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Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT01149018
Recruitment Status : Unknown
Verified June 2010 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : June 23, 2010
Last Update Posted : June 23, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The objective of the study is to evaluate the effectiveness of oral tetrahydrocannabinol in patients suffering from Fibromyalgia

Condition or disease Intervention/treatment
Fibromyalgia Drug: Tetrahydrocannabinol Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Study Start Date : June 2010
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Dronabinol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

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 Posted: June 23, 2010    Key Record Dates
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:
Dronabinol
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
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