Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia

June 22, 2010 updated by: Hadassah Medical Organization

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Elyad Davidson, MD
  • Phone Number: +972 2677 6911

Study Contact Backup

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Recruiting
        • Pain Relief Unit, Hadassah Medical Organisation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Orally administered olive oil. Dose: 0.2ml 2-4 times a day as tolerated
Experimental: Tetrahydrocannabinol
Drug: Tetrahydrocannabinol
Oral solution of THC in concentration of 5mg/0.2ml. Dose regimen: 5mg 2-4 times/day as tolerated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Meaningful change in Total score on Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Meaningful change in Brief Pain Inventory average pain severity.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Collaborators

Hebrew University of Jerusalem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

June 22, 2010

First Submitted That Met QC Criteria

June 22, 2010

First Posted (Estimate)

June 23, 2010

Study Record Updates

Last Update Posted (Estimate)

June 23, 2010

Last Update Submitted That Met QC Criteria

June 22, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THC-FMS-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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