Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Trial of Oral Tetrahydrocannabinol (∆-9-THC) in Patients With Fibromyalgia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01149018
• Other study ID #: THC-FMS-HMO-CTIL
• Status: Recruiting
• Phase: N/A
• First received: June 22, 2010
• Last updated: June 22, 2010
• Start date: June 2010
• Est. completion date: October 2012

Study information

• Verified date: June 2010
• Source: Hadassah Medical Organization
• Contact: Elyad Davidson, MD
• Phone: +972 2677 6911
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Tetrahydrocannabinol
Oral solution of THC in concentration of 5mg/0.2ml. Dose regimen: 5mg 2-4 times/day as tolerated.
• Placebo
Orally administered olive oil. Dose: 0.2ml 2-4 times a day as tolerated

Locations

Country	Name	City	State
Israel	Pain Relief Unit, Hadassah Medical Organisation	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meaningful change in Total score on Fibromyalgia Impact Questionnaire (FIQ)		8 weeks	No
Secondary	Meaningful change in Brief Pain Inventory average pain severity.		8 weeks	No