NCT01149018
Unknown
Not Applicable
A Randomized, Double-blind, Placebo-controlled Trial of Oral Tetrahydrocannabinol (∆-9-THC) in Patients With Fibromyalgia
Overview
- Phase
- Not Applicable
- Intervention
- Tetrahydrocannabinol
- Conditions
- Fibromyalgia
- Sponsor
- Hadassah Medical Organization
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Meaningful change in Total score on Fibromyalgia Impact Questionnaire (FIQ)
- Last Updated
- 15 years ago
Overview
Brief Summary
The objective of the study is to evaluate the effectiveness of oral tetrahydrocannabinol in patients suffering from Fibromyalgia
Investigators
Eligibility 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
Arms & Interventions
Tetrahydrocannabinol
Intervention: Tetrahydrocannabinol
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Meaningful change in Total score on Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: 8 weeks
Secondary Outcomes
- Meaningful change in Brief Pain Inventory average pain severity.(8 weeks)
Study Sites (1)
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