical to the active CBD, a 100 mg/mL purified oral solution, dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring, but with no CBD.

Trial Locations (1)

02114

RECRUITING

Massachusetts General Hospital, Boston

All Listed Sponsors
lead

Massachusetts General Hospital

OTHER