Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia

Not Applicable

• Conditions: Fibromyalgia
• Interventions: Drug: Tetrahydrocannabinol; Drug: Placebo

• Registration Number: NCT01149018
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-06
• Study Start: 2010-06
• Study First Submitted: 2010-06-22
• Study First Submitted QC: 2010-06-22
• Last Update Submitted: 2010-06-22
• Study First Posted: 2010-06-23
• Last Update Posted: 2010-06-23
• Primary Completion: 2012-07
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tetrahydrocannabinol	Tetrahydrocannabinol	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Meaningful change in Total score on Fibromyalgia Impact Questionnaire (FIQ)	8 weeks

Secondary Outcome Measures

Name	Time	Method
Meaningful change in Brief Pain Inventory average pain severity.	8 weeks

Trial Locations

Locations (1)

Pain Relief Unit, Hadassah Medical Organisation; 🇮🇱 Jerusalem, Israel