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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01149018

Enrollment

Registered

2010-06-23

Start date

2010-06-30

Completion date

2012-10-31

Last updated

2010-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Fibromyalgia, Tetrahydrocannabinol, Chronic Widespread Pain

Brief summary

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

Interventions

DRUGTetrahydrocannabinol

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Israel

Contacts

Primary ContactElyad Davidson, MD

+972 2677 6911

Backup ContactSimon Haroutiunian, M.Sc

simonh@ekmd.huji.ac.il+972 2677 6770

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026