Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia

Hadassah Medical Center

Status: Unknown

Conditions: Fibromyalgia

Treatments: Drug: Tetrahydrocannabinol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01149018

THC-FMS-HMO-CTIL

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Tetrahydrocannabinol

Experimental group

Treatment:

Drug: Tetrahydrocannabinol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo