Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hebrew University of Jerusalem
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01149018
First received: June 22, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Meaningful change in Brief Pain Inventory average pain severity. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Elyad Davidson, MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01149018     History of Changes
Other Study ID Numbers: THC-FMS-HMO-CTIL
Study First Received: June 22, 2010
Last Updated: June 22, 2010
Health Authority: Israel: Ethics Commission

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

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

ClinicalTrials.gov processed this record on October 29, 2014