Efficacy Trial of Oral Tetrahydrocannabinol in Patients W... | NCT01149018

Studies
Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia

NCT01149018

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Jun 23, 2010Estimated

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Fibromyalgia

Interventions

Tetrahydrocannabinol
Placebo

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Jul 2012Estimated

Completion Date

Oct 2012Estimated

First Submitted Date

Jun 22, 2010

First Submission Date that Met QC Criteria

Jun 22, 2010

First Posted Date

Jun 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2010

Last Update Posted Date

Jun 23, 2010Estimated

Name	Class
Hebrew University of Jerusalem	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tetrahydrocannabinol	Experimental		Drug: Tetrahydrocannabinol
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tetrahydrocannabinol	Drug	Oral solution of THC in concentration of 5mg/0.2ml. Dose regimen: 5mg 2-4 times/day as tolerated.	Tetrahydrocannabinol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Meaningful change in Total score on Fibromyalgia Impact Questionnaire (FIQ)		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Meaningful change in Brief Pain Inventory average pain severity.		8 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elyad Davidson, MD	Contact	+972 2677 6911
Simon Haroutiunian, M.Sc	Contact	+972 2677 6770		simonh@ekmd.huji.ac.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pain Relief Unit, Hadassah Medical Organisation	Recruiting	Jerusalem		91120	Israel

Condition Browse Module

MeSH Terms

ID	Term
D005356	Fibromyalgia
D059350	Chronic Pain

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013759	Dronabinol

Ancestor Terms

ID	Term
D002186	Cannabinoids
D013729	Terpenes
D006838	Hydrocarbons
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided