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

Sponsors

Lead Sponsor: Hadassah Medical Organization

Collaborator: Hebrew University of Jerusalem

Source Hadassah Medical Organization
Brief Summary

The objective of the study is to evaluate the effectiveness of oral tetrahydrocannabinol in patients suffering from Fibromyalgia

Overall Status Unknown status
Start Date 2010-06-01
Completion Date 2012-10-01
Primary Completion Date 2012-07-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Meaningful change in Total score on Fibromyalgia Impact Questionnaire (FIQ) 8 weeks
Secondary Outcome
Measure Time Frame
Meaningful change in Brief Pain Inventory average pain severity. 8 weeks
Enrollment 80
Condition
Intervention

Intervention Type: Drug

Intervention Name: Tetrahydrocannabinol

Description: Oral solution of THC in concentration of 5mg/0.2ml. Dose regimen: 5mg 2-4 times/day as tolerated.

Arm Group Label: Tetrahydrocannabinol

Intervention Type: Drug

Intervention Name: Placebo

Description: Orally administered olive oil. Dose: 0.2ml 2-4 times a day as tolerated

Arm Group Label: Placebo

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Elyad Davidson, MD

Phone: +972 2677 6911

Location
Facility: Status: Pain Relief Unit, Hadassah Medical Organisation
Location Countries

Israel

Verification Date

2010-06-01

Responsible Party

Name Title: Elyad Davidson, MD

Organization: Hadassah Medical Organization

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Tetrahydrocannabinol

Type: Experimental

Label: Placebo

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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