Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia

Hadassah Medical Organization80 enrolled

Overview

The objective of the study is to evaluate the effectiveness of oral tetrahydrocannabinol in patients suffering from Fibromyalgia

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Fibromyalgia

Interventions

TetrahydrocannabinolDRUG

Oral solution of THC in concentration of 5mg/0.2ml. Dose regimen: 5mg 2-4 times/day as tolerated.

PlaceboDRUG

Orally administered olive oil. Dose: 0.2ml 2-4 times a day as tolerated

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Adult (\>18y.o) Patient with Fibromyalgia, diagnosed by ACR criteria Exclusion Criteria: \- Children \< 18 years old Patients with following psychiatric disorders: * Psychosis or history of acute psychosis * Schizophrenia * Bipolar disorder Patients smoking marijuana, using hashish or any other form of cannabis. Patients with history of drug abuse or illicit drug use Patients receiving chronic treatment with strong opioids (Morphine, Oxycodone, Fentanyl, Methadone, Hydromorphone, Buprenorphine, Pethidine). Weak opioids as Tramadol or Propoxyphene will be allowed. Pregnant patients

Locations (1)

Pain Relief Unit, Hadassah Medical Organisation

Jerusalem, Israel

RECRUITING

Outcomes

Primary Outcomes

Meaningful change in Total score on Fibromyalgia Impact Questionnaire (FIQ)

Time frame: 8 weeks

Secondary Outcomes

Meaningful change in Brief Pain Inventory average pain severity.

Time frame: 8 weeks

Central Contacts

Elyad Davidson, MD

CONTACT

+972 2677 6911

Simon Haroutiunian, M.Sc

CONTACT

+972 2677 6770 simonh@ekmd.huji.ac.il

Data from ClinicalTrials.gov

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