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Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01149018
First Posted: June 23, 2010
Last Update Posted: June 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hebrew University of Jerusalem
Information provided by:
Hadassah Medical Organization
  Purpose
The objective of the study is to evaluate the effectiveness of oral tetrahydrocannabinol in patients suffering from Fibromyalgia

Condition Intervention
Fibromyalgia Drug: Tetrahydrocannabinol Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Trial of Oral Tetrahydrocannabinol (∆-9-THC) in Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Meaningful change in Total score on Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Meaningful change in Brief Pain Inventory average pain severity. [ Time Frame: 8 weeks ]

Estimated Enrollment: 80
Study Start Date: June 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tetrahydrocannabinol Drug: Tetrahydrocannabinol
Oral solution of THC in concentration of 5mg/0.2ml. Dose regimen: 5mg 2-4 times/day as tolerated.
Placebo Comparator: Placebo Drug: Placebo
Orally administered olive oil. Dose: 0.2ml 2-4 times a day as tolerated

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149018


Contacts
Contact: Elyad Davidson, MD +972 2677 6911
Contact: Simon Haroutiunian, M.Sc +972 2677 6770 simonh@ekmd.huji.ac.il

Locations
Israel
Pain Relief Unit, Hadassah Medical Organisation Recruiting
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Hebrew University of Jerusalem
  More Information

Responsible Party: Elyad Davidson, MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01149018     History of Changes
Other Study ID Numbers: THC-FMS-HMO-CTIL
First Submitted: June 22, 2010
First Posted: June 23, 2010
Last Update Posted: June 23, 2010
Last Verified: June 2010

Keywords provided by Hadassah Medical Organization:
Fibromyalgia
Tetrahydrocannabinol
Chronic Widespread Pain

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists