Biosignature of the Response to Treatment With Cannabis Oil in Individuals With Fibromyalgia

PHASE2RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

May 30, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2027

Conditions
Fibromyalgia
Interventions
DRUG

Cannabis Oil (5% THC/5% CBD)

Cannabis oil containing a balanced formulation of 5% tetrahydrocannabinol (THC) and 5% cannabidiol (CBD). Administered sublingually over a three-month period, starting with a six-week titration phase to optimize dosing, followed by maintenance.

DRUG

Sham Cannabis Oil

Placebo oil visually and chemically matched to the active cannabis oil but devoid of active cannabinoids (THC/CBD). Administered sublingually over three months, mirroring the active arm's titration and maintenance schedule.

Trial Locations (1)

3109601

RECRUITING

Rambam Health Care Campus, Haifa

All Listed Sponsors
collaborator

American Fibromyalgia Syndrome Association

OTHER

lead

Rambam Health Care Campus

OTHER