Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia
A Randomized, Double-blind, Placebo-controlled Trial of Oral Tetrahydrocannabinol (∆-9-THC) in Patients With Fibromyalgia
1 other identifier
interventional
80
1 country
1
Brief Summary
The objective of the study is to evaluate the effectiveness of oral tetrahydrocannabinol in patients suffering from Fibromyalgia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 22, 2010
CompletedFirst Posted
Study publicly available on registry
June 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJune 23, 2010
June 1, 2010
2.1 years
June 22, 2010
June 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Meaningful change in Total score on Fibromyalgia Impact Questionnaire (FIQ)
8 weeks
Secondary Outcomes (1)
Meaningful change in Brief Pain Inventory average pain severity.
8 weeks
Study Arms (2)
Tetrahydrocannabinol
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Oral solution of THC in concentration of 5mg/0.2ml. Dose regimen: 5mg 2-4 times/day as tolerated.
Eligibility Criteria
You may qualify if:
- \- Adult (\>18y.o) Patient with Fibromyalgia, diagnosed by ACR criteria
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hadassah Medical Organizationlead
- Hebrew University of Jerusalemcollaborator
Study Sites (1)
Pain Relief Unit, Hadassah Medical Organisation
Jerusalem, 91120, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 22, 2010
First Posted
June 23, 2010
Study Start
June 1, 2010
Primary Completion
July 1, 2012
Study Completion
October 1, 2012
Last Updated
June 23, 2010
Record last verified: 2010-06