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Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Tetrahydrocannabinol
Placebo
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Tetrahydrocannabinol, Chronic Widespread Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pain Relief Unit, Hadassah Medical OrganisationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tetrahydrocannabinol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Meaningful change in Total score on Fibromyalgia Impact Questionnaire (FIQ)

Secondary Outcome Measures

Meaningful change in Brief Pain Inventory average pain severity.

Full Information

First Posted
June 22, 2010
Last Updated
June 22, 2010
Sponsor
Hadassah Medical Organization
Collaborators
Hebrew University of Jerusalem
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1. Study Identification

Unique Protocol Identification Number
NCT01149018
Brief Title
Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia
Official Title
A Randomized, Double-blind, Placebo-controlled Trial of Oral Tetrahydrocannabinol (∆-9-THC) in Patients With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization
Collaborators
Hebrew University of Jerusalem

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Tetrahydrocannabinol, Chronic Widespread Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tetrahydrocannabinol
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tetrahydrocannabinol
Intervention Description
Oral solution of THC in concentration of 5mg/0.2ml. Dose regimen: 5mg 2-4 times/day as tolerated.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Orally administered olive oil. Dose: 0.2ml 2-4 times a day as tolerated
Primary Outcome Measure Information:
Title
Meaningful change in Total score on Fibromyalgia Impact Questionnaire (FIQ)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Meaningful change in Brief Pain Inventory average pain severity.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elyad Davidson, MD
Phone
+972 2677 6911
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Haroutiunian, M.Sc
Phone
+972 2677 6770
Email
simonh@ekmd.huji.ac.il
Facility Information:
Facility Name
Pain Relief Unit, Hadassah Medical Organisation
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia

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