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
Recruitment status was Recruiting
Sponsor:
Hadassah Medical Organization
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
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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:
MedlinePlus related topics:
Fibromyalgia
Drug Information available for:
Dronabinol
U.S. FDA Resources
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
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 Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Tetrahydrocannabinol Hallucinogens |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013